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Trial record 33 of 186 for:    GLYCOPYRROLATE

Study of Sugammadex Versus Usual Care on Incidence of Residual Blockade at Post Anesthesia Care Unit Admission (P07981)

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ClinicalTrials.gov Identifier: NCT01479764
Recruitment Status : Completed
First Posted : November 24, 2011
Results First Posted : December 31, 2013
Last Update Posted : June 6, 2017
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 Surgical Procedures, Elective
Interventions Drug: Sugammadex
Drug: Neostigmine
Drug: Glycopyrrolate
Enrollment 154
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sugammadex Neostigmine/Glycopyrrolate
Hide Arm/Group Description Participants receive a single intravenous (IV) bolus dose of sugammadex, 2 or 4 mg/kg, depending on level of neuromuscular recovery Participants receive a single IV bolus dose of neostigmine/glycopyrrolate (neostigmine total dose not to exceed 5 mg) per usual practice
Period Title: Randomized
Started 76 78
Completed 74 [1] 77 [2]
Not Completed 2 1
Reason Not Completed
Adverse Event             1             1
Withdrawal by Subject             1             0
[1]
2 randomized participants did not receive study drug
[2]
1 randomized participant did not receive study drug
Period Title: Treated
Started 74 77
Completed 74 75
Not Completed 0 2
Reason Not Completed
Lost to Follow-up             0             2
Arm/Group Title Sugammadex Neostigmine/Glycopyrrolate Total
Hide Arm/Group Description Participants receive a single intravenous (IV) bolus dose of sugammadex, 2 or 4 mg/kg, depending on level of neuromuscular recovery Participants receive a single IV bolus dose of neostigmine/glycopyrrolate (neostigmine total dose not to exceed 5 mg) per usual practice Total of all reporting groups
Overall Number of Baseline Participants 74 77 151
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 74 participants 77 participants 151 participants
56.4  (12.8) 57.0  (12.7) 56.7  (12.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants 77 participants 151 participants
Female
27
  36.5%
34
  44.2%
61
  40.4%
Male
47
  63.5%
43
  55.8%
90
  59.6%
1.Primary Outcome
Title Incidence of Residual Neuromuscular Blockade (NMB) as Defined by a Train-of-Four (TOF) Ratio <0.9 at Post Anesthesia Care Unit (PACU) Entry
Hide Description Neuromuscular functioning was monitored by applying four TOF electrical stimulations to the ulnar nerve and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) 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, with a higher ratio indicating greater recovery from NMB. A T4/T1 Ratio of <0.9 is indicative of residual NMB.
Time Frame At PACU entry on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate) and had a reliable TOF measurement at PACU entry.
Arm/Group Title Sugammadex Neostigmine/Glycopyrrolate
Hide Arm/Group Description:
Participants receive a single intravenous (IV) bolus dose of sugammadex, 2 or 4 mg/kg, depending on level of neuromuscular recovery
Participants receive a single IV bolus dose of neostigmine/glycopyrrolate (neostigmine total dose not to exceed 5 mg) per usual practice
Overall Number of Participants Analyzed 74 76
Measure Type: Number
Unit of Measure: participants
0 33
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sugammadex, Neostigmine/Glycopyrrolate
Comments Sugammadex is the numerator and Neostigmine/Glycopyrrolate is the denominator.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Pearson's Chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
0.000 to 0.059
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Time From Start of Study Drug Administration to Operating Room Discharge-ready
Hide Description The time of operating room discharge readiness was determined by the surgical team based on clinical evaluations.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate).
Arm/Group Title Sugammadex Neostigmine/Glycopyrrolate
Hide Arm/Group Description:
Participants receive a single intravenous (IV) bolus dose of sugammadex, 2 or 4 mg/kg, depending on level of neuromuscular recovery
Participants receive a single IV bolus dose of neostigmine/glycopyrrolate (neostigmine total dose not to exceed 5 mg) per usual practice
Overall Number of Participants Analyzed 74 77
Least Squares Mean (95% Confidence Interval)
Unit of Measure: minutes
15.02
(13.23 to 17.05)
18.05
(15.94 to 20.43)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sugammadex, Neostigmine/Glycopyrrolate
Comments Sugammadex is the numerator and neostigmine/glycopyrrolate is the denominator. Used log-transformed time intervals.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.021
Comments [Not Specified]
Method ANCOVA
Comments Adjusted for age, American Society of Anesthesiologists class, Body Mass Index, comorbidity index & length of surgical procedure
Method of Estimation Estimation Parameter Estimated Ratio of Geometric Means
Estimated Value 0.83
Confidence Interval (2-Sided) 95%
0.71 to 0.97
Estimation Comments [Not Specified]
Time Frame Up to 7 days after administration of study drug
Adverse Event Reporting Description Treatment emergent adverse events in the All Patients as Treated population which consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate).
 
