Comparison of safety and efficacy of restricted use of muscle relaxant and TOF (Train of Four) based reversal with conventional use of muscle relaxant and reversal in laparoscopic cholecystectomy: A Prospective randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1. Feasibility of providing adequate surgical conditions by maintaining entropy of 40-50 and without dense neuromuscular blockade.
研究概览
简要总结
After ethics commitee approval and CTRI registration, This prospective randomised controlled trial will include 40 patients undergoing lap cholecystectomy under GA dividedinto 2 groups : Group F to receive weight based muscle relaxant and atracurium and fixed dose of neostigmine and group V : to receive restricted muscle relaxant anf TOF guided neostigmine. under entropy guidance. Intraop surgical conditionbs, airway pressure, muscle relant and neostigmine dose, extubation, recovery time, postop muscle grip strength, peak expiratory flow rate, situp, stan and postop pulmonary complications will be assessed
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA 1-2 , 18-65 yr age, both gender, BMI :18.5 to 27 kg/m2, Duration of surgery: 1hr to 3 hr Elective surgery.
排除标准
- •A history of myopathy, polyneuropathy, Severe kidney or liver diseases, Thyroid disorders, Myasthenia or stroke, Patients treated with amino glycosides or magnesium or any medication known to influence neuromuscular function, Unexpected difficult airway, Pregnancy, breastfeeding, Emergency surgery, Chronic obstructive pulmonary disease, CAD, Electrolyte imbalance, Intra operative airway complication-bronchospasm and aspiration.
结局指标
主要结局
1. Feasibility of providing adequate surgical conditions by maintaining entropy of 40-50 and without dense neuromuscular blockade.
时间窗: intraop
2. Comparison of surgical conditions and atracurium requirement between use of liberal dose of atracurium to achieve dense neuromuscular block (group F) and restricted use of atracurium while maintain adequate depth of anesthesia (group V)
时间窗: intraop
3. Comparison of dose of neostigmine for reversal of NMBD with a liberal dose of neostigmine administered based on clinical judgment with administration of neostigmine titrated to TOF ratio.
时间窗: intraop
次要结局
- 1. Comparison of maximum intra abdominal pressure, peak airway pressure at highest intra abdominal pressure, airway Compliance at highest intra abdominal pressure, requirement of isoflurane, requirement of intraoperative fentanyl between the groups.(2. Comparison of TOF ratio at the time of decision of reversal and time for extubation,)
研究者
Singam Geetha
Nizams Institute of Medical Sciences