Dose-effect of Propofol for Anesthetic Induction: Double-blind Comparison of Different Propofol Formulations Administered Alone or With Lidocaine
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Hopital Foch
- 入组人数
- 212
- 试验地点
- 3
- 主要终点
- necessary dose of propofol to obtain the induction of anesthesia (defined by a bispectral index of 50)
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 lidocaine)on anesthetic induction. Propofol plain or with lidocaine 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 lidocaine,
- •History of central neurological disorder or brain injury,
- •Patients receiving psychotropic drugs,
- •Patient with a pacemaker.
研究组 & 干预措施
Propofol Astrazeneca
Propofol with saline is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of saline.
干预措施: Propofol Astrazeneca plain (Drug)
Propofol Astrazeneca plus lidocaine
Propofol with lidocaine 1¨% is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of lidocaine.
干预措施: Propofol Astrazeneca plus lidocaine (Drug)
Propofol-lipuro B. Braun plain
Propofol with saline is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of saline.
干预措施: Propofol-lipuro B. Braun plain (Drug)
Propofol-lipuro B. Braun plus lidocaine
Propofol with lidocaine 1¨% is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of lidocaine.
干预措施: Propofol-lipuro B. Braun plus lidocaine (Drug)
Propofol Fresenius plain
Propofol with saline is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of saline.
干预措施: Propofol Fresenius plain (Drug)
Propofol Fresenius plus lidocaine
Propofol with lidocaine 1¨% is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of lidocaine.
干预措施: Propofol Fresenius plus lidocaine (Drug)
结局指标
主要结局
necessary dose of propofol to obtain the induction of anesthesia (defined by a bispectral index of 50)
时间窗: end of anesthetic induction
次要结局
- calculated concentrations of propofol at the end of the anesthetic induction(end of the anesthetic induction)
- measured plasma propofol concentrations at the end of anesthetic induction (in 20% of patients)(3 months after the end of patient's recruitment)
- pain at injection(during the PACU (post-anaesthesia care unit) stay)
- heart rate and arterial pressure modifications induced by anesthetic induction(end of anesthetic induction)
- patients satisfaction(during the PACU stay)
- necessary dose of propofol to obtain loss of consciousness(end of anesthetic induction)
- calculated concentrations of propofol at loss of consciousness(end of anesthetic induction)