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

NCT06867289 | Recruiting

• 1 other identifier: 2024-02-CHRMT
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Procedural Sedation and Analgesia; Pediatric ALL

Keywords

MRI; dexmedetomidine; EEG

Outcome Measures

Primary Outcomes (1)

• Prediction of complete NMRI success

  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.

  20 minutes after DEX administration

Secondary Outcomes (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.

  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.

  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.

  20 min after DEX administration

• Correlation between PSI and PSSS scores

  at 0, 10, 20 and 150 minutes after DEX administration

• Complications (Quality of recovery)

  at 150 minutes after DEX administration

Study Arms (1)

EEG Monitoring and PSSS clinical score

EXPERIMENTAL

All participants receive an EEG monitoring.

Device: EEG

Interventions

EEG DEVICE

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.

EEG Monitoring and PSSS clinical score

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify 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 may not qualify 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
• Patients with nasal obstruction
• Parental refusal of DEX administration
• Minors under guardianship
• Minors under judicial sanction

Sponsors & Collaborators

• Centre Hospitalier Régional Metz-Thionville: lead

Study Sites (1)

CHR Metz-Thionville Hopital Femme-Mère Enfant

Metz, 57085, France

RECRUITING

MeSH Terms

Conditions

Agnosia; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Electroencephalography

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Anne-Charlotte CULLIER, MD

  CHR Metz Thionville Hopital Femme Mère Enfant

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arpiné EL NAR, PhD

CONTACT

0033387557766; projet-recherche-clinique@chr-metz-thionville.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 28, 2025
• First Posted: March 10, 2025
• Study Start: April 8, 2025
• Primary Completion (Estimated): April 8, 2027
• Study Completion (Estimated): April 8, 2027
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

FR (1)