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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-18
SponsorCentre Hospitalier Régional Metz-Thionville

About this trial

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).

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • EEG

Treatment groups

50 Participants
are divided into 1 treatment group