The Muscle Relaxation-study

Phase 4

Completed

• Conditions: Cholecystectomy, Laparoscopic
• Interventions: Drug: Rocuronium

• Registration Number: NCT01523886
• Lead Sponsor: Herlev Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2012-01-19
• Study First Submitted QC: 2012-01-30
• Study First Posted: 2012-02-01
• Study Start: 2012-03
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Results First Submitted: 2014-01-16
• Status Verified: 2014-03
• Results First Submitted QC: 2014-03-16
• Last Update Submitted: 2014-03-16
• Results First Posted: 2014-04-21
• Last Update Posted: 2014-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Deep neuromuscular blockade	Rocuronium	-
Moderate neuromuscular blockade	Rocuronium	-

Primary Outcome Measures

Name	Time	Method
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	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.

Secondary Outcome Measures

Name	Time	Method
Surgical Space Conditions	During dissection of the gallbladder	The surgical space conditions during dissection of the gallbladder (4-stage scale and VAS 0-100).
Pain	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	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	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	From surgical incision to last suture has been placed.	Duration of surgery
Duration of Anesthesia	From induction of anesthesia to patient ready to leave the operating theatre	Duration of anesthesia
Consumption of Analgesics	The first 24 hours after surgery	Consumption of analgesics during the first 24 hours after surgery
Nausea and Vomiting	The first 24 hours after surgery	The incidence of nausea and vomiting during the first 24 hours after surgery
Anti-emetics	During the first 24 hours after surgery	Use of anti-emetics during the first 24 hours after surgery

Trial Locations

Locations (1)

Department of anesthesia and department of gastro-intestinale diseases, Aleris-Hamlet; 🇩🇰 Soeborg, Denmark