Study of the Efficacy of Moderate Sedation With Intra-NAsal Dexmedetomidine Monitored by EEG MOnitoring
Centre Hospitalier Régional Metz-Thionville
50 participants
Apr 8, 2025
INTERVENTIONAL
Conditions
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).
Eligibility
Inclusion Criteria5
- 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 Criteria10
- 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
Interventions
EEG monitoring will be performed in addition to the usual practice, before DEX administration and for 20 minutes before NMRI, to enable calculation of the PSI sedation score (at 0, 10, 20 minutes). Sedation will also be assessed by the PSSS clinical score at 0, 10, 20 minutes after DEX administration, as well as at 150 minutes after DEX.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06867289