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Efficacy, Safety and Pharmacokinetics of Sugammadex (Org 25969; MK-8616) at 3 Different Time Points After 0.6 mg/kg Esmeron® in Male Participants (P05940; MK-8616-020).

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ClinicalTrials.gov Identifier: NCT03519854
Recruitment Status : Completed
First Posted : May 9, 2018
Results First Posted : February 1, 2019
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Neuromuscular Blockade
Interventions Drug: Placebo
Drug: Sugammadex
Drug: Esmeron®
Enrollment 99
Recruitment Details Of the N=99 randomized participants, N=98 received treatment. Treated participants are counted as Started in the arm that most accurately describes the treatment received. If no treatment was received (N=1 participant), participants are counted as Started in the arm to which they were randomized.
Pre-assignment Details One participant originally randomized to receive 2 mg/kg Sugammadex, given 3 minutes after Esmeron® (Arm C), incorrectly received placebo. As a result, this participant is counted as Started/Treated in the “Arm A. Placebo; given 3 minutes after Esmeron®” arm.
Arm/Group Title Arm A. Placebo; Given 3 Minutes After Esmeron® Arm B. 1 mg/kg Sugammadex; Given 3 Minutes After Esmeron® Arm C. 2 mg/kg Sugammadex; Given 3 Minutes After Esmeron® Arm D. 4 mg/kg Sugammadex; Given 3 Minutes After Esmeron® Arm E. 6 mg/kg Sugammadex; Given 3 Minutes After Esmeron® Arm F. 8 mg/kg Sugammadex; Given 3 Minutes After Esmeron® Arm G. Placebo; Given 5 Minutes After Esmeron® Arm H. 1 mg/kg Sugammadex; Given 5 Minutes After Esmeron® Arm I. 2 mg/kg Sugammadex; Given 5 Minutes After Esmeron® Arm J. 4 mg/kg Sugammadex; Given 5 Minutes After Esmeron® Arm K. 6 mg/kg Sugammadex; Given 5 Minutes After Esmeron® Arm L. 8 mg/kg Sugammadex; Given 5 Minutes After Esmeron® Arm M. Placebo; Given 15 Minutes After Esmeron® Arm N. 1 mg/kg Sugammadex; Given 15 Minutes After Esmeron® Arm O. 2 mg/kg Sugammadex; Given 15 Minutes After Esmeron® Arm P. 4 mg/kg Sugammadex; Given 15 Minutes After Esmeron® Arm Q. 6 mg/kg Sugammadex; Given 15 Minutes After Esmeron® Arm R. 8 mg/kg Sugammadex; Given 15 Minutes After Esmeron®
Hide Arm/Group Description Placebo (single intravenous (IV) bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Sugammadex (1 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Sugammadex (2 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Sugammadex (4 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Sugammadex (6 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Sugammadex (8 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Placebo (single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Sugammadex (1 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Sugammadex (2 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Sugammadex (4 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Sugammadex (6 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Sugammadex (8 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Placebo (single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Sugammadex (1 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Sugammadex (2 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Sugammadex (4 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Sugammadex (6 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Sugammadex (8 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Period Title: Overall Study
Started 4 [1] 6 5 6 6 6 3 6 6 6 6 6 3 6 6 6 6 6
Treated 4 [2] 6 4 6 6 6 3 6 6 6 6 6 3 6 6 6 6 6
Completed 4 6 4 6 6 6 3 6 6 6 6 6 3 6 6 6 6 6
Not Completed 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Reason Not Completed
Technical Error             0             0             1             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0
[1]
N=3 randomized to Arm A. An additional N=1 (randomized to Arm C) is counted as Started in Arm A
[2]
N=1 (randomized to Arm C) received placebo, 3 min after 1.2 mg/kg Esmeron®
Arm/Group Title Arm A. Placebo; Given 3 Minutes After Esmeron® Arm B. 1 mg/kg Sugammadex; Given 3 Minutes After Esmeron® Arm C. 2 mg/kg Sugammadex; Given 3 Minutes After Esmeron® Arm D. 4 mg/kg Sugammadex; Given 3 Minutes After Esmeron® Arm E. 6 mg/kg Sugammadex; Given 3 Minutes After Esmeron® Arm F. 8 mg/kg Sugammadex; Given 3 Minutes After Esmeron® Arm G. Placebo; Given 5 Minutes After Esmeron® Arm H. 1 mg/kg Sugammadex; Given 5 Minutes After Esmeron® Arm I. 2 mg/kg Sugammadex; Given 5 Minutes After Esmeron® Arm J. 4 mg/kg Sugammadex; Given 5 Minutes After Esmeron® Arm K. 6 mg/kg Sugammadex; Given 5 Minutes After Esmeron® Arm L. 8 mg/kg Sugammadex; Given 5 Minutes After Esmeron® Arm M. Placebo; Given 15 Minutes After Esmeron® Arm N. 1 mg/kg Sugammadex; Given 15 Minutes After Esmeron® Arm O. 2 mg/kg Sugammadex; Given 15 Minutes After Esmeron® Arm P. 4 mg/kg Sugammadex; Given 15 Minutes After Esmeron® Arm Q. 6 mg/kg Sugammadex; Given 15 Minutes After Esmeron® Arm R. 8 mg/kg Sugammadex; Given 15 Minutes After Esmeron® Total
Hide Arm/Group Description Placebo (single intravenous (IV) bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Sugammadex (1 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Sugammadex (2 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Sugammadex (4 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Sugammadex (6 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Sugammadex (8 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Placebo (single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Sugammadex (1 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Sugammadex (2 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Sugammadex (4 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Sugammadex (6 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Sugammadex (8 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Placebo (single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Sugammadex (1 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Sugammadex (2 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Sugammadex (4 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Sugammadex (6 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Sugammadex (8 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Total of all reporting groups
