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

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

Recruiting
1-18 years
All
Phase N/A

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Overview

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).

Description

For some children, brain MRI is a particularly important examination for etiological assessment or for monitoring the progress of neurological diseases. It can sometimes be complicated to perform, due to the age and/or pathology of the child concerned. Impossibility, postponement or the need for a general anaesthetic are constraints that should be avoided as far as possible. Procedural sedation with dexmedetomidine (DEX) can be administered intra-nasally. This technique offers good results and safety of use. Nevertheless, the failure rate is 20% to 30%, and may depend on the dosage of DEX used (indicated doses vary from 2 to 4 μg/kg). This study aims 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 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

Study details
    Procedural Sedation and Analgesia
    Pediatric ALL

NCT06867289

Centre Hospitalier Régional Metz-Thionville

16 October 2025

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