A Prospective Randomized Study to Compare the Post operative side effects of sugammadex vs neostigmine for reversal of vecuronium-induced neuromuscular blockade in patients undergoing CORONARY ARTERY BYPASS GRAFTING off pump
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Time from reversal administration at least 3 TOFR equal to or more than 0.9
研究概览
简要总结
This prospective, randomized clinical study was designed to compare the postoperative side effects of sugammadex versus neostigmine in reversing vecuronium - induced neuromuscular blockade in patients undergoing off-pump coronary artery bypass grafting (CABG). Eligible patients were randomly allocated to receive either sugammadex or neostigmine at the end of surgery. The objectives of the study was time to onset of train of four from time of administration of reversal agents and evaluations of postoperative complications such as bradycardia, hypotension, nausea, vomiting, residual neuromuscular blockade, need for NIV support, need for reintubation ,cardiac arrest. The aim of the study was to determine safer and more effective reversal agent in context of CABG-off pump surgeries, where rapid and smooth recovery from neuromuscular blockade is critical.
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 90.00 Year(s)(—)
- 性别
- All
入选标准
- •18 years of age or older
- •Scheduled for elective cardiac surgery with general anesthesia, invasive mechanical ventilation, complete median sternotomy.
排除标准
- •Age less than 18 years
- •Patient scheduled for emergency or redo surgeries
- •Patients with history of COPD / Pulmonary hypertension / hepatic or renal dysfunction.
结局指标
主要结局
Time from reversal administration at least 3 TOFR equal to or more than 0.9
时间窗: 3 minutes / 5 minutes / 10 minutes / 20 minutes / 30 minutes / 1 hour / 2 hour
次要结局
- Time of extubation from discontinuation of inhaled anaesthetic,(Need for reintubation,)
研究者
Dr Kiran Muthu Rajah
Sri Ramachandra Institute of Higher Education and Research
