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NCT Number: NCT06867289

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

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).

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Key information

Conditions

Procedural Sedation and Analgesia Agnosia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Pediatric ALL Perceptual Disorders Precursor Cell Lymphoblastic Leukemia-Lymphoma Signs and Symptoms

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHR Metz-Thionville Hopital Femme-Mère Enfant

Metz, 57085, France

Location status: Recruiting

Location contact

Anne-Charlotte CULLIER, MD

PRINCIPAL_INVESTIGATOR

Arpiné EL NAR, PhD

CONTACT

[email protected]

0033387557766

Claire BILBAULT, MD

SUB_INVESTIGATOR

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Prediction of complete NMRI success

    Time frame: 20 minutes after DEX administration

    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.

Secondary outcomes

  1. 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

    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.

  2. 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

    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.

  3. 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

    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

  4. Correlation between PSI and PSSS scores

    Time frame: at 0, 10, 20 and 150 minutes after DEX administration

    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

  5. Complications (Quality of recovery)

    Time frame: at 150 minutes after DEX administration

    PSSS score: ranges from 0 (deepest sedation) to 5 (shallowest sedation) depending on the observation of clinical signs in children

  6. Complications (Blood Pressure)

    Time frame: at 0, 10, 20 and 150 minutes after DEX administration

    mmHg

  7. Complications (Heart Rate)

    Time frame: at 0, 10, 20 and 150 minutes after DEX administration

    bpm

  8. Complications (Oxygen Saturation)

    Time frame: at 0, 10, 20 and 150 minutes after DEX administration

    SaO2 (%)

  9. Complications (allergic reactions)

    Time frame: at 0, 10, 20 and 150 minutes after DEX administration

    number and types

Study contacts

Contact information is provided by the study sponsor or research team.

Arpiné EL NAR, PhD

CONTACT

[email protected]

0033387557766

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional Metz-Thionville

Other

Registry information

Acronym: DINAMO

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 10, 2025
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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