Preoperative Hypnosis Versus Premedication in Gynecological Surgery
NCT ID: NCT03327506
Last Updated: 2021-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
128 participants
INTERVENTIONAL
2018-11-27
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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hypnosis group
Intervention: hypnosis session the eve of the surgery
Alprazolam 0.5 mg
alprazolam 0,5 mg the eve and the morning of the surgery versus a preoperative hypnosis session
premedication
alprazolam 0,5 mg the eve and the morning of the surgery
Alprazolam 0.5 mg
alprazolam 0,5 mg the eve and the morning of the surgery versus a preoperative hypnosis session
Interventions
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Alprazolam 0.5 mg
alprazolam 0,5 mg the eve and the morning of the surgery versus a preoperative hypnosis session
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Central Hospital, Nancy, France
OTHER
Responsible Party
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Locations
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Florence Vial
Nancy, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2017-002112-13
Identifier Type: -
Identifier Source: org_study_id
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