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
49
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
Intravenous use: 0,3 mg/kg followed by NaCl-infusion
Department of anesthesia and department of gastro-intestinale diseases, Aleris-Hamlet
Soeborg, Denmark
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
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
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Pain
Pain (shoulder, incision, deeop abdominal and general) at arrival to the postanesthesia care department, 2 hours and 1 day after surgery.
Time frame: 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
Time frame: 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
Time frame: From surgical incision to last suture has been placed, an expected average of 30 minutes.
Duration of Surgery
Duration of surgery
Time frame: From surgical incision to last suture has been placed.
Duration of Anesthesia
Duration of anesthesia
Time frame: 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
Time frame: The first 24 hours after surgery
Nausea and Vomiting
The incidence of nausea and vomiting during the first 24 hours after surgery
Time frame: The first 24 hours after surgery
Anti-emetics
Use of anti-emetics during the first 24 hours after surgery
Time frame: During the first 24 hours after surgery