Hypnosis and Closed-Loop Anesthesia System

Phase 4

Completed

• Conditions: Anesthesia
• Interventions: Procedure: usual care; Procedure: Hypnosis

• Registration Number: NCT01648725
• Lead Sponsor: Hopital Foch

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-20
• Study First Submitted QC: 2012-07-20
• Study First Posted: 2012-07-24
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-28
• Last Update Posted: 2016-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

Inclusion Criteria

• adult patients scheduled for a surgical procedure under general anesthesia

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	usual care	standard care without hypnosis followed by closed-loop administration of propofol for anesthesia induction
Hypnosis	Hypnosis	standard care plus hypnosis followed by closed-loop administration of propofol for anesthesia induction

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Patient assessment of the induction of anesthesia	one hour	4-point scale.
calculated target plasma concentration corresponding to induction of anesthesia (bispectral index <60 for at least 30 seconds)	one hour
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)
Hemodynamic consequences of induction of anesthesia	one hour	Heart rate and blood pressure are measured just before induction of anesthesia and once it realized.
Time to loss of consciousness	one hour	loss of eyelash reflex
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)

Trial Locations

Locations (1)

Hopital Foch; 🇫🇷 Suresnes, France