Erythropoietin for the Prevention of Postoperative Delirium in Elderly Patients Undergoing Total Joint Arthroplasty: Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Incidence of delirium
研究概览
简要总结
Postoperative delirium is a common complication after surgery. The underlying pathophysiology of this complication is unclear, however neuroinflammation and oxidative stress secondary to surgery had shown to be the cause of postoperative cognitive dysfunction and delirium. Erythropoietin represents non-erythropoietic effects of anti-inflammatory properties. The aims of this study were to determine the role of erythropoietin toward the development of postoperative delirium, in terms of changes in inflammatory reaction by affecting the innate immunity in elderly patients undergoing total joint arthroplasty surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, 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
- •Age 65 years and older
- •Patients scheduled for elective total knee arthroplasty, total hip arthroplasty
排除标准
- •Unable to communicate
- •Cognitive impairment
- •Unable to pre-screen delirium due to underlying central nervous system disease
- •History of hypersensitivity related to erythropoietin and other anesthesia-related drugs
- •History of myocardial infarction, pulmonary infarction, cerebral infarction, ischemic vascular disease, epilpesy, chronic liver disease, chronic kidney disease
- •Uncontrolled high blood pressure
- •Within one month of starting anti-hypertensive medication
研究组 & 干预措施
Erythropoietin
500 IU/kg of EPO given intramuscularly 3 times for each patient
干预措施: Erythropoietin (Drug)
Control
Same amount of normal saline given intramuscularly 3 times for each patient
干预措施: normal saline (Drug)
结局指标
主要结局
Incidence of delirium
时间窗: 2 days post surgery, 5 days post surgery
Development of postoperative delirium determined by validated evaluation tests.
次要结局
- Inflammatory biomarker(before surgery, after surgery, 3 days post surgery day 3)