Dose-effect of Propofol for Anesthetic Induction: Double-blind Comparison of Different Propofol Formulations Administered Alone or With Remifentanil
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Hopital Foch
- 入组人数
- 409
- 试验地点
- 2
- 主要终点
- necessary dose of propofol to obtain the induction of anesthesia (defined by a bispectral index < 60 over 30 continuous seconds)
研究概览
简要总结
The objective of this study is to evaluate the influence of different propofol formulations (plain or with remifentanil) on anesthetic induction. Propofol plain or with remifentanil is administered using a closed-loop algorithm in order to reach a Bispectral Index target of 50.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Patients scheduled for an intravenous induction of anesthesia with propofol
排除标准
- •Age under 18
- •Pregnancy or breastfeeding
- •Allergy to propofol, soya or peanuts,
- •Allergy to remifentanil,
- •History of central neurological disorder or brain injury,
- •Patients receiving psychotropic drugs,
- •Patient with a pacemaker
研究组 & 干预措施
propofol 1% (Astra-Zeneca) - remi 0
propofol 1% (Astra-Zeneca)plus remifentanil 0 ng/ml
干预措施: Propofol (Astra-Zeneca), NaCl 0.9% (Drug)
propofol 1% (Astra-Zeneca) - remi 2
propofol 1% (Astra-Zeneca)plus remifentanil 2 ng/ml
干预措施: propofol 1% (Astra-Zeneca) and remifentanil (Drug)
propofol 1% (Astra-Zeneca) - remi 4
propofol 1% (Astra-Zeneca)plus remifentanil 4 ng/ml
干预措施: propofol 1% (Astra-Zeneca) and remifentanil (Drug)
propofol 1% (Fresenius) - remi 0
propofol 1% (Fresenius) plus remifentanil 0 ng/ml
干预措施: Propofol (Astra-Zeneca), NaCl 0.9% (Drug)
propofol 1% (Fresenius) - remi 2
propofol 1% (Fresenius) plus remifentanil 2 ng/ml
干预措施: Propofol (Astra-Zeneca) and remifentanil (Drug)
propofol 1% (Fresenius) - remi 4
propofol 1% (Fresenius) plus remifentanil 4 ng/ml
干预措施: Propofol (Astra-Zeneca) and remifentanil (Drug)
propofol 1% (B-Braun) - remi 0
propofol 1% (B-Braun) plus remifentanil 0 ng/ml
干预措施: Propofol (B-Braun) and NaCl 0.9% (Drug)
propofol 1% (B-Braun) - remi 2
propofol 1% (B-Braun) plus remifentanil 2 ng/ml
干预措施: Propofol (B-Braun) and remifentanil (Drug)
propofol 1% (B-Braun) - remi 4
propofol 1% (B-Braun) plus remifentanil 4 ng/ml
干预措施: Propofol (B-Braun) and remifentanil (Drug)
结局指标
主要结局
necessary dose of propofol to obtain the induction of anesthesia (defined by a bispectral index < 60 over 30 continuous seconds)
时间窗: one hour after anesthesia
次要结局
- pain at injection(one hour after anesthesia)
- patient's satisfaction(one day after anesthesia)
- calculated concentrations of propofol at the end of the anesthetic induction(one hour after anesthesia)
- Disappearance of the eyelash reflex(One hour after anesthesia)
- heart rate modifications induced by anesthetic induction(one hour after anesthesia)
- arterial pressure modifications induced by anesthetic induction(one hour after anesthesia)