Efficacy of dexmedetomidine versus midazolam plus fentanyl for sedation in mechanically ventilated children
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
Dr Unnati Sharma
University College of Medical Sciences and GTB hospital, Delhi
