The Muscle Relaxation-study

Herlev Hospital49 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Cholecystectomy, Laparoscopic

Interventions

RocuroniumDRUG

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

RocuroniumDRUG

Intravenous use: 0,3 mg/kg followed by NaCl-infusion

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of anesthesia and department of gastro-intestinale diseases, Aleris-Hamlet

Soeborg, Denmark

Outcomes

Primary Outcomes

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

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.

Time frame: From surgical incision to last suture has been placed, an expected average of 30 minutes

Secondary Outcomes

Surgical Space Conditions

The surgical space conditions (VAS 0-100) assessed at the time during surgery, when they were poorest

Time frame: From surgical incision to last suture has been placed, an expected average of 30 minutes.

Surgical Space Conditions

The average surgical space conditions (VAS 0-100 and 4-stage scale) during the procedure.

Time frame: From surgical incision to last suture has been placed, an expected average of 30 minutes.

Surgical Space Conditions

The surgical space conditions during dissection of the gallbladder (4-stage scale and VAS 0-100).

Time frame: During dissection of the gallbladder

Pain

Pain (shoulder, incision, deep abdominal and general) as the area under the curve from preoperatively to 7 days after surgery.

Time frame: Preoperatively to 7 days after surgery

Data from ClinicalTrials.gov

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