Comparative analysis of sugammadex versus neostigmine as an effective reversal agent in paediatric abdominal and urogenital surgeries under general anaesthesia. A randomised control study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AIIMS
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Time from start of administration of sugammadex/ neostigmine to recovery of the T4/T1 ratio to 0.9
研究概览
简要总结
This randomised control study will compare the effectiveness and adverse effects of the two reversal agents sugammadex and neostigmine for reversing neuromuscular blockade induced with rocuronium undergoing abdominal and urogenital surgeries under general anaesthesia. Paediatric patients between age 2-12 years will be divided into two groups and both groups to be given rocuronium as muscle relaxant and after completion of surgery TOF monitoring should be done to assess the neuromuscular blockade and one of the two reversing agents to be used in each group and time to recovery of neuromuscular block and adverse effects compared. Also the GCS and MRC will be compared in the post operative period to compare the efficacies of each drug.
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
- 2.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Abdominal surgeries Urogenital surgeries ASA 1&2 General anaesthesia.
排除标准
- •Not willing for consent Developmental delay Known history of drug allergy Diseases affecting neuromuscular junction or malignant hyperthermia Kidney / liver failure.
结局指标
主要结局
Time from start of administration of sugammadex/ neostigmine to recovery of the T4/T1 ratio to 0.9
时间窗: At reappearance of T2
次要结局
- Number of participants with clinical signs of recovery assessed by GCS and MRC.(At intervals of 15 mins, 30 mins, 1 hr and 2 hrs in Post anaesthesia care unit.)
研究者
Preeti Prasasya Sahoo
All India Institute of Medical Sciences, Raipur