Hypnosis and Closed-Loop Anesthesia System

NCT ID: NCT01648725

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

PHASE4

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-12-31

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.

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

Detailed Description

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Conditions

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Anesthesia

Keywords

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Hypnosis Anesthesia Propofol Closed-loop

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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Hypnosis

standard care plus hypnosis followed by closed-loop administration of propofol for anesthesia induction

Group Type EXPERIMENTAL

Hypnosis

Intervention Type PROCEDURE

A short preanesthetic hypnosis before induction of anesthesia

Control

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

Group Type ACTIVE_COMPARATOR

usual care

Intervention Type PROCEDURE

Standard care before induction of anesthesia

Interventions

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Hypnosis

A short preanesthetic hypnosis before induction of anesthesia

Intervention Type PROCEDURE

usual care

Standard care before induction of anesthesia

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

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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Barbara Szekely, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Foch

Locations

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Hopital 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)

Other Identifiers

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2012-A00369-34

Identifier Type: OTHER

Identifier Source: secondary_id

2012/12

Identifier Type: -

Identifier Source: org_study_id