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Clinical Trials/NCT02249364
NCT02249364
Completed
Not Applicable

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

Hopital Foch1 site in 1 country80 target enrollmentApril 2014
ConditionsAnesthesia

Overview

Phase
Not Applicable
Intervention
Control
Conditions
Anesthesia
Sponsor
Hopital Foch
Enrollment
80
Locations
1
Primary Endpoint
Administered dose of propofol
Status
Completed
Last Updated
9 years ago

Overview

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.
Registry
clinicaltrials.gov
Start Date
April 2014
End Date
December 2015
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

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

Arms & Interventions

Control

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

Intervention: Control

Control

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

Intervention: propofol

Hypnosis

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

Intervention: Hypnosis

Hypnosis

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

Intervention: propofol

Outcomes

Primary Outcomes

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

  • Pain due to injection of propofol(one hour)
  • Pain of insertion of peripheral vein catheter(one hour)
  • Effect of hypnosis on bispectral index(one hour)
  • Time to loss of consciousness(one hour)
  • Hemodynamic consequences of induction of anesthesia(one hour)
  • Administration of a cardio-vascular agent(one hour)
  • Manipulation of the airway(one hour)
  • Characteristics of the hypnotic procedure evaluated by the clinician in the group "hypnosis"(one hour)
  • Characteristics of the hypnotic procedure evaluated by the patient in the group "hypnosis"(six hours)
  • Characteristics of the preanesthetic management evaluated by the patient (all the patients)(Six hours)
  • Target plasma concentration of propofol(one hour)

Study Sites (1)

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