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Идёт набор NCT06580028

The EEG Study Under Sevoflurane Anesthesia in Children

— Наблюдательное Electroencephalography Sevoflurane Child Neglect

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: Electroencephalography, Sevoflurane, Child Neglect. Базовые параметры: 1 Day — 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
Китай
Следующий шаг
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Официальное название

Electroencephalogram Study in Children Under Sevoflurane Anesthesia - a Prospective,Observational Study

Обзор

Sevoflurane is one of the most commonly used volatile anesthetics in children because of its rapid induction, recovery and recovery properties. Clinical studies using noninvasive brain monitoring have shown that general anesthetics and hypnotics generate electroencephalogram (EEG) oscillations in specific spatial tissues that are fundamentally related to the structure and function of neural circuits. Slow-wave-delta (0.1-4 Hz) oscillations were present in children of all ages, and the advantage of frontal α-wave oscillations appeared at approximately 6 months, began to be consistent at 10 months, and persisted at older ages. Another study, which analyzed EEG under sevoflurane general anesthesia in children aged 0-6 months, found that Theta and alpha wave power decreased with a decrease in sevoflurane concentrations in infants between 4 and 6 months of recovery. However, these studies lack detailed characterization of the neural circuit activity associated with anesthesia, especially at specific developmental ages that are highly correlated with brain plasticity. The aim of this study was to explore electroencephalogram (EEG) of children of different ages under sevoflurane general anesthesia (including anesthesia induction, maintenance and recovery) . By analyzing these EEG data in detail, we hope to be able to better understand the EEG characteristics of children of different ages under sevoflurane anesthesia, and thus develop a neurophysiology pediatric anesthesia status monitoring strategy.

Подробное описание

This study is prospective and observational. Children under sevoflurane general anesthesia were divided into 14 groups (0-3 months old, 3-6 months old, 6-9 months old, 9-12 months old, 1-1.5 years old, 1.5-2 years old, 2-2.5 years old, 2.5-3 years old, 3-3.5 years old, 3.5-4 years old, 4-4.5 years old, 4.5.5 years old, 5.5.5 years old, 5.5-6 years old) , there were 20 cases in each group. Inform the family about the research plan and obtain informed consent. To observe the time-frequency characteristics of prefrontal electroencephalogram (EEG) in children of different ages under general anesthesia with sevoflurane.

Первичные конечные точки

  • Time-frequency characteristics of electroencephalogram (EEG) [Срок оценки: during sevoflurane general anesthesia (including anesthesia induction, maintenance and recovery)]
Вторичные конечные точки (5)
  • Modified observer's assessment of alertness#sedation#MOAA/S#scale [Срок оценки: during sevoflurane general anesthesia (including anesthesia induction, maintenance and recovery)]
  • Recovery time [Срок оценки: Within up to 30 minutes after operation]
  • Pediatric anesthesia emergence delirium [Срок оценки: Within up to 30 minutes after operation]
  • The Face, Legs, Activity, Cry, Consolability Scale (FLACC) [Срок оценки: Within up to 30 minutes after operation]
  • PHBQ-AS [Срок оценки: 3 days after operation]

Критерии участия

Критерии включения

  • aged 1 days#6 years#;
  • with American Society of Anesthesiologists (ASA) physical status I or II#;
  • children requiring general anesthesia under sevoflurane;
  • parents or legal guardians of children who volunteered to participate in the trial; And signed the informed consent form.

Критерии исключения

  • Congenital malformation or other genetic conditions that are thought to affect brain development ;
  • History of severe heart, brain, liver, kidney and metabolic diseases ;
  • Premature infants (≤32 weeks);
  • Upper respiratory tract infection in the last two weeks.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical Universit — Wenzhou

Идентификаторы

NCT: NCT06580028 · SAHoWMU-CR2024-03-217

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