Overall Number of Baseline Participants 4 6 4 6 6 6 3 6 6 6 6 6 3 6 6 6 6 6 98
Hide Baseline Analysis Population Description
Includes all randomized participants receiving study treatment. One participant randomized to receive 2 mg/kg Sugammadex, given 3 minutes after Esmeron® (Arm C), incorrectly received placebo. This participant is counted in the "Arm A. Placebo; given 3 minutes after Esmeron®" arm.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 6 participants 4 participants 6 participants 6 participants 6 participants 3 participants 6 participants 6 participants 6 participants 6 participants 6 participants 3 participants 6 participants 6 participants 6 participants 6 participants 6 participants 98 participants
49.8  (12.1) 35.5  (14.0) 35.8  (16.2) 41.3  (11.6) 34.3  (9.3) 39.0  (7.7) 38.7  (18.6) 35.0  (11.5) 40.5  (12.4) 40.8  (8.4) 38.7  (11.9) 31.5  (11.8) 33.0  (5.6) 48.3  (11.6) 39.8  (17.2) 41.7  (13.6) 36.0  (12.1) 40.2  (15.8) 38.9  (12.3)
[1]
Measure Analysis Population Description: Includes all randomized participants receiving study treatment. One participant randomized to receive 2 mg/kg Sugammadex, given 3 minutes after Esmeron® (Arm C), incorrectly received placebo. This participant is counted in the "Arm A. Placebo; given 3 minutes after Esmeron®" arm.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 6 participants 4 participants 6 participants 6 participants 6 participants 3 participants 6 participants 6 participants 6 participants 6 participants 6 participants 3 participants 6 participants 6 participants 6 participants 6 participants 6 participants 98 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
4
 100.0%
6
 100.0%
4
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
3
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
3
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
98
 100.0%
[1]
Measure Analysis Population Description: Includes all randomized participants receiving study treatment. One participant randomized to receive 2 mg/kg Sugammadex, given 3 minutes after Esmeron® (Arm C), incorrectly received placebo. This participant is counted in the "Arm A. Placebo; given 3 minutes after Esmeron®" arm.
1.Primary Outcome
Title Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9
Hide Description Mean time from start of study treatment administration to recovery of participant T4/T1 ratio to 0.9 was assessed through the repeated application (every 15 seconds) of an electrical stimulation protocol. Specifically, 4 electrical stimulations were applied to the ulnar nerve and the magnitude of the twitch response of the adductor pollicis muscle (i.e. thumb twitch response) was assessed. With T4 and T1 referring to the respective magnitude of the fourth and first thumb twitch during nerve stimulation, the T4/T1 ratio indicates the current degree of neuromuscular blockade (NMB) present in the participant as a decimal from 0 (loss of T4 twitch) to 1 (no NMB). Further, reduced recovery time of the T4/T1 ratio to 0.9 indicates faster recovery from NMB. Summary data, originally presented in the format of units "minutes:seconds" (mm:ss), was reformatted to be presented in the single unit of "minutes" (min).
Time Frame Up to 70 minutes following administration of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol, includes all randomized participants receiving study treatment without major protocol violations, having data available for this outcome measure.
Arm/Group Title Arm A. Placebo; Given 3 Minutes After Esmeron® Arm B. 1 mg/kg Sugammadex; Given 3 Minutes After Esmeron® Arm C. 2 mg/kg Sugammadex; Given 3 Minutes After Esmeron® Arm D. 4 mg/kg Sugammadex; Given 3 Minutes After Esmeron® Arm E. 6 mg/kg Sugammadex; Given 3 Minutes After Esmeron® Arm F. 8 mg/kg Sugammadex; Given 3 Minutes After Esmeron® Arm G. Placebo; Given 5 Minutes After Esmeron® Arm H. 1 mg/kg Sugammadex; Given 5 Minutes After Esmeron® Arm I. 2 mg/kg Sugammadex; Given 5 Minutes After Esmeron® Arm J. 4 mg/kg Sugammadex; Given 5 Minutes After Esmeron® Arm K. 6 mg/kg Sugammadex; Given 5 Minutes After Esmeron® Arm L. 8 mg/kg Sugammadex; Given 5 Minutes After Esmeron® Arm M. Placebo; Given 15 Minutes After Esmeron® Arm N. 1 mg/kg Sugammadex; Given 15 Minutes After Esmeron® Arm O. 2 mg/kg Sugammadex; Given 15 Minutes After Esmeron® Arm P. 4 mg/kg Sugammadex; Given 15 Minutes After Esmeron® Arm Q. 6 mg/kg Sugammadex; Given 15 Minutes After Esmeron® Arm R. 8 mg/kg Sugammadex; Given 15 Minutes After Esmeron®
Hide Arm/Group Description:
Placebo (single intravenous (IV) bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (1 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (2 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (4 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (6 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (8 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Placebo (single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (1 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (2 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (4 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (6 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (8 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Placebo (single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (1 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (2 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (4 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (6 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (8 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Overall Number of Participants Analyzed 3 6 3 6 5 5 3 6 6 6 6 6 3 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: minutes
52.05  (8.77) 22.73  (11.58) 4.93  (1.25) 6.25  (9.00) 1.85  (0.62) 1.83  (0.87) 51.67  (13.13) 27.35  (6.35) 8.88  (7.80) 2.28  (0.73) 2.13  (0.93) 1.45  (0.60) 35.58  (9.05) 6.53  (1.73) 2.73  (0.72) 2.05  (1.18) 2.08  (1.97) 1.35  (0.20)
2.Secondary Outcome
Title Mean Heart Rate at Baseline
Hide Description Mean heart rate at baseline was assessed. Baseline heart rate was defined as the heart rate measured under stable anesthesia prior to administration of study treatment.
