Hypnosis and Closed-Loop Anesthesia System (LoopHypnosis)

This study is currently recruiting participants.
Verified November 2013 by Hopital Foch
Sponsor:
Information provided by (Responsible Party):
Hopital Foch
ClinicalTrials.gov Identifier:
NCT01648725
First received: July 20, 2012
Last updated: November 9, 2013
Last verified: November 2013

July 20, 2012
November 9, 2013
July 2012
July 2014   (final data collection date for primary outcome measure)
Administered dose of propofol required to obtain the induction of anesthesia (bispectral index <60 for at least 30 seconds) [ Time Frame: one hour ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01648725 on ClinicalTrials.gov Archive Site
  • calculated target plasma concentration corresponding to induction of anesthesia (bispectral index <60 for at least 30 seconds) [ Time Frame: one hour ] [ Designated as safety issue: No ]
  • pain of injection [ Time Frame: one hour ] [ Designated as safety issue: No ]

    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 [ Time Frame: one hour ] [ Designated as safety issue: No ]
    Heart rate and blood pressure are measured just before induction of anesthesia and once it realized.
  • characteristics of the hypnotic procedure [ Time Frame: one hour ] [ Designated as safety issue: No ]
    • 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)
  • Patient assessment of the induction of anesthesia [ Time Frame: one hour ] [ Designated as safety issue: No ]
    4-point scale.
  • Time to loss of consciousness [ Time Frame: one hour ] [ Designated as safety issue: No ]
    loss of eyelash reflex
Same as current
Not Provided
Not Provided
 
Hypnosis and Closed-Loop Anesthesia System
Influence of Hypnosis on the Propofol Requirement to Induce General Anesthesia

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Anesthesia
  • Procedure: Hypnosis
    A short preanesthetic hypnosis before induction of anesthesia
  • Procedure: usual care
    Standard care before induction of anesthesia
  • Experimental: Hypnosis
    standard care plus hypnosis followed by closed-loop administration of propofol for anesthesia induction
    Intervention: Procedure: Hypnosis
  • Active Comparator: Control
    standard care without hypnosis followed by closed-loop administration of propofol for anesthesia induction
    Intervention: Procedure: usual care
Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloe PA, Trillat B, Barvais L, Fischler M. Titration of propofol for anesthetic induction and maintenance guided by the bispectral index: closed-loop versus manual control: a prospective, randomized, multicenter study. Anesthesiology. 2006 Apr;104(4):686-95.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
July 2014
July 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Marc Fischler, MD 46252442 ext 00331 m.fischler@hopital-foch.org
France
 
NCT01648725
2012/12
No
Hopital Foch
Hopital Foch
Not Provided
Principal Investigator: Barbara Szekely, MD Hopital Foch
Hopital Foch
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP