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

Last updated: April 9, 2025
Sponsor: Centre Hospitalier Régional Metz-Thionville
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

EEG

Clinical Study ID

NCT06867289
2024-02-CHRMT
  • Ages 1-18
  • All Genders

Study 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

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 examinationappears 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

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 inthe 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 Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: EEG
Phase:
Study Start date:
April 08, 2025
Estimated Completion Date:
April 08, 2026

Study 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).

Connect with a study center

  • CHR Metz-Thionville Hopital Femme-Mère Enfant

    Metz, 57085
    France

    Active - Recruiting

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