Time Frame Up to 45 minutes prior to study treatment administration
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants receiving study treatment, having data available at baseline prior to administration of study treatment. One participant randomized to receive 2 mg/kg Sugammadex, given 3 minutes after Esmeron® (Arm C), incorrectly received placebo. This participant is counted in the "Arm A. Placebo; given 3 minutes after Esmeron®" arm.
Arm/Group Title Arm A. Placebo; Given 3 Minutes After Esmeron® Arm B. 1 mg/kg Sugammadex; Given 3 Minutes After Esmeron® Arm C. 2 mg/kg Sugammadex; Given 3 Minutes After Esmeron® Arm D. 4 mg/kg Sugammadex; Given 3 Minutes After Esmeron® Arm E. 6 mg/kg Sugammadex; Given 3 Minutes After Esmeron® Arm F. 8 mg/kg Sugammadex; Given 3 Minutes After Esmeron® Arm G. Placebo; Given 5 Minutes After Esmeron® Arm H. 1 mg/kg Sugammadex; Given 5 Minutes After Esmeron® Arm I. 2 mg/kg Sugammadex; Given 5 Minutes After Esmeron® Arm J. 4 mg/kg Sugammadex; Given 5 Minutes After Esmeron® Arm K. 6 mg/kg Sugammadex; Given 5 Minutes After Esmeron® Arm L. 8 mg/kg Sugammadex; Given 5 Minutes After Esmeron® Arm M. Placebo; Given 15 Minutes After Esmeron® Arm N. 1 mg/kg Sugammadex; Given 15 Minutes After Esmeron® Arm O. 2 mg/kg Sugammadex; Given 15 Minutes After Esmeron® Arm P. 4 mg/kg Sugammadex; Given 15 Minutes After Esmeron® Arm Q. 6 mg/kg Sugammadex; Given 15 Minutes After Esmeron® Arm R. 8 mg/kg Sugammadex; Given 15 Minutes After Esmeron®
Hide Arm/Group Description:
Placebo (single intravenous (IV) bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (1 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (2 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (4 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (6 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (8 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Placebo (single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (1 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (2 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (4 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (6 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (8 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Placebo (single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (1 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (2 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (4 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (6 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (8 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Overall Number of Participants Analyzed 3 5 4 6 6 6 3 6 6 6 6 6 3 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: beats per minute (bpm)
61.0  (3.6) 62.0  (4.6) 63.5  (3.9) 68.0  (11.4) 68.2  (10.8) 69.8  (18.5) 68.0  (10.6) 56.7  (10.9) 64.2  (10.5) 64.7  (7.2) 69.7  (21.0) 57.5  (4.7) 63.0  (11.8) 62.7  (8.8) 65.3  (13.5) 64.2  (8.6) 66.5  (11.7) 68.5  (9.4)
3.Secondary Outcome
Title Mean Heart Rate at 2 Minutes Following Administration of Study Treatment
Hide Description Mean heart rate at 2 minutes following administration of study treatment was assessed.
Time Frame 2 minutes following administration of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants receiving study treatment, having data available at 2 minutes following administration of study treatment. One participant randomized to receive 2 mg/kg Sugammadex at 3 minutes after Esmeron® (Arm C), incorrectly received placebo. This participant is counted in the "Arm A. Placebo; given 3 minutes after Esmeron®" arm.
