Hypnosis and Closed-Loop Anesthesia System (LoopHypnosis)

Hopital Foch

Status and phase: Completed; Phase 4

Conditions: Anesthesia

Treatments: Procedure: usual care; Procedure: Hypnosis

Study type: Interventional

Funder types: Other

Identifiers

NCT01648725

2012-A00369-34 (Other Identifier)

2012/12

Details and patient eligibility

About

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.

Enrollment: 97 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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97 participants in 2 patient groups

Hypnosis

Experimental group

Description:

standard care plus hypnosis followed by closed-loop administration of propofol for anesthesia induction

Treatment:

Procedure: Hypnosis

Control

Active Comparator group

Description:

standard care without hypnosis followed by closed-loop administration of propofol for anesthesia induction

Treatment:

Procedure: usual care