Comparison of Propofol and Dexmedetomidine in Prevention of Emergence Agitation After Sevoflurane Anesthesia Following Inguinal Hernia Repair: A Randomized Control Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Emergence Delirium PAED score
研究概览
简要总结
This is a clinical study for comparing the efficacy of two drugs i.e propofol and dexmedetomidine in prevention of a group of post operative abnormal behaviours that can occur after sevoflurane anesthesia in children and we will measure this by a special scale which is used to evaluate these behavioural changes.
详细描述
A randomized clinical trial in which we will compare a single dose propofol with a single dose of dexmedetomodine given at the end of surgery after sevoflurane _based anesthesia to prevent post operative emergence agitation which is a group of behaviours consisting of confusion , disorientation,hyperactivity and even physical harm to themselves and others. this behavioural response is assessed by a score which is called peadriatric anesthesia emergence delerium scale (PEAD) which consist of 5-itms and 5-point scale ,ranging from not at all to extremely.the total score range from 0 to 20,with higher scores indicating more svere emergence agitation . In this study , the PEAD score will be recorded at 0,5,10,15,and 30 minutes after the child reach the recovery room ,and score greater than 10 at any of these readings will be taken as emergence agitation or delerium.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 12 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1- age 2-12 years 2-elective inguinal hernia repair under general anesthesia
排除标准
- •congenital anomalies
- •allergic to study medications
- •chronic pain syndromes
- •malnourishment -
研究组 & 干预措施
Group propofol
干预措施: propofol 1mg/kg (Drug)
group dexmedetomidine
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Emergence Delirium PAED score
时间窗: PAED score will be calculated upon arrival in Post Anesthesia care unit then at 5,10,15,30 minutes interval
次要结局
未报告次要终点
研究者
Muhammad Haroon Anwar
Principal investigator
Pakistan Institute of Medical Sciences
