Study of the Efficacy of Moderate Sedation With Intra-NAsal Dexmedetomidine Monitored by EEG MOnitoring
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: EEG.
- Кому может быть актуально
- Состояния в реестре: Procedural Sedation and Analgesia, Pediatric ALL. Базовые параметры: 1 год — 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Франция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
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).
Подробное описание
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).
Вмешательства
- Устройство 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.
Первичные конечные точки
- Prediction of complete NMRI success [Срок оценки: 20 minutes after DEX administration]
Вторичные конечные точки (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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 20 min after DEX administration]
- Correlation between PSI and PSSS scores [Срок оценки: at 0, 10, 20 and 150 minutes after DEX administration]
- Complications (Quality of recovery) [Срок оценки: at 150 minutes after DEX administration]
- Complications (Blood Pressure) [Срок оценки: at 0, 10, 20 and 150 minutes after DEX administration]
- Complications (Heart Rate) [Срок оценки: at 0, 10, 20 and 150 minutes after DEX administration]
- Complications (Oxygen Saturation) [Срок оценки: at 0, 10, 20 and 150 minutes after DEX administration]
- Complications (allergic reactions) [Срок оценки: at 0, 10, 20 and 150 minutes after DEX administration]
Критерии участия
Критерии включения
- 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).
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Диагностика
Центры проведения
Франция · 1 центр
- CHR Metz-Thionville Hopital Femme-Mère Enfant — Metz
Идентификаторы
NCT: NCT06867289 · 2024-02-CHRMT