2024-516072-15-00招募中4 期
Propofol and Thiopental for intravenous induction in neonates: a dose-finding study (The ProThio Study)
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Loss of eyelash reflex and acceptance of facemask
研究概览
简要总结
To establish the effective dose 50% for the anesthetics propofol and thiopental for intravenous induction of anesthesia in newborns below the postmenstrual age of 47 weeks.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Neonates <47 weeks postmenstrual age (PMA) undergoing general anesthesia (GA) for any condition
排除标准
- •Allergies towards propofol or thiopental,
- •Known or family history of porphyria (thiopental only),
- •Parental refusal of insertion of an iv-line.,
- •sedation within last 24 hours,
- •Contraindication to propofol or thiopental according to the attending anesthesiologist, not mentioned above.
结局指标
主要结局
Loss of eyelash reflex and acceptance of facemask
Loss of eyelash reflex and acceptance of facemask
次要结局
未报告次要终点
研究者
Kristian Nørholm Jensen
Scientific
Odense University Hospital
研究点 (1)
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