Comparision of the efficacy of two different doses of sugammadex for reversal of vecuronium induced neuromuscular blockage in patients posted for elective surgeries under general anesthesia
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To compare clinical recovery profile of two different dose of sugammadex in terms of time require for spontaneous eye opening, adequate tidal volume (5ml/kg) , hand grip for 5 seconds and time requires for extubation.
研究概览
简要总结
Sugammadex is novel drug launched in india for reversal of vecuronium induced neuromuscular blockage in patients undergoing general anesthesia,but there are very few studies available for it’s optimal dosing .In this study we compare the effectiveness of two minimal dosing of inj sugammadex.
In this study there will be two groups ,one will receive inj,sugammadex 1mg/kg dose and other will receive 2mg/kg dose, We will compare the clinical recovery profile of this two minimal doses .
Study design :A prospective, double blind study.
Study setting :Operation theatre, Sir Takhtasinhji Hospital, Bhavnagar.
Study duration :15 months
Duration of data collection :12 months
Sample size : Patients undergoing elective surgical procedure requiring general anesthesia on Tuesday and Friday during study duration period
Sampling method :Convenient sampling
Randomization :Patient will be allocated into one of the study group by computer generated random numbers
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Age 18 to 60 years 2 ASA grade 1 to 3 3 schedule for elective surgery under general anesthesia 4 Surgery duration less than 2 hours 5 BMI less than30.
排除标准
- •Suspected difficult intubation Significant hepatic and renal dysfunction Any suspected neuromuscular disorder Known or suspected family history of malignant hyperthermia Lactating or pregnant female.
结局指标
主要结局
To compare clinical recovery profile of two different dose of sugammadex in terms of time require for spontaneous eye opening, adequate tidal volume (5ml/kg) , hand grip for 5 seconds and time requires for extubation.
时间窗: At baseline,Immediate after Inj.sugammadex and after 5min,10min,15min,30min,60min,90 min,120min after Inj.sugammadex
次要结局
- 1. To compare the hemodynamic changes(Mean arterial pressure, Heart rate) after Inj. sugammadex(2. Side effects (If any) after Inj. sugammadex in both groups.)
研究者
Divyeshkumar Gajjar
GMC Bhavnagar gujarat