NCT06867289 Study of the Efficacy of Moderate Sedation With Intra-NAsal Dexmedetomidine Monitored by EEG MOnitoring
| NCT ID | NCT06867289 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Régional Metz-Thionville |
| Condition | Procedural Sedation and Analgesia |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-04-08 |
| Primary Completion | 2027-04-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2025-04-08 with a primary completion date of 2027-04-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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, etc.). * Membership of a social security scheme * Free and informed consent obtained from the patient's legal guardian(s). Exclusion Criteria: * Weight \< 10 kg * Patients with contraindications to the use of DEX * Hypersensitivity to the active ingredient or to any of the excipients listed in the section on "Hypersensitivity". * Advanced heart block (level 2 or 3), unless pacemaker implanted * Uncontrolled hypotension * Acute cerebrovascular pathologies * Patients with nasal obstruction * Parental refusal of DEX administration * Minors under guardianship * Minors under judicial sanction
Contact & Investigator
Anne-Charlotte CULLIER, MD
PRINCIPAL INVESTIGATOR
CHR Metz Thionville Hopital Femme Mère Enfant
Frequently Asked Questions
Who can join the NCT06867289 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 18 Years, studying Procedural Sedation and Analgesia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06867289 currently recruiting?
Yes, NCT06867289 is actively recruiting participants. Contact the research team at projet-recherche-clinique@chr-metz-thionville.fr for enrollment information.
Where is the NCT06867289 trial being conducted?
This trial is being conducted at Metz, France.
Who is sponsoring the NCT06867289 clinical trial?
NCT06867289 is sponsored by Centre Hospitalier Régional Metz-Thionville. The principal investigator is Anne-Charlotte CULLIER, MD at CHR Metz Thionville Hopital Femme Mère Enfant. The trial plans to enroll 50 participants.