Comparative Efficacy and Safety of Fixed-Dose of 200 mg Versus Weight-Based 4 mg/kg Sugammadex for Reversal of Deep Neuromuscular Blockade in Adult Patients Undergoing Elective Surgery— A Randomized, controlled trial”
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Time in seconds from completion of study drug injection to first documented time of recovery of TOF Ratio of more than 0.80 and 0.90 at adductor pollicis measured by quantitative neuromuscular monitor.
研究概览
简要总结
This study is being done to compare the efficacy and safety of two different doses of sugammadex to reverse the effect of muscle paralysis of the patient at the end of surgery and the doses are fixed most commonly used dose of 200 mg with weight based dose calculation by 4 mg per kg . The effect of the drug will be noted with the help of neuromuscular transmission device with the help of adductor policis muscle and ulnar nerve . The time to achieve TOF Ratio of 0.8 and 0.9 will be noted with adverse event and cost analysis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 18 to 75 years.
- •ASA physical status I to III.
- •Elective surgical procedure under general anaesthesia with planned use of continuous infusion/boluses of vecuronium resulting in deep block at end of procedure.
- •Intraoperative confirmation of deep block at time of reversal attempt(TOF count = 0 with 1 to 2 posttetanic counts PTC).
- •Ability to provide written informed consent.
排除标准
- •age less tha 18 years and more than 75 years pregnant and lactating females liver and renal failure obese patients neuromuscular disorder.
结局指标
主要结局
Time in seconds from completion of study drug injection to first documented time of recovery of TOF Ratio of more than 0.80 and 0.90 at adductor pollicis measured by quantitative neuromuscular monitor.
时间窗: Time in seconds from completion of study drug injection to first documented time of recovery of TOF Ratio of more than 0.80 and 0.90 at adductor pollicis measured by quantitative neuromuscular monitor.
次要结局
- Proportion of patients achieving TOFR more than 0.90 within 3 min and within 3 to 5 min.
- Adverse events like allergic reactions, bradycardia , hypotension, arrhythmias, anaphylaxis, residual blockade.
- Cost analysis by calculating number of 200mg vials used per patient and estimated drug cost difference.
研究者
DR ABHA SINGH
United institute of medical sciences Prayagraj