Study of the Efficacy of Moderate Sedation With Intra-NAsal Dexmedetomidine Monitored by EEG MOnitoring
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: EEG.
- Who it may be relevant to
- Registry conditions: Procedural Sedation and Analgesia, Pediatric ALL. Basic parameters: 1 year — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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).
Detailed description
For some children, brain MRI is a particularly important examination for etiological assessment or for monitoring the progress of neurological diseases. It can sometimes be complicated to perform, due to the age and/or pathology of the child concerned. Impossibility, postponement or the need for a general anaesthetic are constraints that should be avoided as far as possible. Procedural sedation with dexmedetomidine (DEX) can be administered intra-nasally. This technique offers good results and safety of use. Nevertheless, the failure rate is 20% to 30%, and may depend on the dosage of DEX used (indicated doses vary from 2 to 4 μg/kg). This study aims 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).
Interventions
- Device EEG
EEG monitoring will be performed in addition to the usual practice, before DEX administration and for 20 minutes before NMRI, to enable calculation of the PSI sedation score (at 0, 10, 20 minutes). Sedation will also be assessed by the PSSS clinical score at 0, 10, 20 minutes after DEX administration, as well as at 150 minutes after DEX.
Primary outcome measures
- Prediction of complete NMRI success [Time frame: 20 minutes after DEX administration]
Secondary outcome measures (9)
- Complete or partial success in performing brain NMRI in children under 5 years of age, or over 5 years of age with risk of failure. [Time frame: 20 minutes after DEX administration]
- Predictive value (ROC curve) of the PSI score for successful completion of brain MRI in children under 5 years of age, or over 5 years of age with risk of failure. [Time frame: 20 min after DEX administration]
- Predictive value (ROC curve) of the PSSS score for successful completion of brain MRI in children under 5 years of age, or over 5 years of age with risk of failure. [Time frame: 20 min after DEX administration]
- Correlation between PSI and PSSS scores [Time frame: at 0, 10, 20 and 150 minutes after DEX administration]
- Complications (Quality of recovery) [Time frame: at 150 minutes after DEX administration]
- Complications (Blood Pressure) [Time frame: at 0, 10, 20 and 150 minutes after DEX administration]
- Complications (Heart Rate) [Time frame: at 0, 10, 20 and 150 minutes after DEX administration]
- Complications (Oxygen Saturation) [Time frame: at 0, 10, 20 and 150 minutes after DEX administration]
- Complications (allergic reactions) [Time frame: at 0, 10, 20 and 150 minutes after DEX administration]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 1 center
- CHR Metz-Thionville Hopital Femme-Mère Enfant — Metz
Identifiers
NCT: NCT06867289 · 2024-02-CHRMT