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The Muscle Relaxation-study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anne Kathrine Staehr-Rye, Herlev Hospital
ClinicalTrials.gov Identifier:
NCT01523886
First received: January 19, 2012
Last updated: March 16, 2014
Last verified: March 2014
Results First Received: January 16, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Cholecystectomy, Laparoscopic
Intervention: Drug: Rocuronium

  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
No text entered.

Reporting Groups
  Description
Deep Neuromuscular Blockade Rocuronium: Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h
Moderate Neuromuscular Blockade Rocuronium: Intravenous use: 0,3 mg/kg followed by NaCl-infusion

Participant Flow:   Overall Study
    Deep Neuromuscular Blockade     Moderate Neuromuscular Blockade  
STARTED     25     24  
COMPLETED     25     23  
NOT COMPLETED     0     1  
surgery cancelled                 0                 1  



  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
Deep Neuromuscular Blockade Rocuronium: Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h
Moderate Neuromuscular Blockade Rocuronium: Intravenous use: 0,3 mg/kg followed by NaCl-infusion
Total Total of all reporting groups

Baseline Measures
    Deep Neuromuscular Blockade     Moderate Neuromuscular Blockade     Total  
Number of Participants  
[units: participants]
  25     23     48  
Age  
[units: years]
Median ( Inter-Quartile Range )
  45  
  ( 42 to 49 )  
  48  
  ( 35 to 59 )  
  45  
  ( 36 to 56 )  
Gender  
[units: participants]
     
Female     15     17     32  
Male     10     6     16  
Region of Enrollment  
[units: participants]
     
Denmark     25     23     48  



  Outcome Measures

1.  Primary:   The Percentage of Patients With Optimal Surgical Space Conditions ( 1 at a 4-step Scale) Assessed at the Time During Surgery, When View Was Less   [ Time Frame: From surgical incision to last suture has been placed, an expected average of 30 minutes ]

2.  Secondary:   Surgical Space Conditions   [ Time Frame: From surgical incision to last suture has been placed, an expected average of 30 minutes. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Surgical Space Conditions   [ Time Frame: From surgical incision to last suture has been placed, an expected average of 30 minutes. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Surgical Space Conditions   [ Time Frame: During dissection of the gallbladder ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Pain   [ Time Frame: Preoperatively to 7 days after surgery ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Pain   [ Time Frame: At arrival to the postanesthesia care department, 2 hours and 1 day after surgery ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Normal Functional Level   [ Time Frame: from the day of surgery to re-establishing normal functional level - an expected average of 7 days. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Surgical Procedures at Low Pneumoperitoneum   [ Time Frame: From surgical incision to last suture has been placed, an expected average of 30 minutes. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

9.  Secondary:   Duration of Surgery   [ Time Frame: From surgical incision to last suture has been placed. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

10.  Secondary:   Duration of Anesthesia   [ Time Frame: From induction of anesthesia to patient ready to leave the operating theatre ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

11.  Secondary:   Consumption of Analgesics   [ Time Frame: The first 24 hours after surgery ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

12.  Secondary:   Nausea and Vomiting   [ Time Frame: The first 24 hours after surgery ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

13.  Secondary:   Anti-emetics   [ Time Frame: During the first 24 hours after surgery ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Mona R Gätke, MD, PH.D.
Organization: Herlev Hospital
phone: 004538662420
e-mail: mona.gatke@regionh.dk


No publications provided


Responsible Party: Anne Kathrine Staehr-Rye, Herlev Hospital
ClinicalTrials.gov Identifier: NCT01523886     History of Changes
Other Study ID Numbers: 2011-441
Study First Received: January 19, 2012
Results First Received: January 16, 2014
Last Updated: March 16, 2014
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency