Clinical trial NCT02249364: Hypnosis Before the Induction of Anesthesia
Official title: Interest of Hypnosis Before the Induction of Anesthesia. Study in Women Submitted to One Day Gynecological Surgical Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2014-09-25
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Administered dose of propofol
timeFrame: one hour
Secondary outcomes:
measure: Target plasma concentration of propofol
timeFrame: one hour
measure: Pain of insertion of peripheral vein catheter
timeFrame: one hour
measure: Pain due to injection of propofol
timeFrame: one hour
measure: Effect of hypnosis on bispectral index
timeFrame: one hour
measure: Time to loss of consciousness
timeFrame: one hour
measure: Hemodynamic consequences of induction of anesthesia
timeFrame: one hour
measure: Administration of a cardio-vascular agent
timeFrame: one hour
measure: Manipulation of the airway
timeFrame: one hour
measure: Characteristics of the hypnotic procedure evaluated by the clinician in the group "hypnosis"
timeFrame: one hour
measure: Characteristics of the hypnotic procedure evaluated by the patient in the group "hypnosis"
timeFrame: six hours
measure: Characteristics of the preanesthetic management evaluated by the patient (all the patients)
timeFrame: Six hours
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Dept of Anesthesia, Hôpital Foch
Study officials:
affiliation: Hopital Foch
name: Marc Fischler
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.