Perioperative EEG-Monitoring and Emergence 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
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Delirium. Базовые параметры: до 16 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
- Китай
- 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
Perioperative EEG-Monitoring and Emergence Delirium in Children: a Prospective Observational Study
Обзор
Emergence delirium is a significant problem, particularly in children. However the incidence, preventative strategies, and management of emergence delirium remain unclear. Multichannel electroencephalogram is a recognized tool for identifying neurophysiologic states during anesthesia, sleep, and arousal. The aim of the current study is to evaluate the mechanisms and predictors of emergence delirium in children under 16 years scheduled for elective surgery using electroencephalogram. The "Pediatric Anesthesia Emergence Delirium Scores (PAED Score)" (Sikich et al. 2004) is used to screen for the occurrence of emergence delirium in the post anesthesia care unit.
Первичные конечные точки
- Incidence of emergence delirium [Срок оценки: Recovery from anesthetic until discharge of the child from the Post-Anesthesia Care Unit, an average of 1 hour]
Вторичные конечные точки (12)
- Relative power of each brain waves [Срок оценки: from stay at the preoperative holding room to discharge of the child from the Post-Anesthesia Care Unit, , an average of 3 hours]
- Preoperative anxiety of children [Срок оценки: baseline (At the preoperative holding room)]
- Compliance of the children during induction [Срок оценки: Procedure (At the beginning of the Induction)]
- Blood pressure [Срок оценки: During the operation, an average of 1 hour]
- Heart rate [Срок оценки: During the operation, an average of 1 hour]
- Body temperature [Срок оценки: During the operation, an average of 1 hour]
- Duration of anesthesia [Срок оценки: During the anesthesia, an average of 1 hour]
- Type of surgery [Срок оценки: During the operation]
- Duration of surgery [Срок оценки: During the operation, an average of 1 hour]
- Number of Participants with adverse events [Срок оценки: Recovery from anesthetic until discharge of the child from the Post-Anesthesia Care Unit, , an average of 1 hour]
- The level of consciousness [Срок оценки: Recovery from anesthetic until discharge of the child from the Post-Anesthesia Care Unit, an average of 1 hour]
- Postoperative pain: FLACC- Scale [Срок оценки: Recovery from anesthetic until discharge of the child from the Post-Anesthesia Care Unit, an average of 1 hour]
Критерии участия
Критерии включения
- male or female children aged under 16 years
- planned elective surgery
- informed consent by parents or legal guardians
Критерии исключения
- history of neurological or psychiatric disease
- delayed development
- inability of the parents or legal guardians to speak or read Chinese
- participation in another prospective interventional clinical study during this study
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Китай · 1 центр
- Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong Univers — Ухань
Публикации
- Sikich N, Lerman J. Development and psychometric evaluation of the pediatric anesthesia emergence delirium scale. Anesthesiology. 2004 May;100(5):1138-45. doi: 10.1097/00000542-200405000-00015. PMID 15114210
- Kain ZN, Mayes LC, Cicchetti DV, Bagnall AL, Finley JD, Hofstadter MB. The Yale Preoperative Anxiety Scale: how does it compare with a "gold standard"? Anesth Analg. 1997 Oct;85(4):783-8. doi: 10.1097/00000539-199710000-00012. PMID 9322455
- Kain ZN, Mayes LC, Wang SM, Caramico LA, Hofstadter MB. Parental presence during induction of anesthesia versus sedative premedication: which intervention is more effective? Anesthesiology. 1998 Nov;89(5):1147-56; discussion 9A-10A. doi: 10.1097/00000542-199811000-00015. PMID 9822003
- Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7. PMID 9220806
- Stargatt R, Davidson AJ, Huang GH, Czarnecki C, Gibson MA, Stewart SA, Jamsen K. A cohort study of the incidence and risk factors for negative behavior changes in children after general anesthesia. Paediatr Anaesth. 2006 Aug;16(8):846-59. doi: 10.1111/j.1460-9592.2006.01869.x. PMID 16884468
- Kerson AG, DeMaria R, Mauer E, Joyce C, Gerber LM, Greenwald BM, Silver G, Traube C. Validity of the Richmond Agitation-Sedation Scale (RASS) in critically ill children. J Intensive Care. 2016 Oct 26;4:65. doi: 10.1186/s40560-016-0189-5. eCollection 2016. PMID 27800163
Идентификаторы
NCT: NCT04091724 · TJMZK201901