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A Study Comparing the Use of Deep or Standard Neuromuscular Blockade in Combination With Low or Standard Insufflation Pressures in Participants Undergoing Laparoscopic Cholecystectomy (P07982)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01728584
First Posted: November 20, 2012
Last Update Posted: June 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
Results First Submitted: March 12, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Gallbladder Disease
Interventions: Drug: Rocuronium
Other: Insufflation
Drug: Sugammadex

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were randomized to 4 arms based on combinations of neuromuscular blockade (NMB) depth and insufflation pressure level. During procedure, blinded surgeon could request that unblinded anesthetist change the randomized treatment conditions (“rescue intervention”), if surgeon considered surgical conditions to be unacceptable.

Reporting Groups
  Description
Standard NMB and Standard Insufflation Pressure Treatment condition for this reporting group is Standard (Std) NMB (depth of blockade at a targeted Train of Four [TOF] ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).
Standard NMB and Low Insufflation Pressure Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).
Deep NMB and Standard Insufflation Pressure Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 Post Tetanic Counts [PTCs])/Standard insufflation pressure (starting pressure of 12 mmHg).
Deep NMB and Low Insufflation Pressure Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).

Participant Flow:   Overall Study
    Standard NMB and Standard Insufflation Pressure   Standard NMB and Low Insufflation Pressure   Deep NMB and Standard Insufflation Pressure   Deep NMB and Low Insufflation Pressure
STARTED   36 [1]   30 [2]   31 [1]   30 [3] 
COMPLETED   28   30   30   29 
NOT COMPLETED   8   0   1   1 
Adverse Event                1                0                0                0 
Physician Decision                4                0                1                0 
Withdrawal by Subject                1                0                0                0 
Screen failure                1                0                0                0 
Other reason (not specified)                1                0                0                1 
[1] Randomized
[2] Randomized - NMB/pressure conditions were changed in 7 (2 to Std/Std, 4 to Deep/Std, 1 to Deep/Low)
[3] Randomized - NMB/pressure conditions were changed in 5 (all to Deep/Std)



  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.
All participants as randomized

Reporting Groups
  Description
Standard NMB and Standard Insufflation Pressure Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).
Standard NMB and Low Insufflation Pressure Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).
Deep NMB and Standard Insufflation Pressure Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Standard insufflation pressure (starting pressure of 12 mmHg).
Deep NMB and Low Insufflation Pressure Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).
Total Total of all reporting groups

Baseline Measures
   Standard NMB and Standard Insufflation Pressure   Standard NMB and Low Insufflation Pressure   Deep NMB and Standard Insufflation Pressure   Deep NMB and Low Insufflation Pressure   Total 
Overall Participants Analyzed 
[Units: Participants]
 36   30   31   30   127 
Age 
[Units: Years]
Mean (Standard Deviation)
 46.1  (17.7)   39.1  (13.6)   43.5  (15.6)   46.7  (13.8)   43.9  (15.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      15  41.7%      11  36.7%      13  41.9%      9  30.0%      48  37.8% 
Male      21  58.3%      19  63.3%      18  58.1%      21  70.0%      79  62.2% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Score on Surgeon's Assessment of Overall Satisfaction With the Surgical Conditions: By Depth of NMB (Standard, Deep) and Insufflation Pressure (Standard, Low)   [ Time Frame: End of surgery (Day 1) ]

2.  Primary:   Score on Surgeon's Assessment of Overall Satisfaction With the Surgical Conditions: By Treatment Arm   [ Time Frame: End of surgery (Day 1) ]

3.  Secondary:   Participant's Overall Average Pain Score in the First 24 Hours After Administration of Sugammadex: By Depth of NMB (Standard, Deep) and Insufflation Pressure (Standard, Low)   [ Time Frame: Up to 24 hours after administration of sugammadex on Day 1 ]

4.  Secondary:   Participant's Overall Average Pain Score in the First 24 Hours After Administration of Sugammadex: By Treatment Arm   [ Time Frame: Up to 24 hours after administration of sugammadex on Day 1 ]

5.  Secondary:   Score on Surgeon's Assessment of Overall Satisfaction With the Visibility of the Surgical Field: By Depth of NMB (Standard, Deep)   [ Time Frame: End of surgery (Day 1) ]

6.  Secondary:   Score on Surgeon's Assessment of the Overall Adequacy of Muscle Relaxation During Surgery: By Depth of NMB (Standard, Deep)   [ Time Frame: End of surgery (Day 1) ]

7.  Secondary:   Score on Surgeon's Assessment of the Overall Adequacy of Insufflation Pressure During Surgery: By Depth of NMB (Standard, Deep)   [ Time Frame: End of surgery (Day 1) ]

8.  Secondary:   Number of Times Participant's Movements or Increased Muscle Tone Interfered With the Surgical Conditions During Laparoscopy: By Depth of NMB (Standard, Deep)   [ Time Frame: During surgery, approximate duration of 1-2 hours (Day 1) ]

9.  Secondary:   Score on Surgeon's Assessment of the Effect Participant's Movements During Surgery Had on the Overall Surgical Procedure: By Depth of NMB (Standard, Deep)   [ Time Frame: End of surgery (Day 1) ]

10.  Secondary:   Number of Participants With Rescue Actions Performed During Surgery in Order to Improve Insufficient Surgical Conditions: By Treatment Arm   [ Time Frame: During surgery, approximate duration of 1-2 hours (Day 1) ]

11.  Secondary:   Participant's Daily Assessment of Overall Pain at Rest During Post Operative Period: By Treatment Arm   [ Time Frame: Days 2 to 8 ]

12.  Secondary:   Participant's Daily Assessment of Provoked Pain During Post Operative Period: By Treatment Arm   [ Time Frame: Days 2 to 8 ]

13.  Secondary:   Participant's Daily Assessment of Shoulder Pain During Post Operative Period: By Treatment Arm   [ Time Frame: Days 2 to 8 ]

14.  Secondary:   Number of Participants Using Pain/Analgesic Medication During Post Operative Period: By Treatment Arm   [ Time Frame: Up to Day 8 ]


  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 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: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


Publications of Results:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01728584     History of Changes
Other Study ID Numbers: P07982
MK-8616-076 ( Other Identifier: Merck )
2012-001886-33 ( EudraCT Number )
First Submitted: October 16, 2012
First Posted: November 20, 2012
Results First Submitted: March 12, 2015
Results First Posted: March 23, 2015
Last Update Posted: June 6, 2017