Transcutaneous Auricular Vagus Nerve Stimulation （taVNS）Prevents Postoperative Delirium in Elderly Patients: a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,776
- 试验地点
- 2
- 主要终点
- Incidence of POD at discharge or within 5 days postoperatively
研究概览
简要总结
According to the 3D-CAM scale, evaluate the incidence of Postoperative Delirium within 5 days after surgery in elderly patients receiving taVNS.The results are expected to provide evidence of the safety and efficacy of perioperative prophylactic use of taVNS in the clinical application of improving postoperative brain health in elderly patients, as well as theoretical and practical basis for subsequent studies or clinical applications.
详细描述
This study aims to conduct a prospective, randomized controlled clinical trial on the preventive use of taVNS to improve the incidence of Postoperative Delirium(POD) in elderly patients undergoing anesthesia surgery. The intervention group will receive "standard-stimulation parameters" of taVNS（25HZ，250μs）, while the control group will receive "low-stimulation parameters" of taVNS(1HZ,250μs). The main outcome measure of the study was the incidence of POD within 5 days after surgery. Secondary outcome measures include incidence of new mild and severe postoperative neurocognitive impairment during hospitalization and 90 days, all-cause mortality rate at 90 days, incidence of related adverse events, and length of stay.
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, Investigator, 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
- •Expected operation time≥ 2 hours
- •Postoperative hospital stay≥ 4 days
- •Sign the informed consent form
排除标准
- •Neurosurgery or cardiac surgery
- •Emergency surgery within 6 hours of admission
- •End-stage disease with an expected survival of < 3 months
- •Preoperative severe cognitive dysfunction affected perioperative cognitive function assessment
- •Severe sinus bradycardia, AVB of degree II and above, pacemaker placement
结局指标
主要结局
Incidence of POD at discharge or within 5 days postoperatively
时间窗: At discharge or within 5 days postoperatively
POD assessment was performed using the 3D-CAM scale estimate. Assessed 2 times daily until postoperative day 5 or hospital discharge
次要结局
- Incidence of delayed cognitive recovery during hospitalization(Day 1 before surgery, day 5 after surgery, day 90 after surgery)
- Incidence of neurocognitive dysfunction at 90 days postoperatively(on the 90 days)
- Degree of decline in activities of daily living at 90 days postoperatively(on the 90 days)
- All-cause mortality(on the 90 days)
- Incidence of unplanned ICU or HDU admissions(on the 90 days)
- Proportion of patients requiring higher levels of care postdischarge, specifically long-term care.(on the 90 days)
- Length of hospital stay(on the 90 days)
- Delirium severity(At discharge or within 5 days postoperatively)
研究者
Ruquan Han
professor
Beijing Tiantan Hospital