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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01479764
First received: November 22, 2011
Last updated: May 12, 2014
Last verified: May 2014
Results First Received: August 26, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Surgical Procedures, Elective
Interventions: Drug: Sugammadex
Drug: Neostigmine
Drug: Glycopyrrolate

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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 receive a single intravenous (IV) bolus dose of sugammadex, 2 or 4 mg/kg-1, depending on level of neuromuscular recovery
Neostigmine/Glycopyrrolate Participants receive a single IV bolus dose of neostigmine/glycopyrrolate (neostigmine total dose not to exceed 5 mg) per usual practice

Participant Flow for 2 periods

Period 1:   Randomized
    Sugammadex     Neostigmine/Glycopyrrolate  
STARTED     76     78  
COMPLETED     74 [1]   77 [2]
NOT COMPLETED     2     1  
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 2:   Treated
    Sugammadex     Neostigmine/Glycopyrrolate  
STARTED     74     77  
COMPLETED     74     75  
NOT COMPLETED     0     2  
Lost to Follow-up                 0                 2  



  Baseline Characteristics
  Hide Baseline Characteristics

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 receive a single intravenous (IV) bolus dose of sugammadex, 2 or 4 mg/kg-1, depending on level of neuromuscular recovery
Neostigmine/Glycopyrrolate Participants receive a single IV bolus dose of neostigmine/glycopyrrolate (neostigmine total dose not to exceed 5 mg) per usual practice
Total Total of all reporting groups

Baseline Measures
    Sugammadex     Neostigmine/Glycopyrrolate     Total  
Number of Participants  
[units: participants]
  74     77     151  
Age  
[units: years]
Mean ± Standard Deviation
  56.4  ± 12.8     57.0  ± 12.7     56.7  ± 12.7  
Gender  
[units: participants]
     
Female     27     34     61  
Male     47     43     90  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Incidence of Residual Neuromuscular Blockade (NMB) as Defined by a Train-of-Four (TOF) Ratio <0.9 at Post Anesthesia Care Unit (PACU) Entry   [ Time Frame: At PACU entry on Day 1 ]

2.  Secondary:   Time From Start of Study Drug Administration to Operating Room Discharge-ready   [ Time Frame: Day 1 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  More Information
  Hide More Information

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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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: NCT01479764     History of Changes
Other Study ID Numbers: P07981, MK-8616-064
Study First Received: November 22, 2011
Results First Received: August 26, 2013
Last Updated: May 12, 2014
Health Authority: United States: Food and Drug Administration