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Trial record 84 of 58417 for:    Placebo

Comparing 4.0 mg.Kg-1 Sugammadex With Placebo in the Reversal of Profound Neuromuscular Blockade (P05767)

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ClinicalTrials.gov Identifier: NCT00758485
Recruitment Status : Completed
First Posted : September 25, 2008
Results First Posted : April 22, 2013
Last Update Posted : August 21, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Anesthesia
Neuromuscular Blockade
Interventions Drug: Sugammadex
Drug: 0.9% sodium chloride (NaCl)
Enrollment 140
Recruitment Details Participants were recruited from 10 sites in Germany from November 2008 to May 2009.
Pre-assignment Details  
Arm/Group Title Sugammadex Placebo
Hide Arm/Group Description Participants receiving 4.0 mg.kg-1 Sugammadex at a target depth of neuromuscular blockade (NMB) of 1-2 Post Tetanic Count (PTC) after the last dose of rocuronium Participants receiving Placebo (0.9% sodium chloride[NaCl]) at a target depth of NMB of 1-2 PTC after the last dose of rocuronium
Period Title: Overall Study
Started 70 70
TREATED 69 68
Completed 69 67
Not Completed 1 3
Reason Not Completed
Lost to Follow-up             0             1
Not Treated             1             2
Arm/Group Title Sugammadex Placebo Total
Hide Arm/Group Description Participants receiving 4.0 mg.kg-1 Sugammadex at a target depth of NMB of 1-2 PTC after the last dose of rocuronium. Participants receiving Placebo (0.9% NaCl) at a target depth of NMB of 1-2 PTC after the last dose of rocuronium. Total of all reporting groups
Overall Number of Baseline Participants 69 68 137
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 69 participants 68 participants 137 participants
57  (17) 57  (14) 57  (16)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 69 participants 68 participants 137 participants
Female
21
  30.4%
25
  36.8%
46
  33.6%
Male
48
  69.6%
43
  63.2%
91
  66.4%
1.Primary Outcome
Title Time From Start of Administration of Investigational Medicinal Product (IMP, Sugammadex or Placebo) 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 & 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 (a percentage that is expressed as a decimal of up to 1.0) indicates the extent of recovery from neuromuscular blockade (NMB), with a higher ratio indicating a greater recovery from NMB. In this study, twitch responses were recorded until the T4/T1 Ratio reached >=0.9, the minimum acceptable ratio that indicated complete recovery from NMB. A shorter time to recovery of the T4/T1 Ratio >=0.9 indicates a faster recovery from NMB.
Time Frame From Start of IMP Administration to Recovery of the T4/T1 Ratio to 0.9 (estimated from ~2 minutes up to ~90 minutes)
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat (ITT) Population consisted of all participants who received either Sugammadex or Placebo and had at least one efficacy measurement. Imputed recovery times were used in cases of missing times.
Arm/Group Title Sugammadex Placebo
Hide Arm/Group Description:
Participants receiving 4.0 mg/kg-1 Sugammadex at a target depth of NMB of 1-2 Post Tetanic Count (PTC) after the last dose of rocuronium
Participants receiving Placebo (0.9% NaCl) at a target depth of NMB of 1-2 PTC after the last dose of rocuronium
Overall Number of Participants Analyzed 69 65
Geometric Mean (95% Confidence Interval)
Unit of Measure: minutes
2.2
(1.9 to 2.5)
89.8
(80.1 to 100.7)
2.Secondary Outcome
Title Time From Start of Administration of IMP 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 & 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 (a percentage that is expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating a greater recovery from NMB.
Time Frame From Start of IMP Administration to Recovery of the T4/T1 Ratio to 0.7 (estimated from ~1 minute up to ~70 minutes)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT Population consisted of all participants who received either Sugammadex or Placebo and had at least one efficacy measurement. Imputed recovery times were used in cases of missing times.
Arm/Group Title Sugammadex Placebo
Hide Arm/Group Description:
Participants receiving 4.0 mg.kg-1 Sugammadex at a target depth of NMB of 1-2 PTC after the last dose of rocuronium
Participants receiving Placebo (0.9% NaCl) at a target depth of NMB of 1-2 PTC after the last dose of rocuronium
Overall Number of Participants Analyzed 69 65
Geometric Mean (95% Confidence Interval)
Unit of Measure: minutes
1.6
(1.4 to 1.8)
70.1
(62.7 to 78.4)
3.Secondary Outcome
Title Time From Start of Administration of IMP 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 & 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 (a percentage that is expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating a greater recovery from NMB.
Time Frame From Start of IMP Administration to Recovery of the T4/T1 Ratio to 0.8 (estimated from ~2 minutes up to ~80 minutes)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT Population consisted of all participants who received either Sugammadex or Placebo and had at least one efficacy measurement. Imputed recovery times were used in cases of missing times.
Arm/Group Title Sugammadex Placebo
Hide Arm/Group Description:
Participants receiving 4.0 mg.kg-1 Sugammadex at a target depth of NMB of 1-2 PTC after the last dose of rocuronium
Participants receiving Placebo (0.9% NaCl) at a target depth of NMB of 1-2 PTC after the last dose of rocuronium
Overall Number of Participants Analyzed 69 65
Geometric Mean (95% Confidence Interval)
Unit of Measure: minutes
1.8
(1.6 to 2.0)
78.8
(70.2 to 88.5)
Time Frame Up to 7 days after administration of IMP
Adverse Event Reporting Description The All Subjects Treated Population consisted of all randomized participants who received IMP.
 
