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LoopHypnosis: Hypnosis and Closed-Loop Anesthesia System

Sponsor
Hopital Foch (Other)
Overall Status
Completed
CT.gov ID
NCT01648725
Collaborator
(none)
97
Enrollment
1
Location
2
Arms
17
Duration (Months)
5.7
Patients Per Site Per Month

Study Details

Study Description

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.

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Hypnosis
  • Procedure: usual care
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
97 participants
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
Study Start Date :
Jul 1, 2012
Actual Primary Completion Date :
Dec 1, 2013
Actual Study Completion Date :
Dec 1, 2013

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Administered dose of propofol required to obtain the induction of anesthesia (bispectral index <60 for at least 30 seconds) [one hour]

Secondary Outcome Measures

  1. calculated target plasma concentration corresponding to induction of anesthesia (bispectral index <60 for at least 30 seconds) [one hour]

  2. pain of injection [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)

  3. Hemodynamic consequences of induction of anesthesia [one hour]

    Heart rate and blood pressure are measured just before induction of anesthesia and once it realized.

  4. characteristics of the hypnotic procedure [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)

  5. Patient assessment of the induction of anesthesia [one hour]

    4-point scale.

  6. Time to loss of consciousness [one hour]

    loss of eyelash reflex

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Locations

Site City State Country Postal Code
1 Hopital Foch Suresnes France 92151

Sponsors and Collaborators

  • Hopital Foch

Investigators

  • Principal Investigator: Barbara Szekely, MD, Hopital Foch

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Hopital Foch
ClinicalTrials.gov Identifier:
NCT01648725
Other Study ID Numbers:
  • 2012/12
  • 2012-A00369-34
First Posted:
Jul 24, 2012
Last Update Posted:
Oct 31, 2016
Last Verified:
Oct 1, 2016
Keywords provided by Hopital Foch
Hypnosis
Anesthesia
Propofol
Closed-loop

Study Results

No Results Posted as of Oct 31, 2016