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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03327506
Other study ID # 2017-002112-13
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date November 27, 2018
Est. completion date December 2021

Study information

Verified date February 2021
Source Central Hospital, Nancy, France
Contact florence vial
Phone 0033610405237
Email f.vial@chu-nancy.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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-Trait Anxiety Index (STAI-Y) self-administered questionnaire compared to premedication by alprazolam®.


Recruitment information / eligibility

Status Recruiting
Enrollment 128
Est. completion date December 2021
Est. primary completion date December 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Criteria: - Pretreatment by benzodiazepines - Known hypersensitivity to AlprazolamĀ® (including undocumented) - Prohibition conditions to AlprazolamĀ®: 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Alprazolam 0.5 mg
alprazolam 0,5 mg the eve and the morning of the surgery versus a preoperative hypnosis session

Locations

Country Name City State
France Florence Vial Nancy

Sponsors (1)

Lead Sponsor Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Preoperative Anxiety score evaluated by STAI-Y evaluated by STAI-Y self-administered questionary before surgery (day 2_before)
Secondary Anxiety score evaluated by analogue visual scale evaluated by analogue visual scale (EVA 0 to 10) at inclusion visit (day 1), before surgery (day 2_before), after surgery (day 2_after), 24 h after the surgery (day 3)
Secondary sleep quality evaluated by EVA scale evaluated by EVA scale (0 to 10) day 2_before and the day 3
Secondary patient satisfaction score evaluated by EVA scale evaluated by EVA scale (0 to 10) day 3
Secondary analysis of salivary amylase salivary amylase day 1 and day2_before
Secondary postoperative fatigue evaluated by EVA scale evaluated by EVA scale (0 to 10) day 3
Secondary Intraoperative morphine and hypnotics drugs Consumption Consumption day 3
Secondary Incidence of nausea and vomiting Incidence day 3
Secondary Score of pain measured by EVA scale measured by EVA (0 to 10) day 2_after, day 2_recovery room (at the end of recovery room) and Day 3
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