Hypnosis and Closed-Loop Anesthesia System

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. A particular aspect of this study is that induction is provided by a closed-loop system which delivers propofol according to bispectral index.

Official Title
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Influence of Hypnosis on the Propofol Requirement to Induce General Anesthesia

Conditions
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Anesthesia

Intervention / Treatment
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* Procedure: Hypnosis
* Procedure: usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patients scheduled for a surgical procedure under general anesthesia Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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 |
| --- | --- |
| Experimental: Hypnosis<br>standard care plus hypnosis followed by closed-loop administration of propofol for anesthesia induction | Procedure: Hypnosis<br>* A short preanesthetic hypnosis before induction of anesthesia<br>|
| Active Comparator: Control<br>standard care without hypnosis followed by closed-loop administration of propofol for anesthesia induction | Procedure: usual care<br>* Standard care before induction of anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |
| --- | --- | --- |
| calculated target plasma concentration corresponding to induction of anesthesia (bispectral index <60 for at least 30 seconds) |  | one hour | 
| pain of injection | 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 = 2) | one hour | 
| Hemodynamic consequences of induction of anesthesia | Heart rate and blood pressure are measured just before induction of anesthesia and once it realized. | one hour | 
| characteristics of the hypnotic procedure | For speed: focus obtained in a very fast (1), fast (2), medium (3), delayed (4), impossible to obtain (5). For quality: very deep (1), deep (2), medium (3), superficial (4), not obtained (5) | one hour | 
| Patient assessment of the induction of anesthesia | 4-point scale. | one hour | 
| Time to loss of consciousness | loss of eyelash reflex | one hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypnosis, Anesthesia, Propofol, Closed-loop