Study of the Efficacy of Moderate Sedation With Intra-NAsal Dexmedetomidine Monitored by EEG MOni… (NCT06867289) | Clinical Trial Compass
RecruitingNot Applicable
Study of the Efficacy of Moderate Sedation With Intra-NAsal Dexmedetomidine Monitored by EEG MOnitoring
France50 participantsStarted 2025-04-08
Plain-language summary
This is a prospective, monocentric diagnostic study aiming to evaluate whether a sedation score obtained by a per-procedural electroencephalogram (EEG), the PSI score, could identify patients for whom a 2 μg/kg dose of DEX would not be sufficient for the successful performance of cerebral NMRI, and who could therefore benefit from a higher dosage of DEX (4 μg/kg).
Who can participate
Age range1 Year – 18 Years
SexALL
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Inclusion Criteria:
* Indication of DEX sedation for brain NMRI at the CHR de Metz-Thionville
* in a patient aged between 12 months and 5 years or
* for a patient aged between 5 and 18 whose cooperation during the examination appears compromised (previous failure, autism spectrum disorders, etc.).
* Membership of a social security scheme
* Free and informed consent obtained from the patient's legal guardian(s).
Exclusion Criteria:
* Weight \< 10 kg
* Patients with contraindications to the use of DEX
* Hypersensitivity to the active ingredient or to any of the excipients listed in the section on "Hypersensitivity".
* Advanced heart block (level 2 or 3), unless pacemaker implanted
* Uncontrolled hypotension
* Acute cerebrovascular pathologies
* Patients with nasal obstruction
* Parental refusal of DEX administration
* Minors under guardianship
* Minors under judicial sanction