Comparison of Sugammadex With Neostigmine During Laparoscopic Cholecystectomy or Appendectomy (P05699)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00724932
First received: July 28, 2008
Last updated: October 9, 2014
Last verified: October 2014
Results First Received: March 14, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Anesthesia, General
Interventions: Drug: Rocuronium
Drug: Sugammadex
Drug: Neostigmine
Drug: Atropine

  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, Russia, Finland and the United Kingdom between July 2008 and March 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 1-2 Post Tetanic Count (PTC)
Neostigmine Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine: atropine) at reappearance of the second twitch (T2)

Participant Flow:   Overall Study
    Sugammadex     Neostigmine  
STARTED     70     70  
COMPLETED     65     67  
NOT COMPLETED     5     3  
Lost to Follow-up                 1                 0  
Not treated                 4                 3  



  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.
The Baseline Analysis Population consisted of randomized participants who received investigational medicinal product (IMP). Four participants randomized to Sugammadex did not receive IMP and three participants randomized to receive Neostigmine did not receive IMP.

Reporting Groups
  Description
Sugammadex Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
Neostigmine Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
Total Total of all reporting groups

Baseline Measures
    Sugammadex     Neostigmine     Total  
Number of Participants  
[units: participants]
  66     67     133  
Age  
[units: years]
Mean ± Standard Deviation
  51  ± 16     51  ± 14     51  ± 15  
Gender  
[units: participants]
     
Female     49     43     92  
Male     17     24     41  



  Outcome Measures
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1.  Primary:   Time From Start of Administration of Investigational Medicinal Product (IMP, Sugammadex or Neostigmine) to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9   [ Time Frame: From start of IMP administration to recovery of T4/T1 ratio to 0.9 (ranging from ~2 minutes to ~9 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 T4/T1 Ratio to 0.7 (ranging from ~2 minutes to ~5 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 T4/T1 Ratio to 0.8 (ranging from ~2 minutes to ~6 minutes) ]

4.  Secondary:   Number of Participants Who Experienced Pre-treatment Serious Adverse Events (SAEs) and Post-treatment SAEs   [ Time Frame: From signing of informed consent to end of trial (7 days after surgery) ]

5.  Secondary:   Number of Participants Who Experienced Pre-treatment Non-serious Adverse Events (AEs) and Post-treatment Non-serious AEs   [ Time Frame: From signing of informed consent to end of trial (7 days after surgery) ]

6.  Other Pre-specified:   Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.5 and 0.6   [ Time Frame: From start of IMP administration to recovery of T4/T1 Ratio to 0.5 and 0.6 (ranging from ~1 minute to ~4 minutes) ]

7.  Other Pre-specified:   Time From Start of Administration of the Last Dose of Rocuronium to Recovery of the T4/T1 Ratio to 0.5, 0.6, 0.7, 0.8 and 0.9   [ Time Frame: From start of last dose of rocuronium to recovery of T4/T1 Ratio to 0.5, 0.6, 0.7, 0.8 and 0.9 (ranging from ~12 minutes to ~36 minutes) ]

8.  Other Pre-specified:   Time From Start of Administration of the Last Dose of Rocuronium to the Time of 1-2 PTC in the 4.0 mg.Kg-1 Sugammadex Group   [ Time Frame: From last dose of rocuronium to 1-2 PTC (up to ~9 minutes) ]

9.  Other Pre-specified:   Time From Start of Administration of the Last Dose of Rocuronium to the Time of Reappearance of T2 in the 50 μg.Kg-1 Neostigmine Group   [ Time Frame: From last dose of rocuronium to reappearance of T2 (up to ~26 minutes) ]

10.  Other Pre-specified:   Mean Systolic Blood Pressure   [ Time Frame: At screening, pre-rocuronium, pre-IMP, at 2, 5, 10, and 30 minutes post-IMP, and at the post-anesthetic visit (the day after surgery) ]

11.  Other Pre-specified:   Mean Diastolic Blood Pressure   [ Time Frame: At screening, pre-rocuronium, pre-IMP, at 2, 5, 10, and 30 minutes post-IMP, and at the post-anesthetic visit (the day after surgery) ]

12.  Other Pre-specified:   Mean Heart Rate   [ Time Frame: At screening, pre-rocuronium, pre-IMP, at 2, 5, 10, and 30 minutes post-IMP, and at the post-anesthetic visit (the day after surgery) ]

13.  Other Pre-specified:   Number of Participants Who Had Physical Examinations   [ Time Frame: At screening (within 7 days prior to surgery) and at the post-anesthetic visit (the day after surgery) ]

14.  Other Pre-specified:   Number of Participants With Train-of-Four- (TOF-) Watch® SX and Arm Board Related Adverse Events   [ Time Frame: From induction of anesthesia to recovery from NMB (up to ~3 hours) ]

