Study of the Efficacy of Moderate Sedation With Intra-NAsal Dexmedetomidine Monitored by EEG MOnitoring
Recruiting
N/A
Interventional Study
Procedural Sedation and Analgesia
Pediatric ALL
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 1 – 18
- Sex
- Any
- Study type
- Interventional
- Purpose
- Diagnostic
- Participants needed
- 50 (estimated)
- Sponsor
- Centre Hospitalier Régional Metz-Thionville · Other
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About This Trial
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).
Trial Locations
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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, et…
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