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

Launched by CENTRE HOSPITALIER RÉGIONAL METZ-THIONVILLE · Mar 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a way to make children more comfortable during a specific medical imaging test called a brain MRI. Researchers want to see if a special scoring system, which looks at brain activity using a test called an electroencephalogram (EEG), can help determine if a lower dose of a sedative medication called dexmedetomidine (DEX) is enough for some children. If the score shows that a child may need more sedation to feel calm and relaxed during the MRI, the study will provide a higher dose of DEX.

To be part of this trial, children must be between 12 months and 18 years old and need DEX sedation for their MRI. The study is looking for children who may have trouble cooperating during the procedure, like those with autism or previous unsuccessful MRIs. Parents or guardians will be asked to give their permission for their child to participate. Throughout the trial, participants will receive careful monitoring to ensure their safety and comfort during the MRI process.

Gender

ALL

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