Remifentanil and Propofol Versus Fentanyl and Midazolam for Sedation During Therapeutic Hypothermia. A Randomised, Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- time from termination of sedation to extubation in patients treated with therapeutic hypothermia, after treatment with the combination remifentanil and propofol versus that of fentanyl and midazolam.
研究概览
简要总结
The aim of this study is to increase knowledge about drug properties and effects during therapeutic hypothermia. The primary end point of this study is the time from termination of sedation to extubation in patients treated with therapeutic hypothermia, after treatment with the combination remifentanil and propofol versus that of fentanyl and midazolam.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Treatment with therapeutic hypothermia following cardiac arrest (33-34°C) and analgesia/sedation required
- •Patients must be 18 years or older
- •Inclusion must be approved by the attending physician
排除标准
- •Pregnant women
- •Cardiovascular unstable patients in a deteriorating circulatory status which require multiple other therapeutic measures that makes participation practically impossible
- •Liver or renal failure defined as sequential organ failure assessment (SOFA)-score 3 or 4
- •History of drug allergies, or contraindications for the study drugs
- •Patients using a scheduled dose of any of the study drugs.
- •Patients with a known substance abuse of opioids or benzodiazepines
研究组 & 干预措施
Study group 1
Midazolam and fentanyl; continuous intravenous infusions
干预措施: fentanyl and midazolam (Drug)
Study group 2
Propofol and remifentanil; continuous intravenous infusion
干预措施: remifentanil and propofol (Drug)
结局指标
主要结局
time from termination of sedation to extubation in patients treated with therapeutic hypothermia, after treatment with the combination remifentanil and propofol versus that of fentanyl and midazolam.
时间窗: 2010
次要结局
未报告次要终点