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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00758485
First received: September 23, 2008
Last updated: March 18, 2014
Last verified: March 2014
Results First Received: March 11, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Anesthesia
Neuromuscular Blockade
Interventions: Drug: Sugammadex
Drug: 0.9% sodium chloride (NaCl)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from 10 sites in Germany from November 2008 to May 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Sugammadex 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
Placebo Participants receiving Placebo (0.9% sodium chloride[NaCl]) at a target depth of NMB of 1-2 PTC after the last dose of rocuronium

Participant Flow:   Overall Study
    Sugammadex     Placebo  
STARTED     70     70  
TREATED     69     68  
COMPLETED     69     67  
NOT COMPLETED     1     3  
Lost to Follow-up                 0                 1  
Not Treated                 1                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Sugammadex Participants receiving 4.0 mg.kg-1 Sugammadex at a target depth of NMB of 1-2 PTC after the last dose of rocuronium.
Placebo Participants receiving Placebo (0.9% NaCl) at a target depth of NMB of 1-2 PTC after the last dose of rocuronium.
Total Total of all reporting groups

Baseline Measures
    Sugammadex     Placebo     Total  
Number of Participants  
[units: participants]
  69     68     137  
Age  
[units: years]
Mean ± Standard Deviation
  57  ± 17     57  ± 14     57  ± 16  
Gender  
[units: participants]
     
Female     21     25     46  
Male     48     43     91  



  Outcome Measures
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1.  Primary:   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   [ 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) ]

2.  Secondary:   Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.7   [ 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) ]

3.  Secondary:   Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.8   [ 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) ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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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.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00758485     History of Changes
Other Study ID Numbers: P05767, 2008-002518-23, 19.4.316, MK-8616-004
Study First Received: September 23, 2008
Results First Received: March 11, 2013
Last Updated: March 18, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices