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Completed

NCT Number: NCT02249364

Hypnosis Before the Induction of Anesthesia

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.

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Key information

Conditions

Anesthesia

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dept of Anesthesia, Hôpital Foch

Suresnes, 92150, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control

Procedure

Routine practice

Hypnosis

Procedure

Hypnosis session before induction of anesthesia

Propofol

Drug

Closed-loop administration of propofol for anesthesia induction

Primary outcomes

  1. Administered dose of propofol

    Time frame: one hour

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

Secondary outcomes

  1. Target plasma concentration of propofol

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: one hour

    Effect of hypnosis on bispectral index before the induction of anesthesia

  5. Time to loss of consciousness

    Time frame: one hour

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

  6. Hemodynamic consequences of induction of anesthesia

    Time frame: 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

    Time frame: one hour

    Administration of ephedrine, atropine or of an hypotensive agent

  8. Manipulation of the airway

    Time frame: 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"

    Time frame: 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"

    Time frame: 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)

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Official study title

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

Acronym: Hypnose2

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 25, 2014
Registry last updated
Oct 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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