Hypnosis Before the Induction of Anesthesia

Not Applicable

Completed

• Conditions: Anesthesia
• Interventions: Procedure: Control; Procedure: Hypnosis; Drug: propofol

• Registration Number: NCT02249364
• Lead Sponsor: Hopital Foch

Brief Summary

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-09-23
• Study First Submitted QC: 2014-09-24
• Study First Posted: 2014-09-25
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-28
• Last Update Posted: 2016-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

• Adult female patients scheduled for a one day gynecological surgical procedures under general anesthesia

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	Standard care without hypnosis session followed by closed-loop administration of propofol for anesthesia induction
Control	propofol	Standard care without hypnosis session followed by closed-loop administration of propofol for anesthesia induction
Hypnosis	Hypnosis	Hypnosis session followed by closed-loop administration of propofol for anesthesia induction
Hypnosis	propofol	Hypnosis session followed by closed-loop administration of propofol for anesthesia induction

Primary Outcome Measures

Name	Time	Method
Administered dose of propofol	one hour	Administered dose of propofol required to obtain the induction of anesthesia (bispectral index \<60 for at least 30 seconds)

Secondary Outcome Measures

Name	Time	Method
Pain of insertion of peripheral vein catheter	one hour	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)
Pain due to injection of propofol	one hour	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)
Effect of hypnosis on bispectral index	one hour	Effect of hypnosis on bispectral index before the induction of anesthesia
Time to loss of consciousness	one hour	Time between the beginning of injection of propofol and the loss of eyelash reflex
Hemodynamic consequences of induction of anesthesia	one hour	Heart rate and blood pressure are measured just before induction of anesthesia and once it is realized.
Administration of a cardio-vascular agent	one hour	Administration of ephedrine, atropine or of an hypotensive agent
Manipulation of the airway	one hour	Necessity of a jaw thrust maneuver or of another manipulation of the airway during the induction of anesthesia
Characteristics of the hypnotic procedure evaluated by the clinician in the group "hypnosis"	one hour	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).
Characteristics of the hypnotic procedure evaluated by the patient in the group "hypnosis"	six hours	The hypnotic procedure is assessed by a question : "Did you visualize the memory we talked about before the session ? (yes, no )
Characteristics of the preanesthetic management evaluated by the patient (all the patients)	Six hours	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)
Target plasma concentration of propofol	one hour	Target plasma concentration of propofol corresponding to induction of anesthesia (bispectral index \<60 for at least 30 seconds)

Trial Locations

Locations (1)

Dept of Anesthesia, Hôpital Foch; 🇫🇷 Suresnes, France