The Muscle Relaxation-study

NCT ID: NCT01523886

Last Updated: 2014-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2012-11-30

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.

Conditions

Cholecystectomy, Laparoscopic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Deep neuromuscular blockade

Group Type: ACTIVE_COMPARATOR

Rocuronium

Intervention Type: DRUG

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

Moderate neuromuscular blockade

Group Type: PLACEBO_COMPARATOR

Rocuronium

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Rocuronium

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

Intervention Type: DRUG

Other Intervention Names

Esmeron; Esmeron

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Herlev Hospital

OTHER

Sponsor Role: lead

Responsible Party

Anne Kathrine Staehr-Rye

Clinical research assistent

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anne K Staehr, MD

Role: PRINCIPAL_INVESTIGATOR

Department of anesthesia, Herlev Hospital, Denmark

Mona R Gätke, MD, Ph.D

Role: STUDY_CHAIR

Department of anesthesia, Herlev Hospital

Locations

Department of anesthesia and department of gastro-intestinale diseases, Aleris-Hamlet

Soeborg, , Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 23461992 (View on PubMed)

Other Identifiers

2011-441

Identifier Type: -

Identifier Source: org_study_id