Hypnosis and Closed-Loop Anesthesia System (LoopHypnosis)

This study has been completed.
Information provided by (Responsible Party):
Hopital Foch
ClinicalTrials.gov Identifier:
First received: July 20, 2012
Last updated: March 25, 2015
Last verified: March 2015

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
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

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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

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

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: March 25, 2015
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Hopital Foch:

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

ClinicalTrials.gov processed this record on May 25, 2016