Arm/Group Title Arm A. Placebo; Given 3 Minutes After Esmeron® Arm B. 1 mg/kg Sugammadex; Given 3 Minutes After Esmeron® Arm C. 2 mg/kg Sugammadex; Given 3 Minutes After Esmeron® Arm D. 4 mg/kg Sugammadex; Given 3 Minutes After Esmeron® Arm E. 6 mg/kg Sugammadex; Given 3 Minutes After Esmeron® Arm F. 8 mg/kg Sugammadex; Given 3 Minutes After Esmeron® Arm G. Placebo; Given 5 Minutes After Esmeron® Arm H. 1 mg/kg Sugammadex; Given 5 Minutes After Esmeron® Arm I. 2 mg/kg Sugammadex; Given 5 Minutes After Esmeron® Arm J. 4 mg/kg Sugammadex; Given 5 Minutes After Esmeron® Arm K. 6 mg/kg Sugammadex; Given 5 Minutes After Esmeron® Arm L. 8 mg/kg Sugammadex; Given 5 Minutes After Esmeron® Arm M. Placebo; Given 15 Minutes After Esmeron® Arm N. 1 mg/kg Sugammadex; Given 15 Minutes After Esmeron® Arm O. 2 mg/kg Sugammadex; Given 15 Minutes After Esmeron® Arm P. 4 mg/kg Sugammadex; Given 15 Minutes After Esmeron® Arm Q. 6 mg/kg Sugammadex; Given 15 Minutes After Esmeron® Arm R. 8 mg/kg Sugammadex; Given 15 Minutes After Esmeron®
Hide Arm/Group Description:
Placebo (single intravenous (IV) bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (1 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (2 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (4 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (6 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (8 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Placebo (single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (1 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (2 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (4 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (6 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (8 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Placebo (single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (1 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (2 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (4 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (6 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (8 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Overall Number of Participants Analyzed 3 5 4 6 5 6 3 6 6 6 5 6 2 5 5 6 5 6
Mean (Standard Deviation)
Unit of Measure: bpm
76.7  (18.6) 73.0  (15.0) 84.5  (12.0) 72.7  (12.1) 86.2  (15.5) 74.8  (17.7) 84.0  (15.1) 61.3  (11.2) 70.8  (13.7) 66.2  (9.8) 69.8  (21.3) 67.8  (10.2) 59.0  (1.4) 71.2  (12.9) 77.2  (16.5) 62.8  (5.0) 65.4  (14.7) 64.3  (5.4)
4.Secondary Outcome
Title Mean Heart Rate at 30 Minutes Following Administration of Study Treatment
Hide Description Mean heart rate at 30 minutes following administration of study treatment was assessed.
Time Frame 30 minutes following administration of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants receiving study treatment, having data available at 30 minutes following administration of study treatment. One participant randomized to receive 2 mg/kg Sugammadex at 3 minutes after Esmeron® (Arm C), incorrectly received placebo. This participant is counted in the "Arm A. Placebo; given 3 minutes after Esmeron®" arm.
Arm/Group Title Arm A. Placebo; Given 3 Minutes After Esmeron® Arm B. 1 mg/kg Sugammadex; Given 3 Minutes After Esmeron® Arm C. 2 mg/kg Sugammadex; Given 3 Minutes After Esmeron® Arm D. 4 mg/kg Sugammadex; Given 3 Minutes After Esmeron® Arm E. 6 mg/kg Sugammadex; Given 3 Minutes After Esmeron® Arm F. 8 mg/kg Sugammadex; Given 3 Minutes After Esmeron® Arm G. Placebo; Given 5 Minutes After Esmeron® Arm H. 1 mg/kg Sugammadex; Given 5 Minutes After Esmeron® Arm I. 2 mg/kg Sugammadex; Given 5 Minutes After Esmeron® Arm J. 4 mg/kg Sugammadex; Given 5 Minutes After Esmeron® Arm K. 6 mg/kg Sugammadex; Given 5 Minutes After Esmeron® Arm L. 8 mg/kg Sugammadex; Given 5 Minutes After Esmeron® Arm M. Placebo; Given 15 Minutes After Esmeron® Arm N. 1 mg/kg Sugammadex; Given 15 Minutes After Esmeron® Arm O. 2 mg/kg Sugammadex; Given 15 Minutes After Esmeron® Arm P. 4 mg/kg Sugammadex; Given 15 Minutes After Esmeron® Arm Q. 6 mg/kg Sugammadex; Given 15 Minutes After Esmeron® Arm R. 8 mg/kg Sugammadex; Given 15 Minutes After Esmeron®
Hide Arm/Group Description:
Placebo (single intravenous (IV) bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (1 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (2 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (4 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (6 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (8 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Placebo (single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (1 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (2 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (4 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (6 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (8 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Placebo (single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (1 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (2 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (4 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (6 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (8 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Overall Number of Participants Analyzed 4 4 4 6 6 5 3 6 6 6 6 6 3 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: bpm
77.8  (8.6) 62.0  (2.8) 72.0  (7.8) 72.5  (9.6) 76.7  (11.2) 66.6  (15.2) 77.3  (9.5) 63.0  (12.6) 69.7  (11.4) 72.5  (17.1) 66.5  (23.9) 60.0  (4.0) 65.7  (16.8) 66.8  (11.5) 65.3  (10.8) 63.5  (7.9) 64.7  (14.3) 66.0  (5.8)
5.Secondary Outcome
Title Mean Corrected QT Interval (QTc) at Baseline
Hide Description Mean QTc interval at baseline was assessed. Baseline QTc interval was defined as the QTc interval measured under stable anesthesia prior to administration of study treatment. The baseline QTc interval is corrected for participant heart rate at baseline prior to study treatment administration using Fridericia's correction, where QTc = QT interval/(RR interval)^(1/3). RR interval = 60/heart rate.
Time Frame Up to 45 minutes prior to study treatment administration
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants receiving study treatment, having data available at baseline prior to administration of study treatment. One participant randomized to receive 2 mg/kg Sugammadex, given 3 minutes after Esmeron® (Arm C), incorrectly received placebo. This participant is counted in the "Arm A. Placebo; given 3 minutes after Esmeron®" arm.
