Postoperative atrial fibrillation (POAF) is a common complication after coronary artery bypass surgery and may be associated with prolonged hospitalization and adverse cardiovascular outcomes. Transcutaneous auricular vagus nerve stimulation (taVNS) is a noninvasive neuromodulation technique that delivers mild electrical stimulation to the ear and may help regulate autonomic and inflammatory responses. This randomized controlled trial will evaluate whether perioperative taVNS can reduce the incidence of POAF in adults undergoing elective off-pump coronary artery bypass grafting (OPCAB). Participants will be randomly assigned in a 1:1 ratio to receive either taVNS in addition to standard perioperative care or standard perioperative care alone. The primary outcome is the incidence of new-onset atrial fibrillation within 7 days after surgery. Secondary outcomes will include atrial fibrillation burden, inflammatory markers, heart rate variability, use of antiarrhythmic and anticoagulant medications, safety, length of hospital stay, and major adverse cardiovascular events during follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
410
Transcutaneous auricular vagus nerve stimulation (taVNS) will be delivered using the taVNS device. Stimulation will be applied to the left auricular region targeting the auricular branch of the vagus nerve. The stimulation frequency will be 20 Hz with a pulse width of approximately 200 μs. Stimulation intensity will be gradually increased from zero to the highest level that is comfortably tolerated without pain. Participants will receive two stimulation sessions per day, separated by at least 4-6 hours, beginning 1 days before surgery and continuing through postoperative day 7. Each session will last 60 minutes. Standard perioperative care for off-pump coronary artery bypass grafting will be provided concurrently.
Incidence of New-Onset Postoperative Atrial Fibrillation Within 7 Days After OPCAB
The proportion of participants who develop new-onset postoperative atrial fibrillation (POAF) after off-pump coronary artery bypass grafting. POAF is defined as an episode of atrial fibrillation lasting at least 30 seconds, detected by continuous electrocardiographic monitoring, Holter monitoring, or telemetry. Events will be adjudicated by outcome assessors blinded to treatment allocation.
Time frame: From the end of surgery through postoperative day 7
Duration of Postoperative Atrial Fibrillation
Total duration of postoperative atrial fibrillation episodes detected by continuous electrocardiographic monitoring during the first 7 days after surgery.
Time frame: From the end of surgery through postoperative day 7
Change in Circulating Inflammatory Markers
Changes in serum interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), and C-reactive protein (CRP) levels will be assessed to evaluate the perioperative inflammatory response.
Time frame: Baseline and postoperative 24, 72 and 120 hours
Heart Rate Variability
Heart rate variability will be assessed using Holter monitoring, including SDNN and RMSSD as measures of autonomic function.
Time frame: From the end of surgery through postoperative day 7
Use of Antiarrhythmic Medication for Postoperative Atrial Fibrillation
Proportion of participants requiring antiarrhythmic medication for treatment of postoperative atrial fibrillation, including drugs such as amiodarone.
Time frame: Through postoperative day 7
Initiation of Anticoagulation for Postoperative Atrial Fibrillation
Proportion of participants in whom anticoagulant therapy is initiated because of postoperative atrial fibrillation.
Time frame: Through postoperative day 7
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