The Muscle Relaxation-study

Herlev Hospital

Status and phase: Completed; Phase 4

Conditions: Cholecystectomy, Laparoscopic

Treatments: Drug: Rocuronium

Study type: Interventional

Funder types: Other

Identifiers

NCT01523886

2011-441

Details and patient eligibility

About

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.

Full 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.

Enrollment: 49 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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49 participants in 2 patient groups, including a placebo group

Deep neuromuscular blockade

Active Comparator group

Treatment:

Drug: Rocuronium

Drug: Rocuronium

Moderate neuromuscular blockade

Placebo Comparator group

Treatment:

Drug: Rocuronium

Drug: Rocuronium