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Comparison of Sugammadex (Org 25969) With Neostigmine as Reversal Agents for Rocuronium or Vecuronium at Reappearance of T2 (P05960)

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ClinicalTrials.gov Identifier: NCT00451217
Recruitment Status : Completed
First Posted : March 23, 2007
Results First Posted : February 18, 2019
Last Update Posted : March 4, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Anesthesia, General
Interventions Drug: Sugammadex
Drug: Neostigmine
Enrollment 198
Recruitment Details Participants who had a surgical procedure using a general anesthesia of rocuronium or vecuronium for endotracheal intubation and maintenance of neuromuscular block were enrolled in this study.
Pre-assignment Details  
Arm/Group Title Rocuronium + Sugammadex Rocuronium + Neostigmine Vecuronium + Sugammadex Vecuronium + Neostigmine
Hide Arm/Group Description After the last dose of rocuronium, at reappearance of second twitch (T2), a dose of 2.0 mg/kg sugammadex was administered After the last dose of rocuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered After the last dose of vecuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered After the last dose of vecuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered
Period Title: Overall Study
Started 49 49 51 49
Treated 48 48 48 45
Completed 47 47 47 44
Not Completed 2 2 4 5
Reason Not Completed
Lost to Follow-up             0             1             1             1
Withdrawal by Subject             1             0             0             0
Not Treated             1             1             3             4
Arm/Group Title Rocuronium + Sugammadex Rocuronium + Neostigmine Vecuronium + Sugammadex Vecuronium + Neostigmine Total
Hide Arm/Group Description After the last dose of rocuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered After the last dose of rocuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered After the last dose of vecuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered After the last dose of vecuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered Total of all reporting groups
Overall Number of Baseline Participants 48 48 48 45 189
Hide Baseline Analysis Population Description
All Participants As Treated
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 48 participants 48 participants 48 participants 45 participants 189 participants
51  (16) 48  (14) 49  (16) 50  (15) 49  (15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants 48 participants 48 participants 45 participants 189 participants
Female
17
  35.4%
24
  50.0%
22
  45.8%
24
  53.3%
87
  46.0%
Male
31
  64.6%
24
  50.0%
26
  54.2%
21
  46.7%
102
  54.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants 48 participants 48 participants 45 participants 189 participants
Hispanic or Latino
5
  10.4%
9
  18.8%
7
  14.6%
8
  17.8%
29
  15.3%
Not Hispanic or Latino
43
  89.6%
39
  81.3%
41
  85.4%
37
  82.2%
160
  84.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants 48 participants 48 participants 45 participants 189 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   2.1%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.5%
White
46
  95.8%
48
 100.0%
48
 100.0%
45
 100.0%
187
  98.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   2.1%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.5%
1.Primary Outcome
Title Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9.
Hide Description Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from neuromuscular blockade (NMB). In this study, twitch responses were recorded until the T4/T1 Ratio reached >= 0.9, the minimum acceptable ratio that indicated recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.9 indicates a faster recovery from NMB.
Time Frame Day 1: From start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.9
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received sugammadex or neostigmine and had at least one efficacy measurement. Imputed recovery times were used in cases of missing times.
Arm/Group Title Rocuronium + Sugammadex Rocuronium + Neostigmine Vecuronium + Sugammadex Vecuronium + Neostigmine
Hide Arm/Group Description:
After the last dose of rocuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered
After the last dose of rocuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered
After the last dose of vecuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered
After the last dose of vecuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered
Overall Number of Participants Analyzed 48 48 48 45
Mean (Standard Deviation)
Unit of Measure: Minutes
1.62  (0.83) 26.78  (24.60) 4.47  (9.28) 23.43  (18.53)
2.Secondary Outcome
Title Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.7
Hide Description Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.7 indicates a faster recovery from NMB.
Time Frame Day 1: From start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.7
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received sugammadex or neostigmine and had at least one efficacy measurement. Imputed recovery times were used in cases of missing times.
Arm/Group Title Rocuronium + Sugammadex Rocuronium + Neostigmine Vecuronium + Sugammadex Vecuronium + Neostigmine
Hide Arm/Group Description:
After the last dose of rocuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered
After the last dose of rocuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered
After the last dose of vecuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered
After the last dose of vecuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered
Overall Number of Participants Analyzed 48 48 48 45
Mean (Standard Deviation)
Unit of Measure: Minutes
1.17  (0.40) 9.60  (8.23) 1.68  (0.57) 9.52  (10.15)
3.Secondary Outcome
Title Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.8
Hide Description Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.8 indicates a faster recovery from NMB.
Time Frame Day 1: From start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.8
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received sugammadex or neostigmine and had at least one efficacy measurement. Imputed recovery times were used in cases of missing times.
