Sevoflurane Versus Propofol for Intubation in Neonatal Intensive Care
试验速览
- 阶段
- 3 期
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- To compare recovery time between sevoflurane and propofol for intubation of neonates.
研究概览
简要总结
Endotracheal intubation is a painful and stressful procedure, which is associated with acute increases of blood pressure, intracranial pressure, bradycardia and hypoxemia with high morbidity.
The aim of the study is to compare recovery time, efficacy and tolerance in a randomized controlled study, between sevoflurane and propofol for intubation in neonates in Neonatal Intensive Care Unit.
详细描述
Background:
Endotracheal intubation is a painful and stressful procedure, which is associated with acute increases of blood pressure, intracranial pressure, bradycardia and hypoxemia with hight morbidity.
In 2001, in France more than 50% of intubations in neonates were performed without any premedication or anesthesia.
The most frequently used anesthesias are based on benzodiazepine or opioids. Unfortunately, these treatments are responsible for respiratory and hemodynamic adverse effects. Recently, 2 new possibilities for anesthesia before intubation has been tested: propofol was better than association of morphine, succinylcholine and atropine and we shaw that inhaled sevoflurane was better than no treatment.
The aim of the present study is to compare recovery time, efficacy and tolerance in a randomized controlled study, between sevoflurane and propofol for intubation in neonates in Neonatal Intensive Care Unit.
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
- — 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized in neonatal intensive care unit
- •Needing of an endotracheal intubation
排除标准
- •Emergency state
- •Predictable difficult endotracheal intubation
- •Decrease of blood pressure
- •Neurological disorders
- •Morphinic treatment
研究组 & 干预措施
Sevoflurane
Administration of sevoflurane (SEVORANE) by inhalation until a maximal concentration of 4% of inspired gas.
干预措施: Administration of sevoflurane (Drug)
Propofol
Administration of propofol (DIPRIVAN) by intravenous injection (1 mg/kg to turn over twice if necessary
干预措施: Administration of propofol (Drug)
结局指标
主要结局
To compare recovery time between sevoflurane and propofol for intubation of neonates.
时间窗: 18 months
次要结局
- To compare efficacy and tolerance between sevoflurane and propofol for intubation of neonates.(18 months)