Hypnosis and Closed-Loop Anesthesia System (LoopHypnosis)
|ClinicalTrials.gov Identifier: NCT01648725|
Recruitment Status : Completed
First Posted : July 24, 2012
Last Update Posted : October 31, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Anesthesia||Procedure: Hypnosis Procedure: usual care||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||97 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Influence of Hypnosis on the Propofol Requirement to Induce General Anesthesia|
|Study Start Date :||July 2012|
|Primary Completion Date :||December 2013|
|Study Completion Date :||December 2013|
standard care plus hypnosis followed by closed-loop administration of propofol for anesthesia induction
A short preanesthetic hypnosis before induction of anesthesia
Active Comparator: Control
standard care without hypnosis followed by closed-loop administration of propofol for anesthesia induction
Procedure: usual care
Standard care before induction of anesthesia
- Administered dose of propofol required to obtain the induction of anesthesia (bispectral index <60 for at least 30 seconds) [ Time Frame: one hour ]
- calculated target plasma concentration corresponding to induction of anesthesia (bispectral index <60 for at least 30 seconds) [ Time Frame: one hour ]
- 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)
- 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.
- 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)
- Patient assessment of the induction of anesthesia [ Time Frame: one hour ]4-point scale.
- Time to loss of consciousness [ Time Frame: one hour ]loss of eyelash reflex
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01648725
|Suresnes, France, 92151|
|Principal Investigator:||Barbara Szekely, MD||Hopital Foch|