Interest of Hypnosis Before the Induction of Anesthesia. Study in Women Submitted to One Day Gynecological Surgical Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Hopital Foch
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Administered dose of propofol
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.
Two particular aspects of this study are
- the inclusion of women undergoing one day gynecological surgical procedures
- the use of a closed-loop system which delivers propofol according to bispectral index to provide induction of anesthesia.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult female patients scheduled for a one day gynecological surgical procedures under general anesthesia
排除标准
- •pregnancy, breast feeding woman
- •allergy to propofol, soy or peanuts
- •history of central nervous system disease
- •psychiatric affection
- •hypovolemia, high cardiovascular risk
- •patients with a pace-maker
研究组 & 干预措施
Control
Standard care without hypnosis session followed by closed-loop administration of propofol for anesthesia induction
干预措施: Control (Procedure)
Control
Standard care without hypnosis session followed by closed-loop administration of propofol for anesthesia induction
干预措施: propofol (Drug)
Hypnosis
Hypnosis session followed by closed-loop administration of propofol for anesthesia induction
干预措施: Hypnosis (Procedure)
Hypnosis
Hypnosis session followed by closed-loop administration of propofol for anesthesia induction
干预措施: propofol (Drug)
结局指标
主要结局
Administered dose of propofol
时间窗: one hour
Administered dose of propofol required to obtain the induction of anesthesia (bispectral index \<60 for at least 30 seconds)
次要结局
- Pain due to injection of propofol(one hour)
- Pain of insertion of peripheral vein catheter(one hour)
- Effect of hypnosis on bispectral index(one hour)
- Time to loss of consciousness(one hour)
- Hemodynamic consequences of induction of anesthesia(one hour)
- Administration of a cardio-vascular agent(one hour)
- Manipulation of the airway(one hour)
- Characteristics of the hypnotic procedure evaluated by the clinician in the group "hypnosis"(one hour)
- Characteristics of the hypnotic procedure evaluated by the patient in the group "hypnosis"(six hours)
- Characteristics of the preanesthetic management evaluated by the patient (all the patients)(Six hours)
- Target plasma concentration of propofol(one hour)