Effect of Intraoperative Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Delirium and Negative Emotional States in Patients Undergoing Cardiac Surgery: A Multicenter, Randomized, Double-Blind, Sham-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Incidence of Postoperative Delirium
研究概览
简要总结
A multicenter, randomized, double-blind, sham-controlled trial to investigate the effects of intraoperative transcutaneous auricular vagus nerve stimulation (taVNS) on the incidence of postoperative delirium and negative emotional states (anxiety, depression) in patients undergoing elective cardiac surgery.
详细描述
Cardiac surgery is associated with a high risk of postoperative neurocognitive disorders, including delirium and negative emotional states such as anxiety and depression, which significantly impact patient recovery and long-term outcomes. This study aims to evaluate whether intraoperative taVNS, a non-invasive neuromodulation technique, can reduce the incidence and severity of these complications. Patients will be randomized to receive either active taVNS or sham stimulation during surgery. Outcomes including delirium, anxiety, depression, pain, sleep quality, recovery quality, and relevant biomarkers will be assessed postoperatively.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 85 years. Scheduled for elective cardiac surgery (e.g., CABG, valve replacement/repair). NYHA cardiac function class I-III. Willing and able to provide informed consent. Expected surgery duration ≥ 2 hours.
排除标准
- •Preoperative MMSE score < 24; severe communication barriers. History of diagnosed delirium, dementia, Parkinson's disease, schizophrenia, bipolar disorder, major depressive disorder, or long-term use of psychotropic drugs.
- •Skin lesions, infection, or deformity of bilateral ears; history of ear surgery or nerve injury; allergy to electrode materials.
- •Severe arrhythmia; implanted electronic devices (e.g., pacemaker, ICD). Participation in another interventional trial within 3 months. Other conditions deemed unsuitable by investigators.
研究组 & 干预措施
Active taVNS Group
Patients receiving active transcutaneous auricular vagus nerve stimulation during surgery.
干预措施: Active taVNS (Device)
Sham taVNS Group
Patients receiving sham (placebo) stimulation with an identical device during surgery.
干预措施: Sham taVNS Group (Device)
结局指标
主要结局
Incidence of Postoperative Delirium
时间窗: Within 7 days after surgery
Postoperative delirium will be assessed using the 3-Minute Diagnostic Interview for CAM (3D-CAM) for general ward patients and the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) for ICU patients, from postoperative day 1 to day 7. Diagnosis requires the presence of acute onset/fluctuating course and inattention, plus either disorganized thinking or altered level of consciousness.
次要结局
- Postoperative Pain Score(Postoperative day 1, 2, 3, 7, and 30)
- Postoperative Sleep Quality(Postoperative day 1, 2, 3, 7, and 30)
- Postoperative Recovery Quality(Postoperative day 7 and 30)
- Incidence and Severity of Postoperative Depression(Preoperative day, Postoperative day 1, 2, 3, 7, and 30)
- Incidence and Severity of Postoperative Anxiety(Preoperative day, Postoperative day 1, 2, 3, 7, and 30)
- Incidence and Severity of Postoperative Anxiety (HADS-A)(Preoperative day, Postoperative day 1, 2, 3, 7, and 30)
- Postoperative Agitation Score(At the time of extubation (within 24 hours post-surgery))
- Postoperative Nausea and Vomiting (PONV)(Within 3 days after extubation)
- Incidence and Severity of Postoperative Anxiety (GAD-7)(Preoperative day, Postoperative day 1, 2, 3, 7, and 30)
- Incidence and Severity of Postoperative Anxiety (SAS)(Preoperative day, Postoperative day 1, 2, 3, 7, and 30)
研究者
Weidong Mi
Director (Cheif expert of National key research and development program of China 2018YFC2001900)
Chinese PLA General Hospital