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Tests treatment safety and results for Procedural Sedation and Analgesia
Official title Study of the Efficacy of Moderate Sedation With Intra-NAsal Dexmedetomidine Monitored by EEG MOnitoring
ClinicalTrials.gov ID: NCT06867289
What this study is testing
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 18
You may be able to join if
- 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).
You likely can't join if
- 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
See the full eligibility 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).
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Metz, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Metz, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.