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RECRUITING
NCT06867289
NA

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

Sponsor: Centre Hospitalier Régional Metz-Thionville

View on ClinicalTrials.gov

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).

Key Details

Gender

All

Age Range

1 Year - 18 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-04-08

Completion Date

2027-04-08

Last Updated

2026-03-12

Healthy Volunteers

No

Interventions

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.

Locations (1)

CHR Metz-Thionville Hopital Femme-Mère Enfant

Metz, France