Hypnosis Before the Induction of Anesthesia

NCT02249364 | Completed

• 2 other identifiers: 2013/492013-A01640-45
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Target plasma concentration of propofol

  one hour

• Pain of insertion of peripheral vein catheter

  one hour

• Pain due to injection of propofol

  one hour

• Effect of hypnosis on bispectral index

  one hour

• Time to loss of consciousness

  one hour

Study Arms (2)

Control

ACTIVE COMPARATOR

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

Procedure: Control; Drug: propofol

Hypnosis

EXPERIMENTAL

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

Procedure: Hypnosis; Drug: propofol

Interventions

Control PROCEDURE

Routine practice

Control

Hypnosis PROCEDURE

Hypnosis session before induction of anesthesia

Hypnosis

propofol DRUG

Closed-loop administration of propofol for anesthesia induction

Control; Hypnosis

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hopital Foch: lead

Study Sites (1)

Dept of Anesthesia, Hôpital Foch

Suresnes, 92150, France

Location

Related Publications (2)

• 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.

  PMID: 16571963 BACKGROUND

• 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.

  PMID: 29210845 DERIVED

MeSH Terms

Interventions

Hypnosis; Propofol

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Marc Fischler

  Hopital Foch

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2014
• First Posted: September 25, 2014
• Study Start: April 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: October 31, 2016

Record last verified: 2016-10

Locations

FR (1)