Arm/Group Title Rocuronium + Sugammadex Rocuronium + Neostigmine Vecuronium + Sugammadex Vecuronium + Neostigmine
Hide Arm/Group Description:
After the last dose of rocuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered
After the last dose of rocuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered
After the last dose of vecuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered
After the last dose of vecuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered
Overall Number of Participants Analyzed 48 48 48 45
Mean (Standard Deviation)
Unit of Measure: Minutes
1.32  (0.48) 15.32  (14.38) 2.12  (0.87) 15.33  (13.37)
4.Secondary Outcome
Title Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Transfer to the Recovery Room After Extubation
Hide Description After anesthesia and prior to transfer to the recovery room after extubation, neuromuscular recovery was assessed by monitoring every 15 minutes the following clinical signs of recovery: level of consciousness (i.e., awake and oriented, arousable with minimal stimulation, responsive only to tactile stimulation); 5-second head lift test (ability to lift the head for 5 seconds); and general muscle weakness
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received sugammadex or neostigmine and had at least one efficacy measurement.
Arm/Group Title Rocuronium + Sugammadex Rocuronium + Neostigmine Vecuronium + Sugammadex Vecuronium + Neostigmine
Hide Arm/Group Description:
After the last dose of rocuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered
After the last dose of rocuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered
After the last dose of vecuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered
After the last dose of vecuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered
Overall Number of Participants Analyzed 48 48 48 45
Measure Type: Count of Participants
Unit of Measure: Participants
Consciousness: Awake and oriented
30
  62.5%
35
  72.9%
29
  60.4%
26
  57.8%
Consciousness: Arousable with minimal stimulation
16
  33.3%
13
  27.1%
17
  35.4%
14
  31.1%
Consciousness: Responsive only to tactile stimuli
2
   4.2%
0
   0.0%
2
   4.2%
5
  11.1%
Able to perform the 5 second head lift
38
  79.2%
37
  77.1%
40
  83.3%
32
  71.1%
Has general muscle weakness
3
   6.3%
9
  18.8%
4
   8.3%
6
  13.3%
5.Secondary Outcome
Title Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Discharge From the Recovery Room
Hide Description Just prior to discharge from the recovery room, neuromuscular recovery was assessed by monitoring every 15 minutes the following clinical signs of recovery: level of consciousness (i.e., awake and oriented, arousable with minimal stimulation, responsive only to tactile stimulation); 5-second head lift test (ability to lift the head for 5 seconds); and general muscle weakness
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received sugammadex or neostigmine and had at least one efficacy measurement. One participant from the Rocuronium + Sugammadex treatment group, and one participant from the Vecuronium + Neostigmine treatment group were not analyzed.
Arm/Group Title Rocuronium + Sugammadex Rocuronium + Neostigmine Vecuronium + Sugammadex Vecuronium + Neostigmine
Hide Arm/Group Description:
After the last dose of rocuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered
After the last dose of rocuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered
After the last dose of vecuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered
After the last dose of vecuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered
Overall Number of Participants Analyzed 47 48 48 44
Measure Type: Count of Participants
Unit of Measure: Participants
Consciousness: Awake and oriented
46
  97.9%
48
 100.0%
48
 100.0%
43
  97.7%
Consciousness: Arousable with minimal stimulation
1
   2.1%
0
   0.0%
0
   0.0%
1
   2.3%
Consciousness: Responsive only to tactile stimuli
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Able to perform the 5 second head lift
47
 100.0%
48
 100.0%
48
 100.0%
44
 100.0%
Has general muscle weakness
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Time Frame Up to 7 days after sugammadex or neostigmine treatment
Adverse Event Reporting Description All participants as treated
 
Arm/Group Title Rocuronium + Sugammadex Rocuronium + Neostigmine Vecuronium + Sugammadex Vecuronium + Neostigmine
