Clinical trial NCT01523886: The Muscle Relaxation-study
Official title: Optimization of Surgical Conditions During Laparoscopic Cholecystectomy With Deep or Moderate Neuromuscular Blockade
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cholecystectomy, Laparoscopic
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2012-02-01
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: From surgical incision to last suture has been placed, an expected average of 30 minutes
Secondary outcomes:
measure: Surgical Space Conditions
timeFrame: From surgical incision to last suture has been placed, an expected average of 30 minutes.
measure: Surgical Space Conditions
timeFrame: From surgical incision to last suture has been placed, an expected average of 30 minutes.
measure: Surgical Space Conditions
timeFrame: During dissection of the gallbladder
measure: Pain
timeFrame: Preoperatively to 7 days after surgery
measure: Pain
timeFrame: At arrival to the postanesthesia care department, 2 hours and 1 day after surgery
measure: Normal Functional Level
timeFrame: from the day of surgery to re-establishing normal functional level - an expected average of 7 days.
measure: Surgical Procedures at Low Pneumoperitoneum
timeFrame: From surgical incision to last suture has been placed, an expected average of 30 minutes.
measure: Duration of Surgery
timeFrame: From surgical incision to last suture has been placed.
measure: Duration of Anesthesia
timeFrame: From induction of anesthesia to patient ready to leave the operating theatre
measure: Consumption of Analgesics
timeFrame: The first 24 hours after surgery
measure: Nausea and Vomiting
timeFrame: The first 24 hours after surgery
measure: Anti-emetics
timeFrame: During the first 24 hours after surgery
Other outcomes:
Locations:
city: Soeborg
country: Denmark
facility: Department of anesthesia and department of gastro-intestinale diseases, Aleris-Hamlet
Study officials:
affiliation: Department of anesthesia, Herlev Hospital, Denmark
name: Anne K Staehr, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of anesthesia, Herlev Hospital
name: Mona R Gätke, MD, Ph.D
role: STUDY_CHAIR
References:
citation: Staehr-Rye AK, Rasmussen LS, Rosenberg J, Juul P, Gatke MR. Optimized surgical space during low-pressure laparoscopy with deep neuromuscular blockade. Dan Med J. 2013 Feb;60(2):A4579.