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临床试验/CTRI/2025/02/080731
CTRI/2025/02/080731已完成不适用

Study to evaluate the effects of Inj Ketamine and Inj Dexmedetomidine for Sedation in Pediatric Middle Ear Cleft Surgery.

Dr Anil Kumar1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年2月28日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Compare level of Sedation achieved by Ramsay Sedation Scale Score

研究概览

简要总结

in this study dexmedetomidine is compared with ketamine for middle ear surgery in pediatric patients. when used alone they show some properties, but when used together they show additional benefits, which is studied with the help of Ramsay sedation scale as primary objective.

in secondary objectives, we look for the hemodynamic stability, requirement of rescue analgesia and occurrence  of any complication in both groups

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
6.00 Year(s) 至 14.00 Year(s)(—)
性别
All

入选标准

  • perforation of tympanic membrane.

排除标准

  • 1 congenital life threatening condition 2 IHD or other cardiac condition 3 chronic renal diseases 4 anemia and blood cancer 5 peripheral vascular disease.

结局指标

主要结局

Compare level of Sedation achieved by Ramsay Sedation Scale Score

时间窗: Baseline, 6 hours and 8 hours

次要结局

  • 1 Hemodynamic Changes(2 Rescue Analgesia)

研究者

发起方
Dr Anil Kumar
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Anil Kumar

Government Medical College, Jalaun( Orai)

研究点 (1)

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