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COMPLETED
NCT07853222
NA

Vagus Nerve Stimulation for Autonomic Modulation After Coronary Artery Bypass Graft Surgery

Sponsor: Hospital de Clinicas de Porto Alegre

View on ClinicalTrials.gov

Summary

The objective of this randomized clinical trial is to investigate whether transcutaneous auricular vagus nerve stimulation (taVNS) can improve the recovery of patients undergoing coronary artery bypass grafting (CABG) through autonomic modulation, while also evaluating the safety of the intervention. The main questions this study aims to answer are: * Does taVNS improve autonomic modulation, as assessed by heart rate variability, in patients undergoing CABG? * Does taVNS reduce the inflammatory response and pain intensity while improving quality of life and functional capacity during the postoperative period? * Is taVNS a safe and well-tolerated intervention during recovery after CABG? The researchers will compare taVNS with a control group (sham stimulation/placebo) to determine whether the intervention leads to better clinical and functional outcomes in patients undergoing coronary artery bypass grafting. Participants will: * Receive sessions of transcutaneous auricular vagus nerve stimulation (taVNS) or sham stimulation (placebo), according to the study randomization. * Undergo assessments of autonomic modulation using heart rate variability before and after the intervention. * Be evaluated for inflammatory markers, pain intensity, quality of life, and functional capacity at different time points during the postoperative period.

Official title: Vagus Nerve Stimulation for Autonomic Modulation in Patients Undergoing Coronary Artery Bypass Grafting: A Randomized Clinical Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

58

Start Date

2025-08-31

Completion Date

2026-06-30

Last Updated

2026-10-01

Healthy Volunteers

No

Interventions

DEVICE

Transcutaneous auricular vagus nerve stimulation

Transcutaneous auricular vagus nerve stimulation (taVNS) will be performed daily for 30 minutes until hospital discharge. One electrode will be placed on the auricular concha to stimulate the auricular branch of the vagus nerve, and the other electrode will be positioned on the left earlobe to stimulate the great auricular nerve. The stimulation will be delivered using the EL-30 device (NKL Produtos Eletrônicos, Brusque, SC, Brazil), with a pulse width of 250 μs, intensity below the pain threshold, and alternating frequencies of 2 Hz for 5 seconds and 15 Hz for 5 seconds. The stimulation sites were selected based on auricular innervation, technical feasibility, and treatment standardization.The control group will use the same device; however, no active electrical current will be delivered (placebo stimulation).

Locations (2)

Hospital de Clinicas de Ijuí

Ijuí, Rio Grande do Sul, Brazil

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil