Hypnosis Before the Induction of Anesthesia

Study Overview
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Brief Summary
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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.

Official Title
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Interest of Hypnosis Before the Induction of Anesthesia. Study in Women Submitted to One Day Gynecological Surgical Procedures

Conditions
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Anesthesia

Intervention / Treatment
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* Procedure: Control
* Procedure: Hypnosis
* Drug: propofol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult female patients scheduled for a one day gynecological surgical procedures under general anesthesia Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Standard care without hypnosis session followed by closed-loop administration of propofol for anesthesia induction | Procedure: Control<br>* Routine practice<br>Drug: propofol<br>* Closed-loop administration of propofol for anesthesia induction<br>|
| Experimental: Hypnosis<br>Hypnosis session followed by closed-loop administration of propofol for anesthesia induction | Procedure: Hypnosis<br>* Hypnosis session before induction of anesthesia<br>Drug: propofol<br>* Closed-loop administration of propofol for anesthesia induction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Administered dose of propofol | Administered dose of propofol required to obtain the induction of anesthesia (bispectral index <60 for at least 30 seconds) | one hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target plasma concentration of propofol | Target plasma concentration of propofol corresponding to induction of anesthesia (bispectral index <60 for at least 30 seconds) | one hour | 
| Pain of insertion of peripheral vein catheter | Pain is assessed by two criteria: withdrawal of the arm perfused (no = 0; withdrawal = 1; violent withdrawal = 2), spontaneous expression (no = 0; frown = 1; grin or verbal complaint = 2) | one hour | 
| Pain due to injection of propofol | Pain is assessed by two criteria: withdrawal of the arm perfused (no = 0; withdrawal = 1; violent withdrawal = 2), spontaneous expression (no = 0; frown = 1; grin or verbal complaint = 2) | one hour | 
| Effect of hypnosis on bispectral index | Effect of hypnosis on bispectral index before the induction of anesthesia | one hour | 
| Time to loss of consciousness | Time between the beginning of injection of propofol and the loss of eyelash reflex | one hour | 
| Hemodynamic consequences of induction of anesthesia | Heart rate and blood pressure are measured just before induction of anesthesia and once it is realized. | one hour | 
| Administration of a cardio-vascular agent | Administration of ephedrine, atropine or of an hypotensive agent | one hour | 
| Manipulation of the airway | Necessity of a jaw thrust maneuver or of another manipulation of the airway during the induction of anesthesia | one hour | 
| Characteristics of the hypnotic procedure evaluated by the clinician in the group hypnosis | The hypnotic procedure is assessed by three criteria: receptivity of the patient (yes/no), rapidity of focalization procedure (very fast, fast, medium, delayed, impossible to obtain), quality of the hypnotic trance (very deep, deep, medium, superficial, not obtained). | one hour | 
| Characteristics of the hypnotic procedure evaluated by the patient in the group hypnosis | The hypnotic procedure is assessed by a question : Did you visualize the memory we talked about before the session ? (yes, no ) | six hours | 
| Characteristics of the preanesthetic management evaluated by the patient (all the patients) | The preanesthetic management is assessed by one criteria:How do you rate the quality of the preanesthetic period (from the entrance in the operating room to the induction of the general anesthesia ? (excellent, good, average, not good) | Six hours |