Effects of Cognitive Intervention Therapy on Postoperative Delirium in Elderly Non-cardiac Surgical Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- incidence of postoperative delirium
研究概览
简要总结
This study is a prospective, single-center, randomized controlled trial to compare whether applying cognitive intervention therapy before and after surgery in elderly patients aged 65 years or older undergoing non-cardiac surgery can reduce the incidence of postoperative delirium compared to conservative treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
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
- •Elderly patients aged 65 and above.
- •Patients undergoing orthopedic, thoracic, or hepatopancreatobiliary surgery under general anesthesia with an expected surgery duration of 2 hours or more.
- •Patients scheduled for arterial catheterization.
排除标准
- •Patients with uncontrolled systemic conditions such as diabetes and hypertension.
- •Those with visual impairment.
- •Patients with cognitive impairment based on the MMSE-DS criteria.
- •Individuals experiencing difficulty in communication.
- •Those diagnosed with neurological disorders (such as brain hemorrhage, stroke, brain tumor, dementia, Parkinson's disease, cognitive impairment, depression, etc.).
- •Patients diagnosed with alcohol or substance addiction.
结局指标
主要结局
incidence of postoperative delirium
时间窗: from postoperative day 0 to postoperative day 7
Confusion assessment methods(CAM) will be used to assess postoperative delirium at least two times a day during the hospitalization period. Patients diagnosed with delirium using the CAM were evaluated for the duration, symptoms, and type of delirium (e.g., reduced awareness of the environment; poor cognitive skills; behavioral changes, including hallucinations, restlessness, calling out, slowed movement, or lethargy; and emotional disturbances, such as anxiety, irritability, euphoria, apathy, unpredictable mood shift, and personality changes).
次要结局
- type of delirium(from postoperative day 0 to postoperative day 7)
- comprehensive geriatric assessment(CGA),(from postoperative day 0 to postoperative day 7)
- duration of delirium(from postoperative day 0 to postoperative day 7)
- total score of QOR-40(from postoperative day 0 to postoperative day 7)