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Идёт набор NCT05555693

Correlation Between Postoperative Cognitive-related Adverse Reactions and Brain Metabolomic Characteristics in Elderly Patients

— Наблюдательное POCD - Postoperative Cognitive Dysfunction

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: Collecting clinical data, EGG，Brain Metabolomic Characteristics(with Magnetic Resonance Spectroscopy), blood gas data and blood sample.
Кому может быть актуально
Состояния в реестре: POCD - Postoperative Cognitive Dysfunction. Базовые параметры: от 65 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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Обзор

Postoperative cognitive dysfunction (POCD) refers to the difficulties of orientation, cognition, communication, memory and abstract thinking of patients after anesthesia and surgery. And/or accompanied by the decline of the ability in social activities, such as the change of personality, social ability of language and behavior, cognitive function and life skills. POCD is a common complication of central nervous system in elderly patients after operation, with an early incidence of about 21% and a long-term incidence of about 35% . According to the current research on Alzheimer's disease (AD) and POCD in the elderly, it has been found that they have similar pathological basis and some homologous related genes. Altogether, POCD is closely related to molecular pathway neuropsychiatric diseases (such as dementia, depression and Alzheimer's disease). Researchers have come up with various hypotheses to reveal the underlying mechanisms of POCD, including neuritis, oxidative stress, autophagy disorder, synaptic dysfunction, and lack of neurotrophic support. To date, apart from evaluating with scales, CT Scan and EEG analysis, there is neither exact biomarkers for monitoring and diagnosing POCD, nor clear relationships between specific Brain Metabolomic Characteristics, EEG changes and diagnosis of POCD, so that the diagnosis of early POCD only stays in the evaluation of clinical symptoms and scales. Therefore, our study aims to provide an effective basis for early diagnosis and treatment of clinical POCD through multivariate analyses of clinical scales combined with Brain Metabolomic Characteristics, EEG analysis of patients.

Вмешательства

  • Другое Collecting clinical data, EGG，Brain Metabolomic Characteristics(with Magnetic Resonance Spectroscopy), blood gas data and blood sample
    Collecting clinical data(before induction of anesthesia and first day after surgery), EGG（first day after surgery），Magnetic Resonance Spectroscopy data (before induction of anesthesia and first day after surgery)blood gas data(before induction of anesthesia and first day after surgery) and blood sample （before induction of anesthesia and first day, third day and 7th day after surgery）

Первичные конечные точки

  • MMSE (mini-mental state examiniation) [Срок оценки: 1 day after surgery]
  • MMSE (mini-mental state examiniation) [Срок оценки: immediately before surgery]
  • MMSE (mini-mental state examiniation) [Срок оценки: 3 day after surgery]
  • MMSE (mini-mental state examiniation) [Срок оценки: 7 day after surgery]
  • MOCA (Montreal Cognitive Assessment) [Срок оценки: 1 day after surgery]
  • MOCA (Montreal Cognitive Assessment) [Срок оценки: 3 day after surgery]
  • MOCA (Montreal Cognitive Assessment) [Срок оценки: 7 day after surgery]
  • MOCA (Montreal Cognitive Assessment) [Срок оценки: immediately before surgery]
Вторичные конечные точки (3)
  • 3D-CAM [Срок оценки: 1 day after surgery]
  • Self-Rating Anxiety Scale [Срок оценки: immediately before surgery]
  • Self-rating depression scale [Срок оценки: immediately before surgery]

Критерии участия

Критерии включения

  • 65 years or older .
  • Complete the operation in our hospital
  • ASA classification I-II level
  • Agree to participate in this research and agree to sign an informed consent form

Критерии исключения

  • History of preoperative psychosis and psychotropic drug use
  • The subject is diagnosed with AD;
  • Abnormal preoperative mental scale assessment
  • Have a history of emergency rescue during the perioperative period
  • metal implants
  • Postoperative immobilization patients

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
  • Shanghai 9Th Hospital — Шанхай

Идентификаторы

NCT: NCT05555693 · SH9H-2022-T133-2

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