The Muscle Relaxation-study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Optimization of Surgical Conditions During Laparoscopic Cholecystectomy With Deep or Moderate Neuromuscular Blockade

Conditions
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Cholecystectomy, Laparoscopic

Intervention / Treatment
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* Drug: Rocuronium
* Drug: Rocuronium


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Deep neuromuscular blockade<br> | Drug: Rocuronium<br>* 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<br>* Other names: Esmeron;|
| Placebo Comparator: Moderate neuromuscular blockade<br> | Drug: Rocuronium<br>* Intravenous use: 0,3 mg/kg followed by NaCl-infusion<br>* Other names: Esmeron;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From surgical incision to last suture has been placed, an expected average of 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical Space Conditions | The surgical space conditions (VAS 0-100) assessed at the time during surgery, when they were poorest | 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. | 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). | 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. | Preoperatively to 7 days after surgery | 
| Pain | Pain (shoulder, incision, deeop abdominal and general) at arrival to the postanesthesia care department, 2 hours and 1 day after surgery. | At arrival to the postanesthesia care department, 2 hours and 1 day after surgery | 
| Normal Functional Level | Numer of days before re-establing normal functional level | from the day of surgery to re-establishing normal functional level - an expected average of 7 days. | 
| Surgical Procedures at Low Pneumoperitoneum | Number of procedures which can be done with pneumoperitoneum 8 mmHg | From surgical incision to last suture has been placed, an expected average of 30 minutes. | 
| Duration of Surgery | Duration of surgery | From surgical incision to last suture has been placed. | 
| Duration of Anesthesia | Duration of anesthesia | From induction of anesthesia to patient ready to leave the operating theatre | 
| Consumption of Analgesics | Consumption of analgesics during the first 24 hours after surgery | The first 24 hours after surgery | 
| Nausea and Vomiting | The incidence of nausea and vomiting during the first 24 hours after surgery | The first 24 hours after surgery | 
| Anti-emetics | Use of anti-emetics during the first 24 hours after surgery | During the first 24 hours after surgery |