Non-pharmacologial, Non-invassive Intervention Before Cardiac Surgry: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The incidence of neurological complications 7 (± 3) days after cardiac surgery
研究概览
简要总结
Perioperative neurological complications in cardiovascular surgical procedures are associated with a significant risk of mortality and disability. The goal of this clinical trial is to learn if ischemic preconditioning and transcranial electrical stimulation to reduce perioperative neurological complications. It will also learn about the safety of remote ischemic preconditioning and transcranial electrical stimulation before cardiac surgery. The main questions it aims to answer are "Do remote ischemic preconditioning and transcranial electrical stimulation make good effect on perioperative neurological complications?" "Are remote ischemic preconditioning and transcranial electrical stimulation safe?" Researchers will compare remote ischemic preconditioning and transcranial electrical stimulation to traditional treatment to see if remote ischemic preconditioning and transcranial electrical stimulation work to reduce perioperative neurological complications.
Participants will:Undergo remote ischemic preconditioning and transcranial electrical stimulation or sham treatment twice every day for 3 days before surgery.
Undertake psychological assessment and clinical symptom follow-up after cardiac surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range: 18-80 years old;
- •Surgical patients with heart disease;
- •Elective surgery;
- •Patients identified as high-risk for postoperative neurological complications; Previous stroke history; Moderate to severe stenosis of the head and neck arteries was evaluated;
- •Be able to understand and comply with the requirements of clinical trial protocols, and voluntarily sign informed consent forms.
排除标准
- 未提供
研究组 & 干预措施
active RIPC and tDCS
RIPC and tDCS twice every day for 3 days before cardiac surgery
sham RIPC and tDCS
Sham RIPC and tDCS twice every day for 3 days before cardiac surgery
干预措施: Sham (No Treatment) (Device)
结局指标
主要结局
The incidence of neurological complications 7 (± 3) days after cardiac surgery
时间窗: From enrollment to the post-surgery within 7 (±3) days
Lethal or non lethal stroke, coma, or motor impairment; Cognitive impairment or delirium
次要结局
未报告次要终点
研究者
Shujuan Li
M.D.
China National Center for Cardiovascular Diseases