Hide Arm/Group Description After the last dose of rocuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered After the last dose of rocuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered After the last dose of vecuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered After the last dose of vecuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered
All-Cause Mortality
Rocuronium + Sugammadex Rocuronium + Neostigmine Vecuronium + Sugammadex Vecuronium + Neostigmine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/48 (0.00%)      0/48 (0.00%)      0/48 (0.00%)      0/45 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Rocuronium + Sugammadex Rocuronium + Neostigmine Vecuronium + Sugammadex Vecuronium + Neostigmine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/48 (4.17%)      3/48 (6.25%)      0/48 (0.00%)      0/45 (0.00%)    
Gastrointestinal disorders         
Subileus  1  0/48 (0.00%)  0 1/48 (2.08%)  1 0/48 (0.00%)  0 0/45 (0.00%)  0
Infections and infestations         
Postoperative infection  1  0/48 (0.00%)  0 1/48 (2.08%)  1 0/48 (0.00%)  0 0/45 (0.00%)  0
Injury, poisoning and procedural complications         
Post procedural haemorrhage  1  2/48 (4.17%)  2 0/48 (0.00%)  0 0/48 (0.00%)  0 0/45 (0.00%)  0
Procedural complication  1  0/48 (0.00%)  0 1/48 (2.08%)  1 0/48 (0.00%)  0 0/45 (0.00%)  0
Vascular disorders         
Peripheral arterial occlusive disease  1  0/48 (0.00%)  0 1/48 (2.08%)  1 0/48 (0.00%)  0 0/45 (0.00%)  0
Peripheral ischaemia  1  0/48 (0.00%)  0 1/48 (2.08%)  1 0/48 (0.00%)  0 0/45 (0.00%)  0
1
Term from vocabulary, MedDRA 9.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Rocuronium + Sugammadex Rocuronium + Neostigmine Vecuronium + Sugammadex Vecuronium + Neostigmine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   37/48 (77.08%)      40/48 (83.33%)      32/48 (66.67%)      35/45 (77.78%)    
Gastrointestinal disorders         
Constipation  1  0/48 (0.00%)  0 6/48 (12.50%)  6 2/48 (4.17%)  2 3/45 (6.67%)  3
Dry mouth  1  3/48 (6.25%)  3 5/48 (10.42%)  5 1/48 (2.08%)  1 7/45 (15.56%)  7
Nausea  1  12/48 (25.00%)  13 14/48 (29.17%)  17 13/48 (27.08%)  13 16/45 (35.56%)  19
Vomiting  1  9/48 (18.75%)  9 6/48 (12.50%)  6 5/48 (10.42%)  6 5/45 (11.11%)  6
General disorders         
Chills  1  2/48 (4.17%)  2 4/48 (8.33%)  4 4/48 (8.33%)  4 2/45 (4.44%)  2
Pain  1  11/48 (22.92%)  12 8/48 (16.67%)  8 6/48 (12.50%)  7 5/45 (11.11%)  5
Injury, poisoning and procedural complications         
Airway complication of anaesthesia  1  1/48 (2.08%)  1 1/48 (2.08%)  1 1/48 (2.08%)  2 3/45 (6.67%)  3
Neuromuscular block prolonged  1  0/48 (0.00%)  0 0/48 (0.00%)  0 0/48 (0.00%)  0 4/45 (8.89%)  4
Post procedural nausea  1  1/48 (2.08%)  1 3/48 (6.25%)  3 1/48 (2.08%)  1 3/45 (6.67%)  4
Post procedural vomiting  1  0/48 (0.00%)  0 1/48 (2.08%)  1 0/48 (0.00%)  0 3/45 (6.67%)  4
Procedural complication  1  1/48 (2.08%)  1 1/48 (2.08%)  1 1/48 (2.08%)  1 4/45 (8.89%)  5
Procedural hypertension  1  4/48 (8.33%)  5 3/48 (6.25%)  3 3/48 (6.25%)  5 3/45 (6.67%)  7
Procedural hypotension  1  1/48 (2.08%)  1 5/48 (10.42%)  5 0/48 (0.00%)  0 3/45 (6.67%)  3
Procedural pain  1  21/48 (43.75%)  26 16/48 (33.33%)  17 18/48 (37.50%)  21 16/45 (35.56%)  17
Nervous system disorders         
Dysgeusia  1  0/48 (0.00%)  0 0/48 (0.00%)  0 0/48 (0.00%)  0 3/45 (6.67%)  3
Headache  1  3/48 (6.25%)  3 2/48 (4.17%)  2 3/48 (6.25%)  3 5/45 (11.11%)  5
Psychiatric disorders         
Insomnia  1  0/48 (0.00%)  0 3/48 (6.25%)  3 1/48 (2.08%)  1 0/45 (0.00%)  0
Sleep disorder  1  2/48 (4.17%)  2 3/48 (6.25%)  3 1/48 (2.08%)  2 1/45 (2.22%)  1
Respiratory, thoracic and mediastinal disorders         
Pharyngolaryngeal pain  1  4/48 (8.33%)  4 4/48 (8.33%)  4 1/48 (2.08%)  1 2/45 (4.44%)  2
1
Term from vocabulary, MedDRA 9.0
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.
Any 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
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00451217     History of Changes
Other Study ID Numbers: P05960
19.4.301 ( Other Identifier: Organon Protocol Number )
MK-8616-033 ( Other Identifier: Merck Protocol Number )
First Submitted: March 22, 2007
First Posted: March 23, 2007
Results First Submitted: August 30, 2018
Results First Posted: February 18, 2019
Last Update Posted: March 4, 2019