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Идёт набор NCT07719712

Cognitive Dysfunction and Delirium After TUR-M in Elderly Patients

— Наблюдательное Postoperative Delirium Postoperative Cognitive Dysfunction 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: Cognitive and Delirium Assessment (MoCA and CAM).
Кому может быть актуально
Состояния в реестре: Postoperative Delirium, Postoperative Cognitive Dysfunction, 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
Turkey (Türkiye)
Следующий шаг
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Официальное название

Prediction of Postoperative Cognitive Dysfunction and Delirium: A Prospective Observational Study to Develop a Risk Score in Elderly Patients Undergoing Transurethral Resection

Обзор

Elderly patients undergoing transurethral resection are at increased risk of postoperative cognitive dysfunction (POCD) and delirium, which are associated with prolonged hospital stay, increased morbidity, and decreased quality of life. Identifying patients who are more likely to develop postoperative cognitive dysfunction or delirium remains a practical challenge in daily clinical practice. Better recognition of these patients may help tailor perioperative care and improve outcomes. This prospective observational study aims to identify perioperative factors associated with POCD and delirium in elderly patients undergoing transurethral resection and to develop a clinically applicable risk prediction model. Cognitive function and delirium are assessed using the Montreal Cognitive Assessment (MoCA) and the Confusion Assessment Method (CAM). Cognitive function and delirium will be evaluated using the Montreal Cognitive Assessment (MoCA) and the Confusion Assessment Method (CAM). The results of this study may support clinicians in recognizing vulnerable patients earlier and may contribute to more individualized perioperative management.

Подробное описание

Postoperative cognitive dysfunction (POCD) and delirium are frequently encountered in elderly patients after surgery and are linked to unfavorable clinical outcomes. Transurethral resection procedures, which are commonly performed in this age group, may further increase this risk due to both patient-related and perioperative factors.

In this prospective observational cohort, patients aged 65 years and older undergoing transurethral resection at Mugla Training and Research Hospital are followed to determine the incidence of POCD and delirium and to identify perioperative factors associated with their development.

Before surgery, demographic characteristics, comorbidities, frailty status, and baseline cognitive function are recorded. Baseline cognitive function is assessed using the Montreal Cognitive Assessment (MoCA). During surgery, the anesthesia technique, procedure duration, intraoperative hemodynamic changes, and perioperative events are recorded.

After surgery, cognitive function and delirium are assessed at predefined intervals using MoCA and the Confusion Assessment Method (CAM).

The primary objective is to identify factors independently associated with POCD and delirium. In addition, a prediction model is developed using multivariable logistic regression, and its performance is evaluated by receiver operating characteristic (ROC) analysis.

The results may help to better recognize patients at higher risk and support more tailored perioperative management strategies in elderly surgical populations.

Вмешательства

  • Диагностический тест Cognitive and Delirium Assessment (MoCA and CAM)
    Patients aged 65 years and older undergoing transurethral resection who are followed for the development of postoperative cognitive dysfunction and delirium.

Первичные конечные точки

  • Incidence of postoperative cognitive dysfunction and delirium [Срок оценки: Baseline (preoperative) and postoperative days 1, 2, and 3]
Вторичные конечные точки (2)
  • Risk factors associated with POCD and delirium [Срок оценки: From baseline (preoperative) through postoperative day 3]
  • Performance of the predictive risk model [Срок оценки: Through study completion (anticipated November 2026)]

Критерии участия

Критерии включения

  • Age ≥65 years
  • Scheduled for transurethral resection procedure
  • ASA physical status I-III
  • Able to provide informed consent
  • Adequate cognitive function to complete preoperative assessment

Критерии исключения

  • Pre-existing diagnosis of dementia or severe cognitive impairment (MoCA <18)
  • Severe visual or hearing impairment preventing cognitive assessment
  • History of psychiatric disease requiring antipsychotic or sedative medication
  • Neurological disorders associated with increased delirium risk (e.g., Parkinson's disease, epilepsy)
  • Inability to complete study assessments

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Turkey (Türkiye) · 1 центр
  • Muğla Training and Research Hospital — Muğla

Идентификаторы

NCT: NCT07719712 · 2436 / 2424 · BAKIRCAY-2025-2424

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