Safety and Feasibility of Transauricular Vagus Nerve Stimulation in Improving 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
- 150
- 试验地点
- 2
- 主要终点
- TaVNS tolerance
研究概览
简要总结
To investigate the efficacy and safety of perioperative Transauricular vagal nerve stimulation in improving Postoperative Delirium in elderly patients undergoing elective surgery Lay the groundwork for a Phase III study.
详细描述
This study aims to conduct a prospective, randomized controlled clinical trial on the preventive use of Transauricular vagal nerve stimulation(taVNS) to improve the incidence of Postoperative Delirium(POD) in elderly patients undergoing anesthesia surgery. The intervention group will receive taVNS, while the control group will only wear a taVNS stimulator without current stimulation.
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
TaVNS tolerance
时间窗: 1-5 days after surgery
The proportion of subjects who completed all the expected interventions
Incidence of adverse events
时间窗: At discharge，an average of 2 weeks
Myocardial infarction, cardiac arrest, pulmonary embolism, infection, etc
次要结局
- Postoperative pain(1-5 days after surgery)
- Incidence of POD at discharge or within 5 days postoperatively(At discharge or within 5 days postoperatively)
- All-cause mortality(on the 90 days)
- Incidence of cognitive decline(Day 1 before surgery, day 5 after surgery, day 90 after surgery)
- Time of anesthesia recovery(Within 2 hours after the end of the surgery)
研究者
Ruquan Han
professor
Beijing Tiantan Hospital