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临床试验/CTRI/2025/01/078947
CTRI/2025/01/078947尚未招募4 期

Effectiveness of low dose intravenous dexmedetomidine,ketamine and nalbuphine in preventing emergence agitation after sevoflurane anaesthesia in children undergoing Adenotonsillectomy, A randomized controlled trial

Aarupadai veedu medical college and hospital1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2025年1月28日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
75
试验地点
1
主要终点
To evaluate the effectiveness of low dose intravenous Dexmedetomidine, Ketamine and Nalbuphine in preventing emergence agitation by assessing pediatric anesthesia emergence delirium (PAED) score after extubation in postoperative period.

研究概览

简要总结

One of the most common problem in children receiving Sevoflurane based anaesthesia while undergoing Adenotonsillectomy is emergence agitation. It can induce potential problems in children such as self injury, disconnection of the intravenous line , cough, stridor and bleeding which can cause difficulties for medical staff and serious anxiety for family members in the postoperative period. In our study we are going to evaluate the effectiveness of low dose intravenous Dexmedetomidine versus Nalbuphine versus Ketamine for the prevention of Emergence agitation.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
3.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • ASA grade I and II Age 3 to 10 years weight 15 to 35 kg Duration of procedure 60 to 90 minutes.

排除标准

  • Physical developmental delay Consent refusal from parents Bleeding disorders.

结局指标

主要结局

To evaluate the effectiveness of low dose intravenous Dexmedetomidine, Ketamine and Nalbuphine in preventing emergence agitation by assessing pediatric anesthesia emergence delirium (PAED) score after extubation in postoperative period.

时间窗: 4 hours

次要结局

  • To observe complications like postoperative nausea and vomiting, Bradycardia, Coughing, Laryngospasm(4 hours)
  • To monitor hemodynamics intraoperatively , at extubation and postoperatively.(15 minutes)
  • To measure and compare sedation post operatively using Ramsay Sedation scale(10 minutes)
  • To assess post operative Analgesic effect using Face, Leg, Activity, Cry and Consolability (FLACC) scale(10 minutes)

研究者

发起方
Aarupadai veedu medical college and hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Chandra Prithwish Prawir

Aarupadai veedu medical college and hospital

研究点 (1)

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