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
- 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 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.
研究组 & 干预措施
control group
The entire process is carried out according to Severance Hospital surgical protocols.
干预措施: control group (Procedure)
intervention group
The entire process is carried out according to Severance Hospital surgical protocols. The patients of control group will receive education from the research team about the importance of nutrition and exercise before and after surgery. In addition, the patients of control group will be instructed to take up to 4 doses of the nutritional supplement (Nucare Curact provided by DAESANG Wellife Inc.) per day for approximately 2 weeks before surgery and for about 4 weeks after surgery.
干预措施: Nucare Curact group (Dietary Supplement)
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
- 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)
- type 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)