« Effect of sedative and anxiolytic sedation on children experience after general anesthesia » PEDIA_prem study.

Phase 1

Recruiting

• Conditions: General anesthesia and sedative and anxiolytic sedation; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]; Therapeutic area: Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04]

• Registration Number: CTIS2022-501124-23-00
• Lead Sponsor: niversity Hospital Of Montpellier

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-03
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Children older than 7 years old and younger than 18 years old, Subject to undergo surgery under general anesthesia, Subject able to complete a self-questionnaire, Subject requiring intervention under general anesthesia

Exclusion Criteria

Subject suffering from anxiety disorders, Subject who is not affiliated with or benefiting from a social security plan, Subject suffering from cognitive disorders, Subject suffering from chronic pain, Subject with ADD (Attention Deficit Disorder) with or without hyperactivity; with or without treatment, Subjects suffering from mental retardation, Subjects receiving psychotropic treatment, Subjects whose ability to complete a self-administered questionnaire may be impaired by the intervention, Subject with a contraindication to midazolam or to dexmedetomidine, Subjects requiring peri-operative alpha agonist, Subject who has already participated in the pediaPREM study, Subject who needs to undergo an emergency procedure, Subjects who need preoperative hypnosis, Subject who needs general anesthesia for diagnostic purposes (biopsy, etc...), Subjects who need a neurosurgical intervention or had a surgical intervention in the month preceding inclusion., Subject who will have an iterative surgical intervention within 15 days (removal of material, burns, etc.), Subjects who are scheduled for surgery as part of oncology management, Pregnant or breastfeeding woman, Subject whose parent has not signed a written informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified