跳至主要内容
临床试验/NCT06421051
NCT06421051招募中不适用

Transauricular Vagus Nerve Stimulation (taVNS) Improves Postoperative Sleep Disorders in Elderly Patients:a Randomized Controlled Study.

Beijing Tiantan Hospital1 个研究点 分布在 1 个国家目标入组 164 人开始时间: 2024年6月20日最近更新:
适应症

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

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

发起方
Beijing Tiantan Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ruquan Han

professor

Beijing Tiantan Hospital

研究点 (1)

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