Hypnosis and Closed-Loop Anesthesia System

Influence of Hypnosis on the Propofol Requirement to Induce General Anesthesia

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01648725

Acronym

LoopHypnosis

Enrollment

Registered

2012-07-24

Start date

2012-07-31

Completion date

2013-12-31

Last updated

2016-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Keywords

Hypnosis, Anesthesia, Propofol, Closed-loop

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.

Interventions

PROCEDUREHypnosis

A short preanesthetic hypnosis before induction of anesthesia

PROCEDUREusual care

Standard care before induction of anesthesia

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.
calculated target plasma concentration corresponding to induction of anesthesia (bispectral index <60 for at least 30 seconds)	one hour	—
Patient assessment of the induction of anesthesia	one hour	4-point scale.
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)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026