Hypnosis Before the Induction of Anesthesia (Hypnose2)

Hopital Foch

Status: Completed

Conditions: Anesthesia

Treatments: Drug: propofol; Procedure: Control; Procedure: Hypnosis

Study type: Interventional

Funder types: Other

Identifiers

NCT02249364

2013/49

2013-A01640-45 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Control

Active Comparator group

Description:

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

Treatment:

Procedure: Control

Drug: propofol

Hypnosis

Experimental group

Description:

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

Treatment:

Procedure: Hypnosis

Drug: propofol