Anesthesia Clinical Trial
— LoopHypnosisOfficial title:
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.
Status | Completed |
Enrollment | 97 |
Est. completion date | December 2013 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Hopital Foch | Suresnes |
Lead Sponsor | Collaborator |
---|---|
Hopital Foch |
France,
Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloë 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Administered dose of propofol required to obtain the induction of anesthesia (bispectral index <60 for at least 30 seconds) | one hour | No | |
Secondary | calculated target plasma concentration corresponding to induction of anesthesia (bispectral index <60 for at least 30 seconds) | one hour | No | |
Secondary | pain of injection | 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) |
one hour | No |
Secondary | Hemodynamic consequences of induction of anesthesia | Heart rate and blood pressure are measured just before induction of anesthesia and once it realized. | one hour | No |
Secondary | characteristics of the hypnotic procedure | 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) |
one hour | No |
Secondary | Patient assessment of the induction of anesthesia | 4-point scale. | one hour | No |
Secondary | Time to loss of consciousness | loss of eyelash reflex | one hour | No |
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