Dexmedetomidine Sedation in Pediatric Intensive Care Unit
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- University of Michigan sedation scale
研究概览
简要总结
Dexmedetomidine is a highly selective α2-agonist with hypnotic, analgesic, and anxiolytic properties. Despite off-label administration, dexmedetomidine has found a niche in critically ill mechanically ventilated neonates and infants because of its minimal effects on respiratory function at sedative doses, facilitating early extubation and fast-track postoperative care.
详细描述
Critically ill children require sedation for comfort and to facilitate mechanical ventilation and interventions. The ideal sedative agent for use in critically ill children has to be effective and short-acting, of rapid onset of action, lacks active metabolites, does not accumulate in patients with renal or hepatic dysfunction, has minimal to no cardiovascular or respiratory adverse effects, and has few drug interactions.
Dexmedetomidine is a highly selective α2-agonist with hypnotic, analgesic, and anxiolytic properties. Despite off-label administration, dexmedetomidine has found a niche in critically ill mechanically ventilated neonates and infants because of its minimal effects on respiratory function at sedative doses, facilitating early extubation and fast-track postoperative care.
The only FDA approved indication of dexmedetomidine is sedation of intubated mechanically ventilated adults for less than 24h. However, the literature is full of many research studies that investigated the use off-lable use of dexmedetomidine for sedation more than 24h in both adult and pediatric population and proved its safety and effectiveness.
The aim of this study will be to investigate the safety and efficacy of dexmedetomidine in two different doses in sedation for critically ill mechanically ventilated infants with respiratory failure for 72h duration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Month 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants (1-12 months).
- •Respiratory failure/
- •Requiring PICU admission and mechanical ventilation up to 72h.
排除标准
- •Significant renal, hepatic, endocrine or metabolic disease.
- •2nd or 3rd degree heart block.
- •hypotension or bradycardia (defined as any value outside the normal range from the patient's age).
研究组 & 干预措施
DEX I 0.35µg/kg /h
the infants will receive a maintenance dose of 0.35µg/kg /h of Dexmedetomidne without a loading dose and guided by the assessed sedation scale
干预措施: Dexmedetomidine 0.35µg/kg /h (Drug)
DEX II 0.5µg/kg /h
the infants will receive a maintenance dose of 0.5µg/kg /h of Dexmedetomidne without a loading dose and guided by the assessed sedation scale.
干预措施: Dexmedetomidine 0.5µg/kg /h (Drug)
结局指标
主要结局
University of Michigan sedation scale
时间窗: 72H
The university of Michigan sedation scale (UMSS) will be assessed every hour
次要结局
- The blood pressure(72h)
- The heart rate(72h)
研究者
Hala Saad Abdel-Ghaffar
Assisstant professor in anesthesia and intensive care, Faculty of medicine, Assiut university, Egypt.
Assiut University