Efficacy and Safety of Optimal Muscle Tension Management During Laparoscopic Cholecystectomy

National Taiwan University Hospital Hsin-Chu Branch

Status: Unknown

Conditions: Anesthesia

Treatments: Other: Optimal muscle tension management

Study type: Interventional

Funder types: Other

Identifiers

NCT04165057

108-084-F

Details and patient eligibility

About

Our study is intended to compare optimal muscle tension management or conventional anesthetic management in laparoscopic cholecystectomy about surgical condition during the surgery and other conditions after surgery at POR.

Full description

This study is intended to recruit 70 patients undergoing laparoscopic cholecystectomy, whom will be randomized to receive optimal muscle tension management or conventional anesthetic management without optimal muscle tension management. Our primary hypothesis is that optimal muscle tension management provides improved surgical conditions and less intra-abdominal pressure required. The secondary endpoints include surgical duration, intraoperative complications, total amount of muscle relaxants, respiratory and hemodynamic changes during surgery, extubation time and any events during post-anesthetic recovery.

Enrollment: 70 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age 20~80 years old
• ASA score : 1-2
• Regular laparoscopic cholecystectomy

Exclusion criteria

• Renal function impairement (eGFR < 60 ml/min/1.73m2) or ESRD
• BMI < 18.5 kg/m2 or >30 kg/m2
• History of other abdominal surgery
• Allergy to rocuronium, cisatracurium, neostigmine or sugammadex
• Emergent surgery
• Convert to open cholecystectomy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

Group OMT

Active Comparator group

Description:

Optimal muscle tension management

Treatment:

Other: Optimal muscle tension management

Group Control

No Intervention group

Description:

Conventional anesthetic management