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The Muscle Relaxation-study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01523886
First Posted: February 1, 2012
Last Update Posted: April 21, 2014
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):
Anne Kathrine Staehr-Rye, Herlev Hospital
January 19, 2012
February 1, 2012
January 16, 2014
April 21, 2014
April 21, 2014
March 2012
November 2012   (Final data collection date for primary outcome measure)
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 ]
The surgical space conditions (4-stage scale) assessed at the time during surgery, when view was less. The laparoscopies were performed by experienced surgeons, whom were asked to evaluate surgical space conditions with a 4-point scale : Grade 1 ("optimal") = "optimal" surgical space conditions; Grade 2 (good) = non-optimal conditions, but an intervention was not considered; Grade 3 (acceptable) = an intervention was considered in order to improve surgical space; Grade 4 (poor) = inadequate conditions and an intervention was necessary in order to ensure acceptable surgical space.
Surgical space conditions [ Time Frame: From surgical incision to last suture has been placed, an expected average of 30 minutes ]
The surgical space conditions (4-stage scale) assessed at the time during surgery, when they were poorest.
Complete list of historical versions of study NCT01523886 on ClinicalTrials.gov Archive Site
  • Surgical Space Conditions [ Time Frame: From surgical incision to last suture has been placed, an expected average of 30 minutes. ]
    The surgical space conditions (VAS 0-100) assessed at the time during surgery, when they were poorest
  • Surgical Space Conditions [ Time Frame: From surgical incision to last suture has been placed, an expected average of 30 minutes. ]
    The average surgical space conditions (VAS 0-100 and 4-stage scale) during the procedure.
  • Surgical Space Conditions [ Time Frame: During dissection of the gallbladder ]
    The surgical space conditions during dissection of the gallbladder (4-stage scale and VAS 0-100).
  • Pain [ Time Frame: Preoperatively to 7 days after surgery ]
    Pain (shoulder, incision, deep abdominal and general) as the area under the curve from preoperatively to 7 days after surgery.
  • Pain [ Time Frame: At arrival to the postanesthesia care department, 2 hours and 1 day after surgery ]
    Pain (shoulder, incision, deeop abdominal and general) at arrival to the postanesthesia care department, 2 hours and 1 day after surgery.
  • Normal Functional Level [ Time Frame: from the day of surgery to re-establishing normal functional level - an expected average of 7 days. ]
    Numer of days before re-establing normal functional level
  • Surgical Procedures at Low Pneumoperitoneum [ Time Frame: From surgical incision to last suture has been placed, an expected average of 30 minutes. ]
    Number of procedures which can be done with pneumoperitoneum 8 mmHg
  • Duration of Surgery [ Time Frame: From surgical incision to last suture has been placed. ]
    Duration of surgery
  • Duration of Anesthesia [ Time Frame: From induction of anesthesia to patient ready to leave the operating theatre ]
    Duration of anesthesia
  • Consumption of Analgesics [ Time Frame: The first 24 hours after surgery ]
    Consumption of analgesics during the first 24 hours after surgery
  • Nausea and Vomiting [ Time Frame: The first 24 hours after surgery ]
    The incidence of nausea and vomiting during the first 24 hours after surgery
  • Anti-emetics [ Time Frame: During the first 24 hours after surgery ]
    Use of anti-emetics during the first 24 hours after surgery
Same as current
Not Provided
Not Provided
 
The Muscle Relaxation-study
Optimization of Surgical Conditions During Laparoscopic Cholecystectomy With Deep or Moderate Neuromuscular Blockade

The purpose of this investigation is to compare the surgical conditions during laparoscopic cholecystectomy at a low intra-abdominal pressure with deep or moderate muscle relaxation.

The primary hypothesis is that surgical conditions during laparoscopic cholecystectomy are better with deep muscle relaxation than moderate muscle relaxation.

The purpose of this investigation is to compare the surgical conditions with two degrees of neuromuscular blockade in patients who have laparoscopic cholecystectomy done with pneumoperitoneum 8 mmHg.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Cholecystectomy, Laparoscopic
  • Drug: 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
    Other Name: Esmeron
  • Drug: Rocuronium
    Intravenous use: 0,3 mg/kg followed by NaCl-infusion
    Other Name: Esmeron
  • Active Comparator: Deep neuromuscular blockade
    Intervention: Drug: Rocuronium
  • Placebo Comparator: Moderate neuromuscular blockade
    Intervention: Drug: Rocuronium
Staehr-Rye AK, Rasmussen LS, Rosenberg J, Juul P, Gätke MR. Optimized surgical space during low-pressure laparoscopy with deep neuromuscular blockade. Dan Med J. 2013 Feb;60(2):A4579.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
49
November 2012
November 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients older than 18 years
  • Scheduled for elective laparoscopic cholecystectomy
  • Can read and understand danish
  • Women must be post-menopausal, sterilized or use safe contraception in the form of a coil or oral anti-contraceptives

Exclusion Criteria:

  • Known allergy to medications that are included in the project
  • Presence of severe renal disease, neuromuscular disease, reduced liver function
  • Nursing or pregnant
  • Indication for crash induction
  • For fertile women: Missing negative pregnancy-test
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT01523886
2011-441
Yes
Not Provided
Not Provided
Anne Kathrine Staehr-Rye, Herlev Hospital
Herlev Hospital
Not Provided
Principal Investigator: Anne K Staehr, MD Department of anesthesia, Herlev Hospital, Denmark
Study Chair: Mona R Gätke, MD, Ph.D Department of anesthesia, Herlev Hospital
Herlev Hospital
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP