NCT06867289

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Centre Hospitalier Régional Metz-Thionville · Academic / Other
• Sex: All
• Age: 1 Year – 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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).

Conditions

• Procedural Sedation and Analgesia
• Pediatric ALL

Interventions

Type	Name	Description
DEVICE	EEG	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.

Timeline

• Start date: 2025-04-08
• Primary completion: 2027-04-08
• Completion: 2027-04-08
• First posted: 2025-03-10
• Last updated: 2026-03-12

Locations

1 site across 1 country: France