Hypnosis and Closed-Loop Anesthesia System (LoopHypnosis)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Hopital Foch
Sponsor:
Information provided by (Responsible Party):
Hopital Foch
ClinicalTrials.gov Identifier:
NCT01648725
First received: July 20, 2012
Last updated: November 9, 2013
Last verified: November 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • calculated target plasma concentration corresponding to induction of anesthesia (bispectral index <60 for at least 30 seconds) [ Time Frame: one hour ] [ Designated as safety issue: No ]
  • pain of injection [ Time Frame: one hour ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: No ]
    4-point scale.

  • Time to loss of consciousness [ Time Frame: one hour ] [ Designated as safety issue: No ]
    loss of eyelash reflex


Estimated Enrollment: 100
Study Start Date: July 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01648725

Contacts
Contact: Marc Fischler, MD 46252442 ext 00331 m.fischler@hopital-foch.org

Locations
France
Hopital Foch Recruiting
Suresnes, France, 92151
Contact: Barbara Szekely, MD    46252442 ext 00331    b.szekely@hopital-foch.org   
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
Study First Received: July 20, 2012
Last Updated: November 9, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

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

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

ClinicalTrials.gov processed this record on July 22, 2014