Arm/Group Title Sugammadex Neostigmine/Glycopyrrolate
Hide Arm/Group Description Participants receive a single intravenous (IV) bolus dose of sugammadex, 2 or 4 mg/kg, depending on level of neuromuscular recovery Participants receive a single IV bolus dose of neostigmine/glycopyrrolate (neostigmine total dose not to exceed 5 mg) per usual practice
All-Cause Mortality
Sugammadex Neostigmine/Glycopyrrolate
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Sugammadex Neostigmine/Glycopyrrolate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/74 (9.46%)      8/77 (10.39%)    
Cardiac disorders     
Acute myocardial infarction  1  0/74 (0.00%)  0 1/77 (1.30%)  1
Gastrointestinal disorders     
Diarrhoea  1  1/74 (1.35%)  1 1/77 (1.30%)  1
Gastronintestinal haemorrhage  1  0/74 (0.00%)  0 1/77 (1.30%)  1
Ileus  1  3/74 (4.05%)  3 3/77 (3.90%)  3
Ileus paralytic  1  1/74 (1.35%)  1 0/77 (0.00%)  0
Nausea  1  0/74 (0.00%)  0 1/77 (1.30%)  1
Vomiting  1  0/74 (0.00%)  0 1/77 (1.30%)  1
General disorders     
Pyrexia  1  1/74 (1.35%)  1 0/77 (0.00%)  0
Infections and infestations     
Pneumonia  1  0/74 (0.00%)  0 1/77 (1.30%)  1
Wound infection  1  0/74 (0.00%)  0 1/77 (1.30%)  1
Injury, poisoning and procedural complications     
Delayed recovery from anaesthesia  1  0/74 (0.00%)  0 1/77 (1.30%)  1
Post procedural haemorrhage  1  1/74 (1.35%)  1 0/77 (0.00%)  0
Post procedural myocardial infarction  1  1/74 (1.35%)  1 0/77 (0.00%)  0
Procedural haemorrhage  1  0/74 (0.00%)  0 1/77 (1.30%)  1
Musculoskeletal and connective tissue disorders     
Back pain  1  1/74 (1.35%)  1 0/77 (0.00%)  0
Psychiatric disorders     
Delirium  1  1/74 (1.35%)  1 0/77 (0.00%)  0
Renal and urinary disorders     
Urinary retention  1  0/74 (0.00%)  0 1/77 (1.30%)  1
Vascular disorders     
Haemorrhage  1  1/74 (1.35%)  1 0/77 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sugammadex Neostigmine/Glycopyrrolate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/74 (24.32%)      18/77 (23.38%)    
Cardiac disorders     
Bradycardia  1  0/74 (0.00%)  0 4/77 (5.19%)  4
Tachycardia  1  1/74 (1.35%)  1 4/77 (5.19%)  5
Gastrointestinal disorders     
Nausea  1  1/74 (1.35%)  1 4/77 (5.19%)  4
Vomiting  1  1/74 (1.35%)  1 4/77 (5.19%)  4
General disorders     
Pyrexia  1  6/74 (8.11%)  6 6/77 (7.79%)  7
Vascular disorders     
Hypertension  1  10/74 (13.51%)  10 2/77 (2.60%)  2
Hypotension  1  4/74 (5.41%)  4 6/77 (7.79%)  6
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
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 investigator agrees to provide to the Sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication and slides and texts of oral or other presentations that report any results of the trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp.
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01479764     History of Changes
Other Study ID Numbers: P07981
MK-8616-064 ( Other Identifier: Merck study number )
First Submitted: November 22, 2011
First Posted: November 24, 2011
Results First Submitted: August 26, 2013
Results First Posted: December 31, 2013
Last Update Posted: June 6, 2017