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临床试验/CTRI/2022/10/046610
CTRI/2022/10/046610尚未招募不适用

A comparative study of ketamine and dexmedetomidine versus ketamine and fentanyl for intravenous sedation in children undergoing infraumbilical surgeries under spinal anaesthesia

Vijayanagar institute of medical sciences1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年10月25日最近更新:
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试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1
主要终点
To compare quality of sedation by using Modified Observer’s Assessment Alertness/Sedation (MOAA/S) scale
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The aim of this randomized controlled trial study is to compare the effect of Ketamine -dexmedetomidine and ketamine-fentanyl combination as an IV sedation on analgesia, quality of intraoperative sedation, homodynamic changes and recovery characteristics in children undergoing infraumbilical surgeries under spinal anaesthesia.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant Blinded

入排标准

年龄范围
2.00 Year(s) 至 8.00 Year(s)（—）
性别
All

入选标准

  • •All ASA physical status 1 and 2,belonging to 2-8yr age group of either sex posted for elective infraumbilical sugeries.

排除标准

  • •(a)Parent’s refusal for the study (b)Children with any contraindication for spinal anaesthesia (c)Significant cardiovascular, respiratory, CNS, renal system and endocrinal disorders (d)Allergy to the study drugs.

结局指标

主要结局

To compare quality of sedation by using Modified Observer’s Assessment Alertness/Sedation (MOAA/S) scale

时间窗: From premedication to the recovery of patient from sedation

次要结局

  • To compare(1)Intraoperative hemodynamic changes)

研究者

申办方类型
Government medical college

研究点 (1)

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