Hypnosis Before the Induction of Anesthesia

Anesthesia Clinical Trial

— Hypnose2  

Official title:

Interest of Hypnosis Before the Induction of Anesthesia. Study in Women Submitted to One Day Gynecological Surgical Procedures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02249364
• Other study ID #: 2013/49
• Secondary ID: 2013-A01640-45
• Status: Completed
• Phase: N/A
• First received: September 23, 2014
• Last updated: October 28, 2016
• Start date: April 2014
• Est. completion date: December 2015

Study information

• Verified date: October 2016
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT02296827

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia

Intervention

Procedure:
• Control
Routine practice
• Hypnosis
Hypnosis session before induction of anesthesia

Drug:
• propofol
Closed-loop administration of propofol for anesthesia induction

Locations

Country	Name	City	State
France	Dept of Anesthesia, Hôpital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

References & Publications (1)

Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloë 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Target plasma concentration of propofol	Target plasma concentration of propofol corresponding to induction of anesthesia (bispectral index <60 for at least 30 seconds)	one hour	No
Secondary	Pain of insertion of peripheral vein catheter	Pain is assessed by two criteria: withdrawal of the arm perfused (no = 0; withdrawal = 1; violent withdrawal = 2),; spontaneous expression (no = 0; frown = 1; grin or verbal complaint = 2)	one hour	No
Secondary	Pain due to injection of propofol	Pain is assessed by two criteria: withdrawal of the arm perfused (no = 0; withdrawal = 1; violent withdrawal = 2),; spontaneous expression (no = 0; frown = 1; grin or verbal complaint = 2)	one hour	No
Secondary	Effect of hypnosis on bispectral index	Effect of hypnosis on bispectral index before the induction of anesthesia	one hour	No
Secondary	Time to loss of consciousness	Time between the beginning of injection of propofol and the loss of eyelash reflex	one hour	No
Secondary	Hemodynamic consequences of induction of anesthesia	Heart rate and blood pressure are measured just before induction of anesthesia and once it is realized.	one hour	No
Secondary	Administration of a cardio-vascular agent	Administration of ephedrine, atropine or of an hypotensive agent	one hour	No
Secondary	Manipulation of the airway	Necessity of a jaw thrust maneuver or of another manipulation of the airway during the induction of anesthesia	one hour	No
Secondary	Characteristics of the hypnotic procedure evaluated by the clinician in the group "hypnosis"	The hypnotic procedure is assessed by three criteria: receptivity of the patient (yes/no),; rapidity of focalization procedure (very fast, fast, medium, delayed, impossible to obtain),; quality of the hypnotic trance (very deep, deep, medium, superficial, not obtained).	one hour	No
Secondary	Characteristics of the hypnotic procedure evaluated by the patient in the group "hypnosis"	The hypnotic procedure is assessed by a question : "Did you visualize the memory we talked about before the session ? (yes, no )	six hours	No
Secondary	Characteristics of the preanesthetic management evaluated by the patient (all the patients)	The preanesthetic management is assessed by one criteria:"How do you rate the quality of the preanesthetic period (from the entrance in the operating room to the induction of the general anesthesia ?" (excellent, good, average, not good)	Six hours	No