Hypnose2: Hypnosis Before the Induction of Anesthesia

• Sponsor: Hopital Foch (Other)
• Overall Status: Completed
• CT.gov ID: NCT02249364
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Duration (Months): 20
• Patients Per Site Per Month: 4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia	Procedure: Control; Procedure: Hypnosis; Drug: propofol	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Interest of Hypnosis Before the Induction of Anesthesia. Study in Women Submitted to One Day Gynecological Surgical Procedures
• Study Start Date: Apr 1, 2014
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control Standard care without hypnosis session followed by closed-loop administration of propofol for anesthesia induction	Procedure: Control; Routine practice; Drug: propofol; Closed-loop administration of propofol for anesthesia induction
Experimental: Hypnosis Hypnosis session followed by closed-loop administration of propofol for anesthesia induction	Procedure: Hypnosis; Hypnosis session before induction of anesthesia; Drug: propofol; Closed-loop administration of propofol for anesthesia induction

Outcome Measures

Primary Outcome Measures

1. Administered dose of propofol [one hour]

   Administered dose of propofol required to obtain the induction of anesthesia (bispectral index <60 for at least 30 seconds)

Secondary Outcome Measures

1. Target plasma concentration of propofol [one hour]

   Target plasma concentration of propofol corresponding to induction of anesthesia (bispectral index <60 for at least 30 seconds)

2. Pain of insertion of peripheral vein catheter [one hour]

   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)

3. Pain due to injection of propofol [one hour]

   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)

4. Effect of hypnosis on bispectral index [one hour]

   Effect of hypnosis on bispectral index before the induction of anesthesia

5. Time to loss of consciousness [one hour]

   Time between the beginning of injection of propofol and the loss of eyelash reflex

6. Hemodynamic consequences of induction of anesthesia [one hour]

   Heart rate and blood pressure are measured just before induction of anesthesia and once it is realized.

7. Administration of a cardio-vascular agent [one hour]

   Administration of ephedrine, atropine or of an hypotensive agent

8. Manipulation of the airway [one hour]

   Necessity of a jaw thrust maneuver or of another manipulation of the airway during the induction of anesthesia

9. Characteristics of the hypnotic procedure evaluated by the clinician in the group "hypnosis" [one hour]

   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).

10. Characteristics of the hypnotic procedure evaluated by the patient in the group "hypnosis" [six hours]

    The hypnotic procedure is assessed by a question : "Did you visualize the memory we talked about before the session ? (yes, no )

11. Characteristics of the preanesthetic management evaluated by the patient (all the patients) [Six hours]

    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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dept of Anesthesia, Hôpital Foch	Suresnes		France	92150

Sponsors and Collaborators

• Hopital Foch

Investigators

• Study Chair: Marc Fischler, Hopital Foch

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Hopital Foch
• ClinicalTrials.gov Identifier: NCT02249364
• Other Study ID Numbers: 2013/49; 2013-A01640-45; NCT02296827
• First Posted: Sep 25, 2014
• Last Update Posted: Oct 31, 2016
• Last Verified: Oct 1, 2016

• Additional relevant MeSH terms: Propofol

Study Results

No Results Posted as of Oct 31, 2016