NCT03989375尚未招募不适用
The Effect of Transcutaneous Electrical Stimulation of the Vagus Nerve on Reduction of Postoperative Cognitive Dysfunction in Elderly Patients After Hip or Knee Arthroplasty
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Incidence of perioperative neurocognitive disorders
研究概览
简要总结
This study evaluate the cognitive functions of patient after hip or kneel replacement.Half of the patient will receive transcutaneous vagus nerve electrical stimulation during the surgery while the other half will get placebo therapy
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •over 65 years old
- •ability to communication
- •hip or kneel replacement
- •willing to participate in the study
排除标准
- •with cerebral disorders or disease
- •cognitive impairment before surgery
- •with mental disease
- •unable to communication
- •severe eyes or ears impairment
- •surgery performed in the past 30 days
- •Bradycardia，II°AVB，III°AVB，severe heart, liver and kidney dysfunction
- •severe skin disease
- •refuse to enter the study
研究组 & 干预措施
experiment group
Experimental
干预措施: transcutaneous vagus nerve electric stimulator (Device)
control group
No Intervention
结局指标
主要结局
Incidence of perioperative neurocognitive disorders
时间窗: one month
make different scale before and after operation to evaluate neurocognitive changes in experiment group and control group.
次要结局
未报告次要终点
研究者
研究点 (1)
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