Postoperative Atrial Fibrillation in Valve Surgery under Cardiopulmonary Bypass
Conditions
Interventions
Sham stimulation group:Patients receive treatment of the same duration. For sham stimulation, electrodes are placed on the right cymba conchae without electrical stimulation applied.
Sponsors
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Age >=18 years; 2. Diagnosed as valvular heart disease and scheduled for elective mitral and/or aortic valve surgery under general anesthesia with cardiopulmonary bypass; 3. American Society of Anesthesiologists (ASA) classification 1-3; 4. Patients are capable of understanding the study procedures and using various assessment tools, and be able to communicate effectively with the research team; 5. Voluntarily participating in this study and signing the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with permanent atrial fibrillation or implantation of left or right ventricular assist devices; 2. Patients who do not require cardiopulmonary bypass; 3. Patients requiring deep hypothermic circulatory arrest; 4. Patients with active infection or sepsis; 5. Preoperative use of immunosuppressive drugs (including steroids); 6. Patients with immunodeficiency syndrome; 7. Patients with known neurological disorders; 8. Patients currently participating in other clinical trials; 9. Patients with auricular dermatitis; 10. History of seizures or syncope within the last 5 years; 11. Patients who have undergone vagus nerve stimulation or acupuncture treatment in the month preceding the study; 12. Vulnerable populations, including those with mental illness, cognitive impairment, critically ill patients, minors, pregnant women, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| postoperative AF incidence;AF duration was measured based on Holter monitoring recordings for 7 days postoperatively.; | — |
Secondary
| Measure | Time frame |
|---|---|
| patients demographic information and baseline: height, weight, gender, age, history of hypertension, history of diabetes, and preoperative hemoglobin concentration. ;Operation duration, cardiopulmonary bypass duration, crystalloid infusion volume, blood transfusion volume, urine output, postoperative hemoglobin concentration and respiratory supporting duration in ICU (hours) ;Vital signs including blood pressure and heart rate in four time-frames.;CRP;Creatinine;IL-6;IL-10;TNF-a;prognosis; | — |
Countries
China
Contacts
Public ContactGang Chen
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Outcome results
None listed