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临床试验/NCT07799311
NCT07799311招募中4 期

Comparison of Propofol and Dexmedetomidine in Prevention of Emergence Agitation After Sevoflurane Anesthesia Following Inguinal Hernia Repair: A Randomized Control Trial

Pakistan Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2026年8月28日最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

干预措施: propofol 1mg/kg (Drug)

group dexmedetomidine

Active Comparator

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

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Muhammad Haroon Anwar

Principal investigator

Pakistan Institute of Medical Sciences

研究点 (1)

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