RecruitingNot ApplicableNCT06867289

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

Sponsor

Centre Hospitalier Régional Metz-Thionville

Enrollment

50 participants

Start Date

Apr 8, 2025

Study Type

INTERVENTIONAL

Conditions

Pediatric ALL Procedural Sedation and Analgesia

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

Min Age: 1 YearMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether using EEG brain monitoring during sedation with a drug called dexmedetomidine (given through the nose) helps improve the quality and safety of sedation for young children and anxious older children who need brain MRI scans. **You may be eligible if...** - You are between 12 months and 5 years old and need a brain MRI with sedation, OR - You are between 5 and 18 years old and have difficulty cooperating with the MRI (e.g., due to autism spectrum disorder or previous failed attempts) - You are covered by a social security scheme - A parent or legal guardian has provided consent **You may NOT be eligible if...** - You have a known allergy to dexmedetomidine - You have serious heart problems or very low blood pressure - Your parent or guardian refuses consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEEEG

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.