Hypnosis and Closed-Loop Anesthesia System (LoopHypnosis)

October 28, 2016 updated by: Hopital Foch

Influence of Hypnosis on the Propofol Requirement to Induce General Anesthesia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

97

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Suresnes, France, 92151
        • Hôpital Foch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
calculated target plasma concentration corresponding to induction of anesthesia (bispectral index <60 for at least 30 seconds)
Time Frame: one hour
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)
one hour
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.
one hour
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)
one hour
Patient assessment of the induction of anesthesia
Time Frame: one hour
4-point scale.
one hour
Time to loss of consciousness
Time Frame: one hour
loss of eyelash reflex
one hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital Foch

Investigators

  • Principal Investigator: Barbara Szekely, MD, Hôpital Foch

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

July 20, 2012

First Submitted That Met QC Criteria

July 20, 2012

First Posted (Estimate)

July 24, 2012

Study Record Updates

Last Update Posted (Estimate)

October 31, 2016

Last Update Submitted That Met QC Criteria

October 28, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2012/12
  • 2012-A00369-34 (Other Identifier: AFSSAPS)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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