Influence of Hypnosis on the Propofol Requirement to Induce General Anesthesia

Hopital Foch1 site in 1 country97 target enrollmentJuly 2012

ConditionsAnesthesia

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Anesthesia
Sponsor: Hopital Foch
Enrollment: 97
Locations: 1
Primary Endpoint: Administered dose of propofol required to obtain the induction of anesthesia (bispectral index <60 for at least 30 seconds)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2012

End Date

December 2013

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hopital Foch

Responsible Party

Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Administered dose of propofol required to obtain the induction of anesthesia (bispectral index <60 for at least 30 seconds)

Time Frame: one hour

Secondary Outcomes

Patient assessment of the induction of anesthesia(one hour)
calculated target plasma concentration corresponding to induction of anesthesia (bispectral index <60 for at least 30 seconds)(one hour)
pain of injection(one hour)
Hemodynamic consequences of induction of anesthesia(one hour)
Time to loss of consciousness(one hour)
characteristics of the hypnotic procedure(one hour)