Efficacy and Safety of Optimal Muscle Tension Management During Laparoscopic Cholecystectomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy and Safety of Optimal Muscle Tension Management During Laparoscopic Cholecystectomy - a Prospective Randomized Control Study

Conditions
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Anesthesia

Intervention / Treatment
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* Other: Optimal muscle tension management


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group OMT<br>Optimal muscle tension management | Other: Optimal muscle tension management<br>* including TOF monitor and reversal of neuromuscular blockade agent : sugammadex<br>|
| No Intervention: Group Control<br>Conventional anesthetic management | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical condition | Surgeon describe CO2 inflation condition by 4 point King Score (1-4). excellent good acceptable poor or unacceptable | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak inspiratory pressure during surgery | Peak inspiratory pressure during surgery | 1 hour | 
| Mean blood pressure | Mean blood pressure during the CO2 inflation | Every 5 mins | 
| Total surgical time | Total surgical time | 1 hour | 
| Total Rocuronium doses during surgery | Total Rocuronium doses during surgery | 1 hour | 
| Pain score at Postoperative room | describe by 11 points Numeric rating scales (0-10). From 0 which means no pain to 10 means worst pain | 1 hour | 
| Heart Rate | Every beat per minutes heart rate during CO2 inflation | every 5 mins | 
| Respiratory complications | Record any respiratory complications including desaturations (<95%, more than 30 seconds, Rispiratory rate < 8), aspiration or airway obstruction | Every 5 mins | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopic surgery, Optimal muscle tension, Neuromuscular monitoring, Neuromuscular blockade, Sugammadex