Use of Dexmedetomidine in Children Undergoing Cardiac Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- mechanical ventilation time
研究概览
简要总结
The aim of the study is to evaluate the efficacy of dexmedetomidine in reducing the need for sedatives and analgesics in the immediate post-operative period in children who underwent surgical correction of complex congenital heart disease
详细描述
The hypothesis the investigators want to verify is that the reduced administration of sedative drugs (opioids and benzodiazepines) in children undergoing cardiac surgery, reduces the side effects of the drugs themselves, such as respiratory depression (reduction of mechanical ventilation) and the onset of withdrawal symptoms while maintaining an adequate analgo-sedation.
The study is an unblinded randomized controlled study. It will involve 60 children aged > 1 and < 24 months sedated and mechanically ventilated after corrective or palliative surgery of congenital heart disease on cardiopulmonary bypass with Aristotle score > 8.
Dexmedetomidine infusion will be started upon arrival in the CICU and continued until the time of discontinuation of morphine.
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
- None
入排标准
- 年龄范围
- 1 Month 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age < 24 months but > 30 days, Aristotle score >8, elective procedures in cardiopulmonary bypass -
排除标准
- •atrioventricular block prior to the start of infusion; vasoactive inotropic score on arrival to the CICU>30; brain malformations orbone, muscle or neuromuscolar disease; pleural effusion or pneumothorax prior to the study; hepatic or renal failure
研究组 & 干预措施
cases
children who receive midazolam 0.05 mg/kg/h + morphine 10 mcg/kg/h + dexmedetomidne 0.5 mcg/kg/h. Midazolam in administered until extubation, while morphine and dexmedetomidine are administered until removal of surgical drains.
干预措施: dexmedetomidine (Drug)
结局指标
主要结局
mechanical ventilation time
时间窗: participants will be followed for the duration of ICU stay, an expected average of 5 days
To evaluate the efficacy of dexmedetomidine, administered in combination with midazolam and morphine, in reducing the time of mechanical ventilation, due to lower consumption of opioids and hypnotics and subsequent reduction of respiratory depression
次要结局
- analgo-sedation level(participants will be followed for the duration of ICU stay, an expected average of 5 days)
- withdrawal symptoms(participants will be followed for the duration of ICU stay, an expected average of 5 days)
- safety of dexmedetomidine infusion as a measure of systemic pressure decrease(participants will be followed for the duration of ICU stay, an expected average of 5 days)
研究者
Cristiana Garisto
physician
Bambino Gesù Hospital and Research Institute