The efficacy of transcutaneous low-level vagus nerve stimulation for preventing atrial fibrillation after on-pump coronary artery bypass grafting: a randomized, double-blind, interventional study

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400080475

Enrollment

Unknown

Registered

2024-01-30

Start date

2024-02-01

Completion date

Unknown

Last updated

2024-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

the atrial fibrillation after on-pump coronary artery bypass grafting

Interventions

Active stimulation group:Patients receive active transcutaneous low-level right cymba conchae stimulation. The stimulation frequency is set to 25 Hz, pulse width in 250 µs, runs for 30 s and pauses f

Sham stimulation group:Patients received treatment of the same duration. For sham stimulation, electrodes are placed on the right cymba conchae without electrical stimulation apply.

Eligibility

Sex/Gender

All

Age

18 Years to 85 Years

Inclusion criteria

Inclusion criteria: ? Age =18 years old. ? Patients diagnosed as coronary artery disease who are admitted to Sir Run Run Shaw Hospital, Zhejiang University School of Medicine and scheduled to undergo elective on-pump coronary artery bypass grafting. ? American Society of Anesthesiologists (ASA) physical status classification I-III. ? Patients are able to understand the study procedures and various assessment scales, and communicate effectively with the researchers. ? Voluntarily participate in the study and sign for the informed consent.

Exclusion criteria

Exclusion criteria: ? Patients with permanent AF or left or right ventricular assist device implantation. ? Patients who do not require cardiopulmonary bypass. ? Patients requiring deep hypothermic circulatory arrest. ? Patients with active infection or sepsis. ? Patients on preoperative immunosuppressive medications (including steroid use). ? Patients with immunodeficiency syndrome. ? Patients with known neurological diseases. ? Patients who received vagus nerve stimulation or acupuncture treatment within 1 month prior to this study. ? Patients with ear dermatitis. ? Patients currently participating in other clinical trials. ? Vulnerable populations, including patients with psychiatric illnesses, cognitive impairment, critical illnesses, minors, pregnant women, illiterates, etc.

Design outcomes

Primary

Measure	Time frame
postoperative AF incidence;AF duration is measured by Holter monitoring recordings for 7 days postoperatively.;	—

Secondary

Measure	Time frame
demographic characteristics and basis information: height, weight, gender, age, history of hypertension, history of diabetes, and preoperative hemoglobin concentration. ;Operation time, crystalloid infusion volume, blood transfusion volume, urine output, postoperative hemoglobin concentration and duration of ICU respiratory support (hours) ;vital signs including blood pressure and heart rate.;CRP; Creatinine;prognosis and postoperative complications;IL-6;IL-10;TNF-a;	—

Measure

Time frame

demographic characteristics and basis information: height, weight, gender, age, history of hypertension, history of diabetes, and preoperative hemoglobin concentration. ;Operation time, crystalloid infusion volume, blood transfusion volume, urine output, postoperative hemoglobin concentration and duration of ICU respiratory support (hours) ;vital signs including blood pressure and heart rate.;CRP; Creatinine;prognosis and postoperative complications;IL-6;IL-10;TNF-a;

—

Countries

China

Contacts

Public ContactGang Chen

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

chengang120@hotmail.com+86 137 5711 8681

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026