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

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).

Study Overview

• Status: Recruiting
• Conditions: Pediatric ALL; Procedural Sedation and Analgesia
• Intervention / Treatment: Device: EEG

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).

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Arpiné EL NAR, PhD; Phone Number: 0033387557766; Email: projet-recherche-clinique@chr-metz-thionville.fr

Study Locations

• France
  • Metz, France, 57085
    • Recruiting
    • CHR Metz-Thionville Hopital Femme-Mère Enfant
    • Contact: Arpiné EL NAR, PhD; Phone Number: 0033387557766; Email: projet-recherche-clinique@chr-metz-thionville.fr
    • Principal Investigator: Anne-Charlotte CULLIER, MD
    • Sub-Investigator: Claire BILBAULT, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EEG Monitoring and PSSS clinical score; All participants receive an EEG monitoring.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Area under the ROC curve for prediction of complete or partial success of NMRI according to PSI score. 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.	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.	Area under the ROC curve for prediction of complete success of NMRI according to PSI score by patient age under or over 5 years old 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 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.	Area under the ROC curve for prediction of complete or partial success of NMRI according to PSSS score at 20 minutes 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. PSSS score: ranges from 0 (deepest sedation) to 5 (shallowest sedation) depending on the observation of clinical signs in children	20 min after DEX administration
Correlation between PSI and PSSS scores	Describe the correlation between PSI score and PSSS score PSI scores at 0, 10, 20 and 150 minutes after DEX administration and PSSS scores at 0, 10, 20 and 150 minutes after DEX administration	at 0, 10, 20 and 150 minutes after DEX administration
Complications (Quality of recovery)	PSSS score: ranges from 0 (deepest sedation) to 5 (shallowest sedation) depending on the observation of clinical signs in children	at 150 minutes after DEX administration
Complications (Blood Pressure)	mmHg	at 0, 10, 20 and 150 minutes after DEX administration
Complications (Heart Rate)	bpm	at 0, 10, 20 and 150 minutes after DEX administration
Complications (Oxygen Saturation)	SaO2 (%)	at 0, 10, 20 and 150 minutes after DEX administration
Complications (allergic reactions)	number and types	at 0, 10, 20 and 150 minutes after DEX administration

Collaborators and Investigators

• Sponsor: Centre Hospitalier Régional Metz-Thionville
• Investigators: Principal Investigator: Anne-Charlotte CULLIER, MD, CHR Metz Thionville Hopital Femme Mère Enfant

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2025
• Primary Completion (Estimated): April 8, 2027
• Study Completion (Estimated): April 8, 2027

Study Registration Dates

• First Submitted: February 28, 2025
• First Submitted That Met QC Criteria: March 7, 2025
• First Posted (Actual): March 10, 2025

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: MRI; dexmedetomidine; EEG
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Neurobehavioral Manifestations; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Leukemia, Lymphoid; Leukemia; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hemic and Lymphatic Diseases; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Agnosia; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Neurological; Electrodiagnosis; Electroencephalography
• Other Study ID Numbers: 2024-02-CHRMT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No