Study of the Efficacy of Moderate Sedation With Intra-NAsal Dexmedetomidine Monitored by EEG MOnitoring (DINAMO)

Centre Hospitalier Régional Metz-Thionville

Status: Enrolling

Conditions: Procedural Sedation and Analgesia; Pediatric ALL

Treatments: Device: EEG

Study type: Interventional

Funder types: Other

Identifiers

NCT06867289

2024-02-CHRMT

Details and patient eligibility

About

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).

Full 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).

Enrollment: 50 estimated patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

50 participants in 1 patient group

EEG Monitoring and PSSS clinical score

Experimental group

Description:

All participants receive an EEG monitoring.

Treatment:

Device: EEG