The Muscle Relaxation-study

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

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.

Study Overview

• Status: Completed
• Conditions: Cholecystectomy, Laparoscopic
• Intervention / Treatment: Drug: Rocuronium; Drug: Rocuronium

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 Type: Interventional
• Enrollment (Actual): 49
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Soeborg, Denmark, 2860
    • Department of anesthesia and department of gastro-intestinale diseases, Aleris-Hamlet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Deep neuromuscular blockade	Drug: Rocuronium; 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; Other Names: Esmeron; Drug: Rocuronium; Intravenous use: 0,3 mg/kg followed by NaCl-infusion; Other Names: Esmeron
PLACEBO_COMPARATOR: Moderate neuromuscular blockade	Drug: Rocuronium; 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; Other Names: Esmeron; Drug: Rocuronium; Intravenous use: 0,3 mg/kg followed by NaCl-infusion; Other Names: Esmeron

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Herlev Hospital
• Investigators: Principal Investigator: Anne K Staehr, MD, Department of anesthesia, Herlev Hospital, Denmark; Study Chair: Mona R Gätke, MD, Ph.D, Department of Anesthesia, Herlev Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (ACTUAL): November 1, 2012
• Study Completion (ACTUAL): November 1, 2012

Study Registration Dates

• First Submitted: January 19, 2012
• First Submitted That Met QC Criteria: January 30, 2012
• First Posted (ESTIMATE): February 1, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): April 21, 2014
• Last Update Submitted That Met QC Criteria: March 16, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Neuromuscular Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Rocuronium
• Other Study ID Numbers: 2011-441