Anesthesia
Conditions
Keywords
Laparoscopic surgery, Optimal muscle tension, Neuromuscular monitoring, Neuromuscular blockade, Sugammadex
Brief summary
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
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.
Interventions
OTHEROptimal muscle tension management
including TOF monitor and reversal of neuromuscular blockade agent : sugammadex
Sponsors
National Taiwan University Hospital Hsin-Chu Branch
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
Single Blind
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical condition | 5 minutes | Surgeon describe CO2 inflation condition by 4 point King Score (1-4). 1. excellent 2. good 3. acceptable 4. poor or unacceptable |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean blood pressure | Every 5 mins | Mean blood pressure during the CO2 inflation |
| Total surgical time | 1 hour | Total surgical time |
| Total Rocuronium doses during surgery | 1 hour | Total Rocuronium doses during surgery |
| Peak inspiratory pressure during surgery | 1 hour | Peak inspiratory pressure during surgery |
| Heart Rate | every 5 mins | Every beat per minutes heart rate during CO2 inflation |
| Respiratory complications | Every 5 mins | Record any respiratory complications including desaturations (\<95%, more than 30 seconds, Rispiratory rate \< 8), aspiration or airway obstruction |
| Pain score at Postoperative room | 1 hour | describe by 11 points Numeric rating scales (0-10). From 0 which means no pain to 10 means worst pain |
Countries
Taiwan
Contacts
Primary ContactYI-PING WANG, MD
Outcome results
None listed