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Transcutaneous Auricular Vagus Nerve Stimulation to Prevent and Mitigate Myocardial Injury Following Cardiopulmonary Bypass–Assisted Valve Surgery: A Randomized, Double-Blind, Controlled Trial

Transcutaneous Auricular Vagus Nerve Stimulation to Prevent and Mitigate Myocardial Injury Following Cardiopulmonary Bypass–Assisted Valve Surgery: A Randomized, Double-Blind, Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600119104
Enrollment
Unknown
Registered
2026-02-20
Start date
2026-04-27
Completion date
Unknown
Last updated
2026-08-10

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

Conditions

Perioperative myocardial injury

Interventions

Active ta-VNS group:In the active ta-VNS group, patients will undergo stimulation of the left cymba conchae. Stimulation will be delivered at a frequency of 25 Hz and a pulse width of 250 µs, with a d
Sham ta-VNS group:In the sham stimulation group, participants will undergo the same intervention protocol
however, the electrical stimulation device will be powered off after the intensity adjustment procedure. All devices will be labeled to ensure that each participant uses the same device throughout all

Sponsors

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

Eligibility

Sex/Gender
All
Age
40 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Age between 40 and 85 years; 2. Scheduled for elective mitral and/or aortic valve surgery under general anesthesia with cardiopulmonary bypass, with or without concomitant tricuspid valve procedures; 3. Physical status classification I–III according to the American Society of Anesthesiologis 4. Functional class I–III according to the New York Heart Association; 5. Provided written informed consent and agreed to participate in the study.

Exclusion criteria

Exclusion criteria: 1. Left ventricular ejection fraction (LVEF) 0.3 µg/kg/min); 8. Cerebrovascular events within the preceding 6 months; 9. Epileptic seizures or recurrent syncope within the past 5 years; 10. Exposure to vagus nerve stimulation or acupuncture therapy within 1 month before study enrollment.

Design outcomes

Primary

MeasureTime frame
hs-cTn I;

Secondary

MeasureTime frame
hs-cTn I;NT-proBNP;CK-MBm;Inflammatory markers (WBC, CRP);creatinine;

Countries

China

Contacts

Public ContactZhang Jun

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

3316088@zju.edu.cn+86 137 5089 1365

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 25, 2026