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Completed

NCT Number: NCT01648725

Hypnosis and Closed-Loop Anesthesia System

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.

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Key information

Conditions

Anesthesia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hopital Foch

Suresnes, 92151, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypnosis

Procedure

A short preanesthetic hypnosis before induction of anesthesia

usual care

Procedure

Standard care before induction of anesthesia

Primary outcomes

  1. 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

  1. calculated target plasma concentration corresponding to induction of anesthesia (bispectral index <60 for at least 30 seconds)

    Time frame: one hour

  2. 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)

  3. 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.

  4. 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)

  5. Patient assessment of the induction of anesthesia

    Time frame: one hour

    4-point scale.

  6. Time to loss of consciousness

    Time frame: one hour

    loss of eyelash reflex

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Official study title

Influence of Hypnosis on the Propofol Requirement to Induce General Anesthesia

Acronym: LoopHypnosis

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 24, 2012
Registry last updated
Oct 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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