Status:
UNKNOWN
Preoperative Hypnosis Versus Premedication in Gynecological Surgery
Lead Sponsor:
Central Hospital, Nancy, France
Conditions:
Gynecologic Disease
Anxiety Disease
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
The aim of this study is to evaluate the efficacy of an hypnosis session, performed on the eve of a laparoscopic gynecological surgery, on the level of immediate preoperative anxiety measured by State...
Eligibility Criteria
Inclusion
- Patient's age: over 18 years
- Patient care and follow-up at the regional maternity center of Nancy (CHRU of Nancy)
- Female patient for whom gynecological laparoscopic surgery is programmed and lasting longer than 1 hour (ovarian cyst, laparoscopy infertility, laparoscopic promontofixation, noncarcinogenic assisted laparoscopy hysterectomy, endometriosis, diagnostic laparoscopy, pyosalpinx, hydrosalpinx)
- Patient with Physical status score (ASA) score between 1 and 3
- With standardized anesthesia protocol
- Patient affiliated to a Social Security
- Patient has received complete information about the organization of the research and has signed her informed consent
Exclusion
- Pretreatment by benzodiazepines
- Known hypersensitivity to Alprazolam® (including undocumented)
- Prohibition conditions to Alprazolam®: Severe respiratory insufficiency, Sleep apnea syndrome, Myasthenia, Severe acute or chronic hepatic impairment
- Ongoing major depressive episode
- Chronic use (\> 1 month) of benzodiazepines or morphine or analgesics of level 2
- Participation in a therapeutic trial 6 months before inclusion in this trial
- Patient referred to in Articles L. 1121-5 to L. 1121-8 and L1122-2 of the Public Health Code
Key Trial Info
Start Date :
November 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT03327506
Start Date
November 27 2018
End Date
December 1 2021
Last Update
February 23 2021
Active Locations (1)
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1
Florence Vial
Nancy, France, 54000