跳至主要内容
临床试验/CTRI/2025/08/093256
CTRI/2025/08/093256尚未招募不适用

Efficacy of dexmedetomidine versus midazolam plus fentanyl for sedation in mechanically ventilated children

UCMS and GTB Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年8月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
Percentage of time spent in level -3 to -4 of RASS

研究概览

简要总结

This study has been designed to assess the efficacy of dexmedetomidine compared to the conventional midazolam plus fentanyl regimen for sedation in mechanically ventilated children. Adequate sedation and analgesia are essential in mechanically ventilated children to reduce agitation, ensure safety, and synchronize breathing with the ventilator. Midazolam plus fentanyl is widely used but associated with adverse events including bradycardia and hypotension. Dexmedetomidine, an alpha 2 adrenergic agonist with both sedative and analgesic properties and minimal respiratory depression, shows promise as an alternative. There is paucity of data on use of dexmedetomidine as first line sedative during mechanical ventilation in children. Few studies have shown the role of dexmedetomidine in sedation in reducing time duration of sedation and extubation duration and results have been promising. Therefore, through this study, we propose to evaluate efficacy of dexmedetomidine in children on mechanical ventilation admitted in pediatric intensive care unit as compared to midazolam plus fentanyl.

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
1.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • All children aged between 1 year to 12 year, admitted in PICU and requiring mechanical ventilation.

排除标准

  • History of known allergy or reaction to dexmedetomidine or midazolam or fentanyl
  • Patients with neuro-paralytic disorder
  • Patients already on sedation
  • Patients with hepatic involvement.

结局指标

主要结局

Percentage of time spent in level -3 to -4 of RASS

时间窗: From enrollment to 48 hours of study

次要结局

  • Time to achieve -3 or -4 sedation level of RASS(From enrollment to time taken to achieve -3 or -4 level of RASS)
  • Number of additional boluses required(From enrollment to 48 hours of study)
  • Episodes of bradycardia, hypotension and any other adverse effect(From enrollment to 48 hours of study)

研究者

发起方
UCMS and GTB Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Unnati Sharma

University College of Medical Sciences and GTB hospital, Delhi

研究点 (1)

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