Effects of Nutritional Support on Postoperative Delirium (POD) in Elderly Non-cardiac Surgical patients_non-inferiority Comparison
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 314
- 试验地点
- 2
- 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 nutritional supplementation therapy before and after surgery in elderly patients aged 65 years or older undergoing non-cardiac surgery can reduce the incidence of postoperative delirium.
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
- 是
入选标准
- •Elderly patients aged 65 and above.
- •Patients undergoing non-cardiac major surgery in thoracic surgery, lung cancer surgery, multi-level spinal surgery in neurosurgery and orthopedics, or liver cancer surgery in hepatobiliary and pancreatic surgery, under general anesthesia with an expected surgery duration of 2 hours or more.
- •Patients scheduled for arterial catheterization.
- •Patients who are able to take oral intake from postoperative day #1.
排除标准
- •Patients with uncontrolled systemic conditions such as diabetes, hypertension, renal disease, liver disease, and other systemic illnesses.
- •Those with visual impairment.
- •Patients with cognitive impairment based on the Mini-Mental State Examination for Dementia Screening 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.
- •Patients with cancelled scheduled surgeries.
- •Patients undergoing minor surgeries with expected anesthesia durations of less than 2 hours.
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 for diagnosing 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; and emotional disturbances). \*\* Confusion assessment methods(CAM) diagnostic algorism (positive or negative result, positive means delirium) CAM is considered positive if features 1 and 2 are present, with at least one of features 3 or 4. Below are the four criteria of features : 1. Acute onset and fluctuating course Determined by collateral history or repeated clinic assessment 2. Inattention Counting from 20-1 is a simple (if blunt) test for this 3. Disorganized thinking 4. Altered levels of consciousness
次要结局
- type of delirium(from postoperative day 0 to postoperative day 7)
- GDS for depression(from postoperative day 0 to postoperative day 7)
- IADL for independence(from postoperative day 0 to postoperative day 7)
- duration of delirium(from postoperative day 0 to postoperative day 7)
- K-FRAIL for frailty(from postoperative day 0 to postoperative day 7)
- ADL for independence(from postoperative day 0 to postoperative day 7)
- QOR-40 for recovery(from postoperative day 0 to postoperative day 7)
- SNSB-c for cognitive dysfunction(from postoperative day 0 to postoperative day 7)
- K-MoCA for cognitive dysfunction(from postoperative day 0 to postoperative day 7)