Efficacy and Safety of Optimal Muscle Tension Management During Laparoscopic Cholecystectomy - a Prospective Randomized Control Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Surgical condition
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
Single Blind
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 20~80 years old
- •ASA score : 1-2
- •Regular laparoscopic cholecystectomy
排除标准
- •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
研究组 & 干预措施
Group OMT
Optimal muscle tension management
干预措施: Optimal muscle tension management (Other)
Group Control
Conventional anesthetic management
结局指标
主要结局
Surgical condition
时间窗: 5 minutes
Surgeon describe CO2 inflation condition by 4 point King Score (1-4). 1. excellent 2. good 3. acceptable 4. poor or unacceptable
次要结局
- Pain score at Postoperative room(1 hour)
- Heart Rate(every 5 mins)
- Peak inspiratory pressure during surgery(1 hour)
- Mean blood pressure(Every 5 mins)
- Total surgical time(1 hour)
- Total Rocuronium doses during surgery(1 hour)
- Respiratory complications(Every 5 mins)