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Hypnosis Before the Induction of Anesthesia

NCT ID: NCT02249364

Last Updated: 2016-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-12-31

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.

Detailed Description

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Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

Standard care without hypnosis session followed by closed-loop administration of propofol for anesthesia induction

Group Type ACTIVE_COMPARATOR

Control

Intervention Type PROCEDURE

Routine practice

propofol

Intervention Type DRUG

Closed-loop administration of propofol for anesthesia induction

Hypnosis

Hypnosis session followed by closed-loop administration of propofol for anesthesia induction

Group Type EXPERIMENTAL

Hypnosis

Intervention Type PROCEDURE

Hypnosis session before induction of anesthesia

propofol

Intervention Type DRUG

Closed-loop administration of propofol for anesthesia induction

Interventions

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Control

Routine practice

Intervention Type PROCEDURE

Hypnosis

Hypnosis session before induction of anesthesia

Intervention Type PROCEDURE

propofol

Closed-loop administration of propofol for anesthesia induction

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hopital Foch

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marc Fischler

Role: STUDY_CHAIR

Hopital Foch

Locations

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Dept of Anesthesia, Hôpital Foch

Suresnes, , France

Site Status

Countries

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France

References

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Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloe PA, Trillat B, Barvais L, Fischler M. Titration of propofol for anesthetic induction and maintenance guided by the bispectral index: closed-loop versus manual control: a prospective, randomized, multicenter study. Anesthesiology. 2006 Apr;104(4):686-95. doi: 10.1097/00000542-200604000-00012.

Reference Type BACKGROUND
PMID: 16571963 (View on PubMed)

Bataille A, Guirimand A, Szekely B, Michel-Cherqui M, Dumans V, Liu N, Chazot T, Fischler M, Le Guen M. Does a hypnosis session reduce the required propofol dose during closed-loop anaesthesia induction?: A randomised controlled trial. Eur J Anaesthesiol. 2018 Sep;35(9):675-681. doi: 10.1097/EJA.0000000000000751.

Reference Type DERIVED
PMID: 29210845 (View on PubMed)

Other Identifiers

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2013-A01640-45

Identifier Type: OTHER

Identifier Source: secondary_id

2013/49

Identifier Type: -

Identifier Source: org_study_id

NCT02296827

Identifier Type: -

Identifier Source: nct_alias