Anesthesia
Conditions
Brief summary
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. Two particular aspects of this study are * the inclusion of women undergoing one day gynecological surgical procedures * the use of a closed-loop system which delivers propofol according to bispectral index to provide induction of anesthesia.
Interventions
PROCEDUREControl
Routine practice
PROCEDUREHypnosis
Hypnosis session before induction of anesthesia
DRUGpropofol
Closed-loop administration of propofol for anesthesia induction
Sponsors
Hopital Foch
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult female patients scheduled for a one day gynecological surgical procedures under general anesthesia
Exclusion criteria
* pregnancy, breast feeding woman * allergy to propofol, soy or peanuts * history of central nervous system disease * psychiatric affection * hypovolemia, high cardiovascular risk * patients with a pace-maker
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Administered dose of propofol | one hour | Administered dose of propofol required to obtain the induction of anesthesia (bispectral index \<60 for at least 30 seconds) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain of insertion of peripheral vein catheter | 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 or verbal complaint = 2) |
| Pain due to injection of propofol | 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 or verbal complaint = 2) |
| Effect of hypnosis on bispectral index | one hour | Effect of hypnosis on bispectral index before the induction of anesthesia |
| Time to loss of consciousness | one hour | Time between the beginning of injection of propofol and the loss of eyelash reflex |
| Hemodynamic consequences of induction of anesthesia | one hour | Heart rate and blood pressure are measured just before induction of anesthesia and once it is realized. |
| Target plasma concentration of propofol | one hour | Target plasma concentration of propofol corresponding to induction of anesthesia (bispectral index \<60 for at least 30 seconds) |
| Manipulation of the airway | one hour | Necessity of a jaw thrust maneuver or of another manipulation of the airway during the induction of anesthesia |
| Characteristics of the hypnotic procedure evaluated by the clinician in the group hypnosis | one hour | The hypnotic procedure is assessed by three criteria: * receptivity of the patient (yes/no), * rapidity of focalization procedure (very fast, fast, medium, delayed, impossible to obtain), * quality of the hypnotic trance (very deep, deep, medium, superficial, not obtained). |
| Characteristics of the hypnotic procedure evaluated by the patient in the group hypnosis | six hours | The hypnotic procedure is assessed by a question : Did you visualize the memory we talked about before the session ? (yes, no ) |
| Characteristics of the preanesthetic management evaluated by the patient (all the patients) | Six hours | The preanesthetic management is assessed by one criteria:How do you rate the quality of the preanesthetic period (from the entrance in the operating room to the induction of the general anesthesia ? (excellent, good, average, not good) |
| Administration of a cardio-vascular agent | one hour | Administration of ephedrine, atropine or of an hypotensive agent |
Countries
France
Outcome results
None listed