15.  Other Pre-specified:   Number of Participants With Reoccurrence of Neuromuscular Blockade Based on the Train-of-Four- (TOF-) Watch® SX Recording (i.e. a Decline in T4/T1 Ratio From >=0.9 to <0.8 in at Least Three Consecutive TOF Values)   [ Time Frame: Up to 30 minutes after IMP administration ]

16.  Other Pre-specified:   Number of Participants With Clinical Evidence of Reoccurrence of Neuromuscular Blockade or Residual Neuromuscular Blockade (Routine Oxygen Saturation by Pulse Oximetry and Breath Frequency Measurement)   [ Time Frame: Up to 24 hours after IMP administration ]

17.  Other Pre-specified:   Number of Participants With Events Due to a Possible Interaction of Sugammadex With Endogenous Compounds or With Exogenous Compounds Other Than Rocuronium   [ Time Frame: Up to 7 days after IMP administration ]

18.  Other Pre-specified:   Monitoring of Clinical Signs of Recovery According to Routine Anesthetic Procedures at the Trial Sites   [ Time Frame: Up to PACU discharge (up to ~4.5 hours) ]

19.  Other Pre-specified:   Number of Female Participants or Partners of Male Participants Who Became Pregnant During Study   [ Time Frame: Up to 30 days after IMP administration ]

20.  Other Pre-specified:   Time From Operating Room Admission to Operating Room Discharge Ready   [ Time Frame: From Operating Room admission to Operating Room discharge ready (up to ~3 hours) ]

21.  Other Pre-specified:   Time From Operating Room Admission to Actual Operating Room Discharge   [ Time Frame: From Operating Room admission to actual Operating Room discharge (up to ~3 hours) ]

22.  Other Pre-specified:   Time From Operating Room Discharge Ready to Actual Operating Room Discharge   [ Time Frame: From Operating Room discharge ready to actual Operating Room discharge (up to ~5 minutes) ]

23.  Other Pre-specified:   Time From Start of IMP Administration to T4/T1 Ratio of <=0.60, >0.60 - <=0.70, >0.70 - <=0.80, >0.80 - <0.90 and >=0.90   [ Time Frame: From start of IMP administration to recovery of the T4/T1 ratio to the designated value (ranging from ~1 minute to ~10 minutes) ]

24.  Other Pre-specified:   Time From Start of IMP Administration to Tracheal Extubation   [ Time Frame: From start of IMP administration to tracheal extubation (up to ~21 minutes) ]

25.  Other Pre-specified:   Time From Start of IMP Administration to Operating Room Discharge Ready   [ Time Frame: From start of IMP administration to Operating Room discharge ready (up to ~21 minutes) ]

26.  Other Pre-specified:   Time From Start of IMP Administration to Actual Operating Room Discharge   [ Time Frame: From start of IMP administration to actual Operating Room discharge (up to ~26 minutes) ]

27.  Other Pre-specified:   Time From Tracheal Extubation to Operating Room Discharge Ready   [ Time Frame: From tracheal extubation to Operating Room discharge ready (up to ~1 minute) ]

28.  Other Pre-specified:   Time From Tracheal Extubation to Actual Operating Room Discharge   [ Time Frame: From tracheal extubation to actual OR discharge (up to ~5 minutes) ]

29.  Other Pre-specified:   Time From Operating Room Discharge Ready to Post Anesthetic Care Unit (PACU) Discharge Ready   [ Time Frame: From Operating Room discharge ready to PACU discharge ready (up to ~33 minutes) ]

30.  Other Pre-specified:   Time From Operating Room Discharge Ready to Actual PACU Discharge   [ Time Frame: From Operating Room discharge ready to actual PACU discharge (up to ~4.5 hours) ]

31.  Other Pre-specified:   Time From Actual Operating Room Discharge to PACU Discharge Ready   [ Time Frame: From actual Operating Room discharge to PACU discharge ready (up to ~30 minutes) ]

32.  Other Pre-specified:   Time From Actual Operating Room Discharge to Actual PACU Discharge   [ Time Frame: From actual Operating Room discharge to actual PACU discharge (up to ~4.4 hours) ]

33.  Other Pre-specified:   Time From PACU Admit to PACU Discharge Ready   [ Time Frame: From PACU admit to PACU discharge ready (up to ~25 minutes) ]

34.  Other Pre-specified:   Time From PACU Admit to Actual PACU Discharge   [ Time Frame: From PACU admit to actual PACU discharge (up to ~4.3 hours) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
e-mail: ClinicalTrialsDisclosure@merck.com


Publications of Results:
Other Publications:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00724932     History of Changes
Other Study ID Numbers: P05699, 19.4.318, MK-8616-002, 2007-007951-14
Study First Received: July 28, 2008
Results First Received: March 14, 2013
Last Updated: October 9, 2014
Health Authority: Finland: Finnish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Russia: Ministry of Health of the Russian Federation
United Kingdom: Medicines and Healthcare Products Regulatory Agency