NCT01648725已完成4 期
Influence of Hypnosis on the Propofol Requirement to Induce General Anesthesia
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Hopital Foch
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- Administered dose of propofol required to obtain the induction of anesthesia (bispectral index <60 for at least 30 seconds)
研究概览
简要总结
Hypnosis may reduce patient anxiety. The main goal of this study is to determine in what extent, hypnosis decreases propofol requirement to induce induction of general anesthesia.
A particular aspect of this study is that induction is provided by a closed-loop system which delivers propofol according to bispectral index.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients scheduled for a surgical procedure under general anesthesia
排除标准
- •pregnancy, breast feeding woman
- •allergy to propofol, soy or peanuts
- •history of central nervous system disease
- •patient receiving a psychotropic treatment
- •patient treated by a psychiatrist or a psychologist
- •hypovolemia, high cardiovascular risk
- •patients with a pace-maker
研究组 & 干预措施
Hypnosis
Experimental
standard care plus hypnosis followed by closed-loop administration of propofol for anesthesia induction
干预措施: Hypnosis (Procedure)
Control
Active Comparator
standard care without hypnosis followed by closed-loop administration of propofol for anesthesia induction
干预措施: usual care (Procedure)
结局指标
主要结局
Administered dose of propofol required to obtain the induction of anesthesia (bispectral index <60 for at least 30 seconds)
时间窗: one hour
次要结局
- Patient assessment of the induction of anesthesia(one hour)
- calculated target plasma concentration corresponding to induction of anesthesia (bispectral index <60 for at least 30 seconds)(one hour)
- pain of injection(one hour)
- Hemodynamic consequences of induction of anesthesia(one hour)
- Time to loss of consciousness(one hour)
- characteristics of the hypnotic procedure(one hour)
研究者
研究点 (1)
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