Clinical trial NCT06867289: Study of the Efficacy of Moderate Sedation With Intra-NAsal Dexmedetomidine Monitored by EEG MOnitoring
Official title: Study of the Efficacy of Moderate Sedation With Intra-NAsal Dexmedetomidine Monitored by EEG MOnitoring
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Procedural Sedation and Analgesia
Pediatric ALL
Keywords: MRI
dexmedetomidine
EEG
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2025-03-10
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A cohort of patients with an indication for DEX sedation for brain NMRI will be included. EEG monitoring will be performed in addition to usual practice, prior to DEX administration and for 20 minutes prior to 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 purpose: DIAGNOSTIC

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).

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).

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

Primary outcomes:
measure: Prediction of complete NMRI success
timeFrame: 20 minutes after DEX administration
Secondary outcomes:
measure: 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.
timeFrame: 20 minutes after DEX administration
measure: 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.
timeFrame: 20 min after DEX administration
measure: 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.
timeFrame: 20 min after DEX administration
measure: Correlation between PSI and PSSS scores
timeFrame: at 0, 10, 20 and 150 minutes after DEX administration
measure: Complications (Quality of recovery)
timeFrame: at 150 minutes after DEX administration
measure: Complications (Blood Pressure)
timeFrame: at 0, 10, 20 and 150 minutes after DEX administration
measure: Complications (Heart Rate)
timeFrame: at 0, 10, 20 and 150 minutes after DEX administration
measure: Complications (Oxygen Saturation)
timeFrame: at 0, 10, 20 and 150 minutes after DEX administration
measure: Complications (allergic reactions)
timeFrame: at 0, 10, 20 and 150 minutes after DEX administration
Other outcomes:
Locations:
city: Metz
country: France
facility: CHR Metz-Thionville Hopital Femme-Mère Enfant
Study officials:
affiliation: CHR Metz Thionville Hopital Femme Mère Enfant
name: Anne-Charlotte CULLIER, MD
role: PRINCIPAL_INVESTIGATOR
References: