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Recruiting NCT06867289

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

Trial Parameters

Condition Procedural Sedation and Analgesia
Sponsor Centre Hospitalier Régional Metz-Thionville
Study Type INTERVENTIONAL
Phase N/A
Enrollment 50
Sex ALL
Min Age 1 Year
Max Age 18 Years
Start Date 2025-04-08
Completion 2027-04-08
Interventions
EEG

Brief 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 Criteria

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

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