Incidence of Incomplete Postoperative Neuromuscular Recovery From Anesthesia (P07535)(Completed) (INSPIRE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01181349
First received: July 23, 2010
Last updated: October 25, 2013
Last verified: October 2013
Results First Received: February 29, 2012  
Study Type: Observational
Study Design: Observational Model: Cohort
Condition: Neuromuscular Blockade
Intervention: Other: Neuromuscular Blocking Agent (NMBA)

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
All Participants

Adult study participants undergoing different types of elective surgical procedures requiring general anesthesia

with neuromuscular blocking agents


Participant Flow:   Overall Study
    All Participants  
STARTED     350  
COMPLETED     350  
NOT COMPLETED     0  



  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.
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Reporting Groups
  Description
All Participants

Adult study participants undergoing different types of elective surgical procedures requiring general anesthesia

with neuromuscular blocking agents


Baseline Measures
    All Participants  
Number of Participants  
[units: participants]
  350  
Age  
[units: years]
Mean ± Standard Deviation
  54.3  ± 15.9  
Gender  
[units: participants]
 
Female     216  
Male     134  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Train-of-four (TOF) Ratio <0.9 at PACU Arrival   [ Time Frame: Upon arrival in the PACU ]

2.  Secondary:   Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Identified Neuromuscular Blocking Agents   [ Time Frame: From start of surgery through PACU arrival ]

3.  Secondary:   Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Propofol or Sevoflurane   [ Time Frame: From start of surgery through PACU arrival ]

4.  Secondary:   Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Neuromuscular Blockade Reversal Agents   [ Time Frame: From end of surgery through PACU arrival, an expected average of 10 minutes ]

5.  Secondary:   Number of Participants With and Without Postoperative Residual Neuromuscular Blockade With Postoperative Events   [ Time Frame: From end of surgery through hospital discharge, an expected average of 6 days ]


  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 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.


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
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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 by Merck Sharp & Dohme Corp.

Publications automatically indexed to this study:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01181349     History of Changes
Other Study ID Numbers: P07535
Study First Received: July 23, 2010
Results First Received: February 29, 2012
Last Updated: October 25, 2013
Health Authority: European Union: European Medicines Agency