Actively Recruiting
Study of the Efficacy of Moderate Sedation With Intra-NAsal Dexmedetomidine Monitored by EEG MOnitoring
Led by Centre Hospitalier Régional Metz-Thionville · Updated on 2026-03-12
50
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Study of the Efficacy of Moderate Sedation With Intra-NAsal Dexmedetomidine Monitored by EEG MOnitoring
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Indication for dexmedetomidine sedation for brain MRI at CHR de Metz-Thionville
- Patient aged between 12 months and 5 years, or aged 5 to 18 years with compromised cooperation during MRI (e.g., previous failure, autism spectrum disorders)
- Membership in a social security scheme
- Free and informed consent given by the patient's legal guardian(s)
You will not qualify if you...
- Weight less than 10 kilograms
- Contraindications to dexmedetomidine use, including:
- Hypersensitivity to dexmedetomidine or any excipients
- Advanced heart block (level 2 or 3) unless a pacemaker is implanted
- Uncontrolled low blood pressure
- Acute cerebrovascular diseases
- Nasal obstruction
- Parental refusal of dexmedetomidine administration
- Minors under guardianship
- Minors under judicial sanction
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
CHR Metz-Thionville Hopital Femme-Mère Enfant
Metz, France, 57085
Actively Recruiting
Research Team
A
Arpiné EL NAR, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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