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Hypnosis and Closed-Loop Anesthesia System (LoopHypnosis)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01648725
First Posted: July 24, 2012
Last Update Posted: October 31, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hopital Foch
  Purpose

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.

A particular aspect of this study is that induction is provided by a closed-loop system which delivers propofol according to bispectral index.


Condition Intervention Phase
Anesthesia Procedure: Hypnosis Procedure: usual care Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Influence of Hypnosis on the Propofol Requirement to Induce General Anesthesia

Resource links provided by NLM:


Further study details as provided by Hopital Foch:

Primary Outcome Measures:
  • Administered dose of propofol required to obtain the induction of anesthesia (bispectral index <60 for at least 30 seconds) [ Time Frame: one hour ]

Secondary Outcome Measures:
  • calculated target plasma concentration corresponding to induction of anesthesia (bispectral index <60 for at least 30 seconds) [ Time Frame: one hour ]
  • pain of injection [ 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 = 2)

  • 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 realized.

  • characteristics of the hypnotic procedure [ Time Frame: one hour ]
    • For speed: focus obtained in a very fast (1), fast (2), medium (3), delayed (4), impossible to obtain (5).
    • For quality: very deep (1), deep (2), medium (3), superficial (4), not obtained (5)

  • Patient assessment of the induction of anesthesia [ Time Frame: one hour ]
    4-point scale.

  • Time to loss of consciousness [ Time Frame: one hour ]
    loss of eyelash reflex


Enrollment: 97
Study Start Date: July 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hypnosis
standard care plus hypnosis followed by closed-loop administration of propofol for anesthesia induction
Procedure: Hypnosis
A short preanesthetic hypnosis before induction of anesthesia
Active Comparator: Control
standard care without hypnosis followed by closed-loop administration of propofol for anesthesia induction
Procedure: usual care
Standard care before induction of anesthesia

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients scheduled for a surgical procedure under general anesthesia

Exclusion Criteria:

  • pregnancy, breast feeding woman
  • allergy to propofol, soy or peanuts
  • history of central nervous system disease
  • patient receiving a psychotropic treatment
  • patient treated by a psychiatrist or a psychologist
  • hypovolemia, high cardiovascular risk
  • patients with a pace-maker
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01648725


Locations
France
Hopital Foch
Suresnes, France, 92151
Sponsors and Collaborators
Hopital Foch
Investigators
Principal Investigator: Barbara Szekely, MD Hopital Foch
  More Information

Publications:
Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT01648725     History of Changes
Other Study ID Numbers: 2012/12
2012-A00369-34 ( Other Identifier: AFSSAPS )
First Submitted: July 20, 2012
First Posted: July 24, 2012
Last Update Posted: October 31, 2016
Last Verified: October 2016

Keywords provided by Hopital Foch:
Hypnosis
Anesthesia
Propofol
Closed-loop

Additional relevant MeSH terms:
Anesthetics
Propofol
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General