The Effect of EEG and BIS-guided Anaesthesia on the Incidence of Emergent Delirium in Children
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 monitoring, BIS monitoring.
- Кому может быть актуально
- Состояния в реестре: Emergence Delirium, Anesthesia. Базовые параметры: 1 год — 6 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
- Чехия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Comparison of the Effect of EEG and BIS-guided Anaesthesia on the Incidence of Emergent Delirium in Children: a Prospective Monocentric Study
Обзор
The aim of the study is to compare two modalities of measuring the depth of general anaesthesia on the incidence of emergent delirium in children.
Подробное описание
Preoperative preparation and the method of administering general anaesthesia will be conducted based on a standardised protocol. Each patient included in the study will be administered sedative premedication Midazolam at a dose of 0.5mg/kg per os 45-60 minutes before the operation. During transfer to the operating room, Parental Separation Anxiety Scale (PSAS) and Modified Yale Preoperative Anxiety Scale (m-YPAS) will be evaluated to assess the level of preoperative anxiety as a risk factor for emergent delirium (ED). Inhalation induction of general anaesthesia with a flow rate of 4l/min O2:air with Fio2 0.5 to achieve sufficient depth of general anaesthesia, followed by provision of peripheral venous catheter, administration of Sufentanil at a dose of 0.2uq/kg and Paracetamol 15mg/kg. Airways will be secured preferentially by a laryngeal mask, in case of leakage or the nature of the procedure by orotracheal intubation. After ensuring the airways, the gas flow is reduced to 2.5%. Immediately in the electroencephalography (EEG) group, a trained nurse connects the EEG and initiates monitoring with titration of Sevoflurane to achieve a sufficient depth of unconsciousness, which will be assessed by an EEG specialist.
In the Bispectral Index (BIS) group, the child will be equipped with a BIS electrode and the depth of general anaesthesia will be controlled with the aim of BIS values of 40-60.
The time from the start of the connection to the start of the measurement of the depth of anaesthesia, the total duration of the operation and anaesthesia will also be recorded.
During anaesthesia, in addition to vital functions, the concentration of the anaesthetic and its consumption, signs of insufficient depth of general anaesthesia will be recorded In the recovery room, scales to determine the presence of emergent delirium will be assessed - Paediatric Anesthesia Emergence Delirium scale (PAED) and Watcha scale, as well as Face, Legs, Activity, Cry, Consolability scale (FLACC) and other parameters.
Вмешательства
- Диагностический тест EEG monitoring
EEG monitoring will be performed during anaesthesia. - Диагностический тест BIS monitoring
BIS monitoring will be performed during anaesthesia.
Первичные конечные точки
- Presence of ED (in EEG and BIS groups) - PAED scale [Срок оценки: 2 hours after surgery]
- Presence of ED (in EEG and BIS groups) - Watcha scale [Срок оценки: 2 hours after surgery]
- Presence of ED (in EEG and BIS groups) - FLACC scale [Срок оценки: 2 hours after surgery]
Вторичные конечные точки (5)
- Safety of EEG and BIS monitoring in relation to ED - heart rate [Срок оценки: During general anaesthesia, up to 2 hours]
- Safety of EEG and BIS monitoring in relation to ED - blood pressure [Срок оценки: During general anaesthesia, up to 2 hours]
- Safety of EEG and BIS monitoring in relation to ED - patient movement [Срок оценки: During general anaesthesia, up to 2 hours]
- Safety of EEG and BIS monitoring in relation to ED - patient sweating [Срок оценки: During general anaesthesia, up to 2 hours]
- Safety of EEG and BIS monitoring in relation to ED - patient lacrimation [Срок оценки: During general anaesthesia, up to 2 hours]
Критерии участия
Критерии включения
- Patient aged 1-6 years indicated for surgery (hernioplasty, orchidopexy)
- Consent of parents/legal guardians
- Health status corresponding to ASA (American Society of Anesthesiologists) I and II
Критерии исключения
- Disagreement of parents/legal guardians with inclusion in the study
- Neurological disease, severe hearing and vision impairment
- Health status corresponding to ASA (American Society of Anesthesiologists) III and above
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Чехия · 1 центр
- University Hospital Ostrava — Ostrava
Идентификаторы
NCT: NCT07534215 · BisEEg study · 17/RVO-FNOs/2026