Arm/Group Title Sugammadex Placebo
Hide Arm/Group Description Participants receiving 4.0 mg.kg-1 Sugammadex at a target depth of NMB of 1-2 PTC after the last dose of rocuronium Participants receiving Placebo (0.9% NaCl) at a target depth of NMB of 1-2 PTC after the last dose of rocuronium
All-Cause Mortality
Sugammadex Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Sugammadex Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/69 (5.80%)      4/68 (5.88%)    
Gastrointestinal disorders     
Diverticular Perforation  0/69 (0.00%)  0 1/68 (1.47%)  1
Injury, poisoning and procedural complications     
Post Procedural Complication  1/69 (1.45%)  1 1/68 (1.47%)  1
Post Procedural Haemorrhage  1/69 (1.45%)  1 1/68 (1.47%)  1
Skin Laceration  0/69 (0.00%)  0 1/68 (1.47%)  1
Psychiatric disorders     
Alcohol Withdrawal Syndrome  1/69 (1.45%)  1 0/68 (0.00%)  0
Vascular disorders     
Lymphocele  1/69 (1.45%)  1 0/68 (0.00%)  0
1
Term from vocabulary, MedDRA (12.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sugammadex Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   44/69 (63.77%)      48/68 (70.59%)    
Gastrointestinal disorders     
Constipation  6/69 (8.70%)  6 4/68 (5.88%)  4
Flatulence  4/69 (5.80%)  4 7/68 (10.29%)  7
Nausea  9/69 (13.04%)  9 11/68 (16.18%)  12
Vomiting  5/69 (7.25%)  5 5/68 (7.35%)  5
General disorders     
Pyrexia  4/69 (5.80%)  4 4/68 (5.88%)  4
Injury, poisoning and procedural complications     
Procedural Nausea  3/69 (4.35%)  3 4/68 (5.88%)  4
Procedural Pain  29/69 (42.03%)  30 32/68 (47.06%)  33
Wound Complication  11/69 (15.94%)  13 10/68 (14.71%)  10
Nervous system disorders     
Dizziness  1/69 (1.45%)  1 5/68 (7.35%)  5
Headache  7/69 (10.14%)  7 5/68 (7.35%)  5
Psychiatric disorders     
Sleep Disorder  4/69 (5.80%)  4 4/68 (5.88%)  4
1
Term from vocabulary, MedDRA (12.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00758485     History of Changes
Other Study ID Numbers: P05767
2008-002518-23 ( EudraCT Number )
19.4.316 ( Other Identifier: Organon Protocol ID )
MK-8616-004 ( Other Identifier: Merck Protocol ID )
First Submitted: September 23, 2008
First Posted: September 25, 2008
Results First Submitted: March 11, 2013
Results First Posted: April 22, 2013
Last Update Posted: August 21, 2015