The Muscle Relaxation-study

Cholecystectomy, Laparoscopic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01523886
• Other study ID #: 2011-441
• Status: Completed
• Phase: Phase 4
• First received: January 19, 2012
• Last updated: March 16, 2014
• Start date: March 2012
• Est. completion date: November 2012

Study information

• Verified date: March 2014
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection AgencyDenmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cholecystectomy, Laparoscopic

Intervention

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

Locations

Country	Name	City	State
Denmark	Department of anesthesia and department of gastro-intestinale diseases, Aleris-Hamlet	Soeborg

Sponsors (1)

Lead Sponsor	Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	No
Secondary	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.	No
Secondary	Surgical Space Conditions	The surgical space conditions during dissection of the gallbladder (4-stage scale and VAS 0-100).	During dissection of the gallbladder	No
Secondary	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	No
Secondary	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	No
Secondary	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.	No
Secondary	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.	No
Secondary	Duration of Surgery	Duration of surgery	From surgical incision to last suture has been placed.	No
Secondary	Duration of Anesthesia	Duration of anesthesia	From induction of anesthesia to patient ready to leave the operating theatre	No
Secondary	Consumption of Analgesics	Consumption of analgesics during the first 24 hours after surgery	The first 24 hours after surgery	No
Secondary	Nausea and Vomiting	The incidence of nausea and vomiting during the first 24 hours after surgery	The first 24 hours after surgery	No
Secondary	Anti-emetics	Use of anti-emetics during the first 24 hours after surgery	During the first 24 hours after surgery	No