Transauricular Vagus Nerve Stimulation (taVNS) Improves Postoperative Sleep Disorders 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
- 164
- 试验地点
- 1
- 主要终点
- Incidence of sleep disorders within 5 days after surgery.
研究概览
简要总结
Postoperative sleep disorder is one of the common complications after general anesthesia. Compared to patients of various ages, elderly patients have a much higher incidence of postoperative sleep disturbance. Postoperative sleep disorders can have many adverse effects, including cognitive impairment, altered pain perception, and emotional disorders, which are not conducive to the long-term prognosis of elderly patients. Enhancing postoperative sleep quality in older patients has become a significant public health concern in the current day due to its direct relationship to both maximizing surgical outcomes and enhancing physical health. This study intends to conduct a prospective, randomized controlled, triple-blind clinical trial on use of transauricular vagal nerve stimulation to improve sleep disorders in elderly patients after general anesthesia surgery, aiming to investigate the efficacy of transauricular vagal nerve stimulation in postoperative sleep disorders in elderly patients.
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
- •Patients undergoing non-craniocerebral surgery under elective general anesthesia
- •Age ≥65 years old
- •American society of Aneshesiologists Grade I to III
- •Sign informed consent
排除标准
- •Patients who are expected to retain tracheal intubation after surgery
- •Disturbance of consciousness, mental disorder, inability to cooperate
- •Expected survival < 3 months
- •The estimated operation time is < 2 hours
- •The expected postoperative hospital stay is < 5 days
结局指标
主要结局
Incidence of sleep disorders within 5 days after surgery.
时间窗: Day 1 to day 5 after surgery.
次要结局
- Sleep quality after surgery.(Day 1,3,5 after surgery.)
- Postoperative pain score(Day1 and 2 after surgery.)
研究者
Ruquan Han
professor
Beijing Tiantan Hospital
