跳至主要内容
临床试验/NCT07719712
NCT07719712招募中不适用

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

Muğla Sıtkı Koçman University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2026年4月5日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
150
试验地点
1
主要终点
Incidence of postoperative cognitive dysfunction and delirium

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

结局指标

主要结局

Incidence of postoperative cognitive dysfunction and delirium

时间窗: Baseline (preoperative) and postoperative days 1, 2, and 3

Postoperative cognitive dysfunction and delirium assessed using the Montreal Cognitive Assessment (MoCA) and the Confusion Assessment Method (CAM). POCD is defined as a decline in MoCA score compared with baseline, and delirium is identified based on CAM criteria.

次要结局

  • Risk factors associated with POCD and delirium(From baseline (preoperative) through postoperative day 3)
  • Performance of the predictive risk model(Through study completion (anticipated November 2026))

研究者

发起方
Muğla Sıtkı Koçman University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Eylem Yaşar

Anesthesiologist

Muğla Sıtkı Koçman University

研究点 (1)

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