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临床试验/CTRI/2024/11/076689
CTRI/2024/11/076689尚未招募3 期

Efficacy of Dexmedetomidine compared to Midazolam for sedation in mechanically ventilated patients in Pediatric Intensive Care Unit- A Randomized Controlled Trial

Intramural research funds JIPMER1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2024年11月18日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
180
试验地点
1
主要终点
Efficacy of sedation

研究概览

简要总结

We wish to test the efficacy of dexmedetomidine vs midazolam infusions for sedation of mechanically ventilated children in PICU, JIPMER. All children who meet inclusion criteria, after consent, will be started on either dexmedetomidine or midazolam infusion for sedation, and infusions will be prepared in such a way that dosing range will be 0.3-1.5 mcg/kg/hour for dexmedetomidine, and 1-5 mcg/kg/min for midazolam. Infusions will be prepared in such a way that this will correspond to 1-5 ml/hour rate for both drugs. Investigator, participants and outcome assessors will be blinded. Efficacy of sedation will be assessed using sedation scores every 6 hourly, and assessing the proportion of measurements, out of total measurements, when child was in adequate sedation. Means of the proportion between the two groups will be compared.

研究设计

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

入排标准

年龄范围
1.00 Month(s) 至 16.00 Year(s)(—)
性别
All

入选标准

  • Mechanically ventilated children in PICU.

排除标准

  • Children with raised intracranial pressure, HIE sequelae, refractory shock, bradycardia.

结局指标

主要结局

Efficacy of sedation

时间窗: 5 days

次要结局

  • Delirium, Bolus doses of sedoanalgesia, iatrogenic withdrawal syndrome, adverse effects(5 days)

研究者

发起方
Intramural research funds JIPMER
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Narayanan P

Professor, Pediatrics

研究点 (1)

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