Hypnosis and Closed-Loop Anesthesia System (LoopHypnosis)
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|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|
|Actual Primary Completion Date :||December 2013|
|Actual 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01648725
|Suresnes, France, 92151|
|Principal Investigator:||Barbara Szekely, MD||Hopital Foch|