The Muscle Relaxation-study
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|ClinicalTrials.gov Identifier: NCT01523886|
Recruitment Status : Completed
First Posted : February 1, 2012
Results First Posted : April 21, 2014
Last Update Posted : April 21, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Cholecystectomy, Laparoscopic||Drug: Rocuronium||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Optimization of Surgical Conditions During Laparoscopic Cholecystectomy With Deep or Moderate Neuromuscular Blockade|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||November 2012|
|Active Comparator: Deep neuromuscular blockade||
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
|Placebo Comparator: Moderate neuromuscular blockade||
Intravenous use: 0,3 mg/kg followed by NaCl-infusion
Other Name: Esmeron
- 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 (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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01523886
|Department of anesthesia and department of gastro-intestinale diseases, Aleris-Hamlet|
|Soeborg, Denmark, 2860|
|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|