Arm/Group Title Arm A. Placebo; Given 3 Minutes After Esmeron® Arm B. 1 mg/kg Sugammadex; Given 3 Minutes After Esmeron® Arm C. 2 mg/kg Sugammadex; Given 3 Minutes After Esmeron® Arm D. 4 mg/kg Sugammadex; Given 3 Minutes After Esmeron® Arm E. 6 mg/kg Sugammadex; Given 3 Minutes After Esmeron® Arm F. 8 mg/kg Sugammadex; Given 3 Minutes After Esmeron® Arm G. Placebo; Given 5 Minutes After Esmeron® Arm H. 1 mg/kg Sugammadex; Given 5 Minutes After Esmeron® Arm I. 2 mg/kg Sugammadex; Given 5 Minutes After Esmeron® Arm J. 4 mg/kg Sugammadex; Given 5 Minutes After Esmeron® Arm K. 6 mg/kg Sugammadex; Given 5 Minutes After Esmeron® Arm L. 8 mg/kg Sugammadex; Given 5 Minutes After Esmeron® Arm M. Placebo; Given 15 Minutes After Esmeron® Arm N. 1 mg/kg Sugammadex; Given 15 Minutes After Esmeron® Arm O. 2 mg/kg Sugammadex; Given 15 Minutes After Esmeron® Arm P. 4 mg/kg Sugammadex; Given 15 Minutes After Esmeron® Arm Q. 6 mg/kg Sugammadex; Given 15 Minutes After Esmeron® Arm R. 8 mg/kg Sugammadex; Given 15 Minutes After Esmeron®
Hide Arm/Group Description:
Placebo (single intravenous (IV) bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (1 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (2 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (4 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (6 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (8 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Placebo (single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (1 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (2 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (4 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (6 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (8 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Placebo (single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (1 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (2 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (4 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (6 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (8 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Overall Number of Participants Analyzed 3 5 4 6 6 6 3 6 6 6 6 6 3 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: milliseconds (msec)
418  (2.5) 396  (11.3) 418  (17.8) 404  (20.7) 417  (13.1) 416  (20.4) 400  (23.9) 415  (19.6) 405  (15.7) 416  (21.7) 408  (22.2) 411  (13.9) 392  (13.9) 410  (11.8) 398  (14.5) 398  (23.6) 398  (24.8) 406  (25.4)
6.Secondary Outcome
Title Mean Corrected QT Interval (QTc) at 2 Minutes Following Administration of Study Treatment
Hide Description Mean QTc interval at 2 minutes following administration of study treatment was assessed. The QTc interval is corrected for participant heart rate at 2 minutes following study treatment administration using Fridericia's correction, where QTc = QT interval/(RR interval)^(1/3). RR interval = 60/heart rate.
Time Frame 2 minutes following administration of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants receiving study treatment, having data available at 2 minutes following administration of study treatment. One participant randomized to receive 2 mg/kg Sugammadex at 3 minutes after Esmeron® (Arm C), incorrectly received placebo. This participant is counted in the "Arm A. Placebo; given 3 minutes after Esmeron®" arm.
Arm/Group Title Arm A. Placebo; Given 3 Minutes After Esmeron® Arm B. 1 mg/kg Sugammadex; Given 3 Minutes After Esmeron® Arm C. 2 mg/kg Sugammadex; Given 3 Minutes After Esmeron® Arm D. 4 mg/kg Sugammadex; Given 3 Minutes After Esmeron® Arm E. 6 mg/kg Sugammadex; Given 3 Minutes After Esmeron® Arm F. 8 mg/kg Sugammadex; Given 3 Minutes After Esmeron® Arm G. Placebo; Given 5 Minutes After Esmeron® Arm H. 1 mg/kg Sugammadex; Given 5 Minutes After Esmeron® Arm I. 2 mg/kg Sugammadex; Given 5 Minutes After Esmeron® Arm J. 4 mg/kg Sugammadex; Given 5 Minutes After Esmeron® Arm K. 6 mg/kg Sugammadex; Given 5 Minutes After Esmeron® Arm L. 8 mg/kg Sugammadex; Given 5 Minutes After Esmeron® Arm M. Placebo; Given 15 Minutes After Esmeron® Arm N. 1 mg/kg Sugammadex; Given 15 Minutes After Esmeron® Arm O. 2 mg/kg Sugammadex; Given 15 Minutes After Esmeron® Arm P. 4 mg/kg Sugammadex; Given 15 Minutes After Esmeron® Arm Q. 6 mg/kg Sugammadex; Given 15 Minutes After Esmeron® Arm R. 8 mg/kg Sugammadex; Given 15 Minutes After Esmeron®
Hide Arm/Group Description:
Placebo (single intravenous (IV) bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (1 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (2 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (4 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (6 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (8 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Placebo (single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (1 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (2 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (4 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (6 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (8 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Placebo (single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (1 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (2 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (4 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (6 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (8 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Overall Number of Participants Analyzed 3 5 4 6 5 6 3 6 6 6 5 6 2 5 5 6 5 6
Mean (Standard Deviation)
Unit of Measure: msec
420  (13.7) 406  (11.8) 422  (17.0) 406  (24.7) 427  (10.5) 416  (14.5) 400  (27.5) 420  (16.3) 412  (16.6) 419  (20.3) 410  (24.9) 416  (20.2) 401  (4.2) 419  (15.6) 406  (12.9) 416  (26.5) 410  (31.8) 416  (16.8)
7.Secondary Outcome
Title Mean Corrected QT Interval (QTc) at 30 Minutes Following Administration of Study Treatment
Hide Description Mean QTc interval at 30 minutes following administration of study treatment was assessed. The QTc interval is corrected for participant heart rate at 30 minutes following study treatment administration using Fridericia's correction, where QTc = QT interval/(RR interval)^(1/3). RR interval = 60/heart rate.
Time Frame 30 minutes following administration of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants receiving study treatment, having data available at 30 minutes following administration of study treatment. One participant randomized to receive 2 mg/kg Sugammadex at 3 minutes after Esmeron® (Arm C), incorrectly received placebo. This participant is counted in the "Arm A. Placebo; given 3 minutes after Esmeron®" arm.
Arm/Group Title Arm A. Placebo; Given 3 Minutes After Esmeron® Arm B. 1 mg/kg Sugammadex; Given 3 Minutes After Esmeron® Arm C. 2 mg/kg Sugammadex; Given 3 Minutes After Esmeron® Arm D. 4 mg/kg Sugammadex; Given 3 Minutes After Esmeron® Arm E. 6 mg/kg Sugammadex; Given 3 Minutes After Esmeron® Arm F. 8 mg/kg Sugammadex; Given 3 Minutes After Esmeron® Arm G. Placebo; Given 5 Minutes After Esmeron® Arm H. 1 mg/kg Sugammadex; Given 5 Minutes After Esmeron® Arm I. 2 mg/kg Sugammadex; Given 5 Minutes After Esmeron® Arm J. 4 mg/kg Sugammadex; Given 5 Minutes After Esmeron® Arm K. 6 mg/kg Sugammadex; Given 5 Minutes After Esmeron® Arm L. 8 mg/kg Sugammadex; Given 5 Minutes After Esmeron® Arm M. Placebo; Given 15 Minutes After Esmeron® Arm N. 1 mg/kg Sugammadex; Given 15 Minutes After Esmeron® Arm O. 2 mg/kg Sugammadex; Given 15 Minutes After Esmeron® Arm P. 4 mg/kg Sugammadex; Given 15 Minutes After Esmeron® Arm Q. 6 mg/kg Sugammadex; Given 15 Minutes After Esmeron® Arm R. 8 mg/kg Sugammadex; Given 15 Minutes After Esmeron®
Hide Arm/Group Description:
Placebo (single intravenous (IV) bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (1 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (2 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (4 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (6 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (8 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Placebo (single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (1 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (2 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (4 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (6 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (8 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Placebo (single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (1 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (2 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (4 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (6 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (8 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Overall Number of Participants Analyzed 4 4 4 6 6 5 3 6 6 6 6 6 3 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: msec
418  (11.6) 416  (17.6) 427  (13.2) 415  (21.7) 433  (21.6) 424  (27.0) 392  (21.1) 420  (21.3) 425  (19.6) 413  (21.9) 400  (27.4) 422  (14.4) 400  (6.8) 418  (18.5) 408  (14.6) 421  (33.8) 411  (25.3) 418  (22.0)
8.Secondary Outcome
Title Number of Participants Experiencing an Adverse Event
Hide Description The number of participants experiencing an adverse event (AE) was assessed. An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product.
Time Frame Up to 7 days following administration of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all randomized participants receiving study treatment. One participant randomized to receive 2 mg/kg Sugammadex, given 3 minutes after Esmeron® (Arm C), incorrectly received placebo. This participant is counted in the "Arm A. Placebo; given 3 minutes after Esmeron®" arm.
Arm/Group Title Arm A. Placebo; Given 3 Minutes After Esmeron® Arm B. 1 mg/kg Sugammadex; Given 3 Minutes After Esmeron® Arm C. 2 mg/kg Sugammadex; Given 3 Minutes After Esmeron® Arm D. 4 mg/kg Sugammadex; Given 3 Minutes After Esmeron® Arm E. 6 mg/kg Sugammadex; Given 3 Minutes After Esmeron® Arm F. 8 mg/kg Sugammadex; Given 3 Minutes After Esmeron® Arm G. Placebo; Given 5 Minutes After Esmeron® Arm H. 1 mg/kg Sugammadex; Given 5 Minutes After Esmeron® Arm I. 2 mg/kg Sugammadex; Given 5 Minutes After Esmeron® Arm J. 4 mg/kg Sugammadex; Given 5 Minutes After Esmeron® Arm K. 6 mg/kg Sugammadex; Given 5 Minutes After Esmeron® Arm L. 8 mg/kg Sugammadex; Given 5 Minutes After Esmeron® Arm M. Placebo; Given 15 Minutes After Esmeron® Arm N. 1 mg/kg Sugammadex; Given 15 Minutes After Esmeron® Arm O. 2 mg/kg Sugammadex; Given 15 Minutes After Esmeron® Arm P. 4 mg/kg Sugammadex; Given 15 Minutes After Esmeron® Arm Q. 6 mg/kg Sugammadex; Given 15 Minutes After Esmeron® Arm R. 8 mg/kg Sugammadex; Given 15 Minutes After Esmeron®
Hide Arm/Group Description:
Placebo (single intravenous (IV) bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (1 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (2 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (4 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (6 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (8 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Placebo (single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (1 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (2 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (4 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (6 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (8 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Placebo (single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (1 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (2 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (4 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (6 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Sugammadex (8 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Overall Number of Participants Analyzed 4 6 4 6 6 6 3 6 6 6 6 6 3 6 6 6 6 6
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
5
  83.3%
1
  25.0%
4
  66.7%
4
  66.7%
5
  83.3%
2
  66.7%
2
  33.3%
1
  16.7%
3
  50.0%
2
  33.3%
2
  33.3%
0
   0.0%
4
  66.7%
4
  66.7%
1
  16.7%
1
  16.7%
3
  50.0%
Time Frame Up to 7 days following administration of study treatment
Adverse Event Reporting Description Includes all randomized participants receiving study treatment. One participant randomized to receive 2 mg/kg Sugammadex given 3 minutes after Esmeron® (Arm C), incorrectly received placebo. This participant is counted in the "Arm A. Placebo; given 3 minutes after Esmeron®" arm.
 
Arm/Group Title Arm A. Placebo; Given 3 Minutes After Esmeron Arm B. 1 mg/kg Sugammadex; Given 3 Minutes After Esmeron Arm C. 2 mg/kg Sugammadex; Given 3 Minutes After Esmeron Arm D. 4 mg/kg Sugammadex; Given 3 Minutes After Esmeron Arm E. 6 mg/kg Sugammadex; Given 3 Minutes After Esmeron Arm F. 8 mg/kg Sugammadex; Given 3 Minutes After Esmeron Arm G. Placebo; Given 5 Minutes After Esmeron Arm H. 1 mg/kg Sugammadex; Given 5 Minutes After Esmeron Arm I. 2 mg/kg Sugammadex; Given 5 Minutes After Esmeron Arm J. 4 mg/kg Sugammadex; Given 5 Minutes After Esmeron Arm K. 6 mg/kg Sugammadex; Given 5 Minutes After Esmeron Arm L. 8 mg/kg Sugammadex; Given 5 Minutes After Esmeron Arm M. Placebo; Given 15 Minutes After Esmeron Arm N. 1 mg/kg Sugammadex; Given 15 Minutes After Esmeron Arm O. 2 mg/kg Sugammadex; Given 15 Minutes After Esmeron Arm P. 4 mg/kg Sugammadex; Given 15 Minutes After Esmeron Arm Q. 6 mg/kg Sugammadex; Given 15 Minutes After Esmeron Arm R. 8 mg/kg Sugammadex; Given 15 Minutes After Esmeron
Hide Arm/Group Description Placebo (single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Sugammadex (1 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Sugammadex (2 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Sugammadex (4 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Sugammadex (6 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Sugammadex (8 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Placebo (single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Sugammadex (1 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Sugammadex (2 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Sugammadex (4 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Sugammadex (6 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Sugammadex (8 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Placebo (single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Sugammadex (1 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Sugammadex (2 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Sugammadex (4 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Sugammadex (6 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. Sugammadex (8 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
All-Cause Mortality
Arm A. Placebo; Given 3 Minutes After Esmeron Arm B. 1 mg/kg Sugammadex; Given 3 Minutes After Esmeron Arm C. 2 mg/kg Sugammadex; Given 3 Minutes After Esmeron Arm D. 4 mg/kg Sugammadex; Given 3 Minutes After Esmeron Arm E. 6 mg/kg Sugammadex; Given 3 Minutes After Esmeron Arm F. 8 mg/kg Sugammadex; Given 3 Minutes After Esmeron Arm G. Placebo; Given 5 Minutes After Esmeron Arm H. 1 mg/kg Sugammadex; Given 5 Minutes After Esmeron Arm I. 2 mg/kg Sugammadex; Given 5 Minutes After Esmeron Arm J. 4 mg/kg Sugammadex; Given 5 Minutes After Esmeron Arm K. 6 mg/kg Sugammadex; Given 5 Minutes After Esmeron Arm L. 8 mg/kg Sugammadex; Given 5 Minutes After Esmeron Arm M. Placebo; Given 15 Minutes After Esmeron Arm N. 1 mg/kg Sugammadex; Given 15 Minutes After Esmeron Arm O. 2 mg/kg Sugammadex; Given 15 Minutes After Esmeron Arm P. 4 mg/kg Sugammadex; Given 15 Minutes After Esmeron Arm Q. 6 mg/kg Sugammadex; Given 15 Minutes After Esmeron Arm R. 8 mg/kg Sugammadex; Given 15 Minutes After Esmeron
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)      0/6 (0.00%)      0/4 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/3 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/3 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)    
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Arm A. Placebo; Given 3 Minutes After Esmeron Arm B. 1 mg/kg Sugammadex; Given 3 Minutes After Esmeron Arm C. 2 mg/kg Sugammadex; Given 3 Minutes After Esmeron Arm D. 4 mg/kg Sugammadex; Given 3 Minutes After Esmeron Arm E. 6 mg/kg Sugammadex; Given 3 Minutes After Esmeron Arm F. 8 mg/kg Sugammadex; Given 3 Minutes After Esmeron Arm G. Placebo; Given 5 Minutes After Esmeron Arm H. 1 mg/kg Sugammadex; Given 5 Minutes After Esmeron Arm I. 2 mg/kg Sugammadex; Given 5 Minutes After Esmeron Arm J. 4 mg/kg Sugammadex; Given 5 Minutes After Esmeron Arm K. 6 mg/kg Sugammadex; Given 5 Minutes After Esmeron Arm L. 8 mg/kg Sugammadex; Given 5 Minutes After Esmeron Arm M. Placebo; Given 15 Minutes After Esmeron Arm N. 1 mg/kg Sugammadex; Given 15 Minutes After Esmeron Arm O. 2 mg/kg Sugammadex; Given 15 Minutes After Esmeron Arm P. 4 mg/kg Sugammadex; Given 15 Minutes After Esmeron Arm Q. 6 mg/kg Sugammadex; Given 15 Minutes After Esmeron Arm R. 8 mg/kg Sugammadex; Given 15 Minutes After Esmeron
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/4 (0.00%)      0/6 (0.00%)      0/4 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/3 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/3 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)    
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Frequency Threshold for Reporting Other Adverse Events 5%
