Evaluating sedation effectiveness with dexmedetomidine in children undergoing brain MRI
Study of the Efficacy of Moderate Sedation With Intra-NAsal Dexmedetomidine Monitored by EEG MOnitoring
This study is testing if a nasal spray of dexmedetomidine can safely and effectively help children aged 12 months to 18 years relax during a brain MRI.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 1 Year to 18 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Régional Metz-Thionville Academic / other |
| Locations | 1 site (Metz) |
| Trial ID | NCT06867289 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the efficacy of moderate sedation using intra-nasal dexmedetomidine (DEX) in children undergoing brain MRI. It focuses on utilizing a sedation score derived from electroencephalogram (EEG) monitoring to determine whether a standard dose of DEX is sufficient or if a higher dose is necessary for successful sedation. The study targets children aged 12 months to 18 years, particularly those with conditions that may hinder cooperation during the procedure. By identifying the appropriate dosage of DEX, the study seeks to enhance the safety and effectiveness of procedural sedation in pediatric patients.
Who should consider this trial
Good fit: Ideal candidates include children aged 12 months to 18 years requiring sedation for brain MRI, especially those with compromised cooperation.
Not a fit: Patients under 10 kg, those with contraindications to DEX, or those with nasal obstruction may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the success rate of brain MRIs in children, reducing the need for general anesthesia.
How similar studies have performed: While there is existing research on dexmedetomidine for sedation, this specific approach using EEG monitoring for dosage determination is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Metz
- CHR Metz-Thionville Hopital Femme-Mère Enfant — Metz, France (Recruiting)
Study contacts
- Principal investigator: Anne-Charlotte CULLIER, MD — CHR Metz Thionville Hopital Femme Mère Enfant
- Study coordinator: Arpiné EL NAR, PhD
- Email: projet-recherche-clinique@chr-metz-thionville.fr
- Phone: 0033387557766
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.