Comparative study between sugammadex and neostigmine to evaluate hemodynamic response during reversal of rocuronium in patient undergoing craniotomy surgery: a randomised double blind controlled trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To compare the hemodynamic response Heart rate,SBP,DBP,MAP,SPO2 of sugammadex versus Neostigmine in reversal of rocuronium in pateints undergoing craniotomy surgery.
研究概览
简要总结
A total of 90 patients posted for elective craniotomy surgery and randomly divided into two equal groups (45each).we will compare the hemodynamic response of Sugammadex versus Neostigmine (Group S:sugammadex 2mg/kg versus Group N: neostigmine 50microgram/kg plus glycopyrrolate 10microgram/kg) in reversal of rocuronium.primary objective will be to compare the hemodynamic response(HR ,SBP,DBP,MAP,SPO2,) of sugammadex versus neostigmine in reversal of rocuronium in patients undergoing craniotomy surgery. secondary objective will be to evaluate side effects (PONV) and train of four response of sugammadex versus neostigmine in reversal of rocuronium in patients undergoing craniotomy surgery.we will record HR,SBP,DBP,MAP.SPO2,PONV,TOF at 2min,5min,10min,15min,30min,60min,2hr,6hr,12hr,18hr and 24hr.
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
- •All pateints age group 18-65years with craniotomy surgeries and giving written informed consent.
- •ASA GRADE 1 TO 3.
排除标准
- •1.Pateint refuse to participate.
- •2.Renal,Hepatic,Ventilatory Dysfunction.
- •3.Increased intracranial pressure.
- •4.Pregnancy or lactation.
- •5.Pateints with muscular dystrophies,myopathy,or cerebral palsy.
- •6.Pateints with a history of intolerance to any of the study drugs.
结局指标
主要结局
To compare the hemodynamic response Heart rate,SBP,DBP,MAP,SPO2 of sugammadex versus Neostigmine in reversal of rocuronium in pateints undergoing craniotomy surgery.
时间窗: 2min,5min,10min,15min,30min,60min,2hr,6hr,12hr,18hr,24hr.
次要结局
- 1.To evaluate the side effects (PONV) of sugammadex versus neostigmine in reversal of rocuronium in pateints undergoing craniotomy surgery.(2.To evaluate the Train of four Response of sugammadex versus neostigmine in reversal of rocuronium in pateints undergoing craniotomy surgery.)
研究者
DR KIRTI VERMA
Indira Gandhi Institute of Medical Sciences,Patna