Study of the Efficacy of Moderate Sedation With Intra-NAsal Dexmedetomidine Monitored by EEG MOnitoring

Recruiting now · Not applicable

Conditions studied: Procedural Sedation and Analgesia, Pediatric ALL

In brief

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).

Key facts

Study ID: NCT06867289
Run by: Centre Hospitalier Régional Metz-Thionville
People needed: 50
Starts: 2025-04-08
Expected to finish: 2027-04-08
Last updated by the study team: 2026-03-12

Who can join

Age: 1 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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).

You may not qualify if…

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

Where it is running

CHR Metz-Thionville Hopital Femme-Mère Enfant — Metz, France (enrolling)

Full record on ClinicalTrials.gov

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