Clinical trial · Interventional
Study of the Efficacy of Moderate Sedation With Intra-NAsal Dexmedetomidine Monitored by EEG MOnitoring
NCT06867289CI-TRIAL-00105333DINAMOrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pediatric ALL | Childhood Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Procedural Sedation and Analgesia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EEG | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- EEG Monitoring and PSSS clinical score
- description
- All participants receive an EEG monitoring.
- interventionNames
- Device: EEG
Primary outcomes (1)
- measure
- Prediction of complete NMRI success
- timeFrame
- 20 minutes after DEX administration
- description
- To describe the predictive value (ROC curve) of the PSI score assessed 20 minutes after administration of 2 μg/kg of DEX intranasally, for complete success in performing brain NMRI in children under 5 years of age, or over 5 years of age with risk of failure. Successful NMRI is defined as: * Complete if all prescribed sequences can be interpreted without reservation, * Partial if some of the sequences cannot be interpreted or are subject to reservations by the radiologist, * Absent if the examination is cancelled or if all sequences are uninterpretable or subject to reservations. PSI score: evaluated on EEG, the score varies from 0 to 100.
Secondary outcomes (9)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.