Arm A. Placebo; Given 3 Minutes After Esmeron Arm B. 1 mg/kg Sugammadex; Given 3 Minutes After Esmeron Arm C. 2 mg/kg Sugammadex; Given 3 Minutes After Esmeron Arm D. 4 mg/kg Sugammadex; Given 3 Minutes After Esmeron Arm E. 6 mg/kg Sugammadex; Given 3 Minutes After Esmeron Arm F. 8 mg/kg Sugammadex; Given 3 Minutes After Esmeron Arm G. Placebo; Given 5 Minutes After Esmeron Arm H. 1 mg/kg Sugammadex; Given 5 Minutes After Esmeron Arm I. 2 mg/kg Sugammadex; Given 5 Minutes After Esmeron Arm J. 4 mg/kg Sugammadex; Given 5 Minutes After Esmeron Arm K. 6 mg/kg Sugammadex; Given 5 Minutes After Esmeron Arm L. 8 mg/kg Sugammadex; Given 5 Minutes After Esmeron Arm M. Placebo; Given 15 Minutes After Esmeron Arm N. 1 mg/kg Sugammadex; Given 15 Minutes After Esmeron Arm O. 2 mg/kg Sugammadex; Given 15 Minutes After Esmeron Arm P. 4 mg/kg Sugammadex; Given 15 Minutes After Esmeron Arm Q. 6 mg/kg Sugammadex; Given 15 Minutes After Esmeron Arm R. 8 mg/kg Sugammadex; Given 15 Minutes After Esmeron
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/4 (0.00%)      5/6 (83.33%)      1/4 (25.00%)      4/6 (66.67%)      4/6 (66.67%)      5/6 (83.33%)      2/3 (66.67%)      2/6 (33.33%)      1/6 (16.67%)      3/6 (50.00%)      2/6 (33.33%)      2/6 (33.33%)      0/3 (0.00%)      4/6 (66.67%)      4/6 (66.67%)      1/6 (16.67%)      1/6 (16.67%)      3/6 (50.00%)    
Cardiac disorders                                     
Bradycardia  1  0/4 (0.00%)  0 1/6 (16.67%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Tachycardia  1  0/4 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  2 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Eye disorders                                     
Keratitis  1  0/4 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Gastrointestinal disorders                                     
Diarrhoea  1  0/4 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Nausea  1  0/4 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Salivary hypersecretion  1  0/4 (0.00%)  0 1/6 (16.67%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Vomiting  1  0/4 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
General disorders                                     
Chills  1  0/4 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1 0/6 (0.00%)  0 1/6 (16.67%)  1
Pyrexia  1  0/4 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Therapeutic response decreased  1  0/4 (0.00%)  0 3/6 (50.00%)  4 1/4 (25.00%)  1 1/6 (16.67%)  2 1/6 (16.67%)  3 4/6 (66.67%)  6 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 2/6 (33.33%)  2 2/6 (33.33%)  3 0/6 (0.00%)  0 1/6 (16.67%)  1 2/6 (33.33%)  2
Injury, poisoning and procedural complications                                     
Delayed recovery from anaesthesia  1  0/4 (0.00%)  0 2/6 (33.33%)  2 0/4 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Fall  1  0/4 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Procedural pain  1  0/4 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Investigations                                     
Blood urea increased  1  0/4 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Urine analysis abnormal  1  0/4 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 2/6 (33.33%)  3 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Nervous system disorders                                     
Dizziness  1  0/4 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Hypoaesthesia  1  0/4 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Renal and urinary disorders                                     
Albuminuria  1  0/4 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Urinary retention  1  0/4 (0.00%)  0 2/6 (33.33%)  2 0/4 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1 1/3 (33.33%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                                     
Bradypnoea  1  0/4 (0.00%)  0 3/6 (50.00%)  3 0/4 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  2 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Cough  1  0/4 (0.00%)  0 1/6 (16.67%)  2 0/4 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1 2/6 (33.33%)  3 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 2/6 (33.33%)  2 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  2
Epistaxis  1  0/4 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Hypoventilation  1  0/4 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Respiratory depression  1  0/4 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 2/6 (33.33%)  2 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Vascular disorders                                     
Haemorrhage  1  0/4 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Hypertension  1  0/4 (0.00%)  0 1/6 (16.67%)  1 0/4 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Hypotension  1  0/4 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Sponsor recognizes the right of the investigators to publish, but all publications must be based on data validated by the Sponsor. Any such scientific paper, presentation, or other communication concerning the clinical trial described in this protocol will first be submitted to the Sponsor, at least six weeks ahead of estimated publication or presentation, for written consent, which shall not be withheld unreasonably.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT03519854     History of Changes
Other Study ID Numbers: P05940
MK-8616-020 ( Other Identifier: Merck Protocol Number )
19.4.202 ( Other Identifier: Organon Protocol Number )
First Submitted: May 8, 2018
First Posted: May 9, 2018
Results First Submitted: August 28, 2018
Results First Posted: February 1, 2019
Last Update Posted: April 2, 2019