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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-18
SponsorCentre Hospitalier Régional Metz-Thionville

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: EEG Monitoring and PSSS clinical scoreExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
20 minutes after DEX administration

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.

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.

Time frame
20 minutes after DEX administration
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.

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.

Time frame
20 min after DEX administration
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.

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

Time frame
20 min after DEX administration
4

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

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

Other outcomes

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