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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EEG Monitoring and PSSS clinical score | Experimental | All participants receive an EEG monitoring. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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:
PSI score: evaluated on EEG, the score varies from 0 to 100. | 20 minutes after DEX administration |
| 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:
|
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Inclusion Criteria:
Indication of DEX sedation for brain NMRI at the CHR de Metz-Thionville
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
Patients with nasal obstruction
Parental refusal of DEX administration
Minors under guardianship
Minors under judicial sanction
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arpiné EL NAR, PhD | Contact | 0033387557766 | projet-recherche-clinique@chr-metz-thionville.fr |
| Name | Affiliation | Role |
|---|---|---|
| Anne-Charlotte CULLIER, MD | CHR Metz Thionville Hopital Femme Mère Enfant | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHR Metz-Thionville Hopital Femme-Mère Enfant | Recruiting | Metz | 57085 | France |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D004569 | Electroencephalography |
| ID | Term |
|---|---|
| D003943 | Diagnostic Techniques, Neurological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004568 | Electrodiagnosis |
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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.
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|
| 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:
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:
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 |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |