Comparative Efficacy Of Sugammadex Versus Neostigmine in Reversal Of Vecuronium Induced Moderate Neuromuscular Blockade in patients undergoing surgery under General anesthesia in a tertiary care hospital - A double blinded randomized controlled trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- To compare the incidence of post operative residual neuromuscular paralysis with
研究概览
简要总结
This study is a randomised, double blinded, controlled trial comparing the efficacy of Sugammadex Versus Neostigmine in Reversal Of Vecuronium Induced Moderate Neuromuscular Blockade in patients undergoing surgery under General anesthesia in a tertiary care hospital on 84 participants. The primary objective is to compare the incidence of post-operative residual neuromuscular paralysis with sugammadex or neostigmine during vecuronium induced moderate neuromuscular blockade with Train of Four (TOF) monitoring in patients undergoing surgery under general anesthesia. The secondary objective is to compare the time from the start of administration of sugammadex or neostigmine to recovery of the Train of Four (TOF) ratio to 0.9 , to compare the baseline Forced expiratory volume (FEV1) and Peak expiratory flow rate (PEFR) values and post-operative Forced expiratory volume (FEV1) and Peak expiratory flow rate (PEFR) after arrival to Post anaesthesia care unit (PACU) and to record adverse events in both the groups until discharge from Post anaesthesia care unit (PACU)
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged between 18 to 60yrs, Patients belonging to ASA class I and II.
排除标准
- •Significant kidney disease (stage 4 kidney disease or higher), Significant liver disease (aspartate aminotransferase [AST] or alanine aminotransferase[ALT] more than twice the upper limit of normal), Emergency surgeries under general anaesthesia, Patients requiring post operative mechanical ventilation, Difficult airway, Pregnancy/Breastfeeding, Known case of neuromuscular disorder, Allergies to study drugs.
结局指标
主要结局
To compare the incidence of post operative residual neuromuscular paralysis with
时间窗: 1 year
sugammadex or neostigmine during vecuronium induced moderate neuromuscular blockade with Train of Four (TOF) monitoring in patients undergoing surgery under general anesthesia
时间窗: 1 year
次要结局
- To compare the time from the start of administration of sugammadex or neostigmine to(recovery of the Train of Four (TOF) ratio to 0.9)
- To compare the baseline Forced expiratory volume (FEV1) and Peak expiratory flow(rate (PEFR) values and post-operative Forced expiratory volume (FEV1) and Peak)
- To record adverse events in both the groups until discharge from Post anaesthesia care unit (PACU)(1 year)
研究者
S SIVAKUMAR
Pondicherry Institute of Medical Sciences