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A Study on Transcutaneous Vagus Nerve Stimulation in Perioperative Period of Percutaneous Coronary Intervention

A Study on Transcutaneous Vagus Nerve Stimulation in Perioperative Period of Percutaneous Coronary Intervention

Not Recruiting
18-70 years
All
Phase N/A

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Overview

The goal of this clinical trial is to study the effect of transcutaneous auricular vagus nerve stimulation on perioperative blood pressure.

The main question it aims to answer is:

•Wether the transcutaneous auricular vagus nerve stimulation have advantages in perioperative blood pressure elevation.

Participants will sign an informed consent form, collaborate with data collection, and are randomly divided into two groups(1:1) to accept the intervention measures from corresponding groups. Researchers will record the perioperative blood pressure and compare intervention group with sham group to see if there is any difference in perioperative blood pressure.

Description

Sharp variations in blood pressure are more common in patients with hypertension. In non-cardiac procedures, up to 25% of patients will experience perioperative hypertension, which raises the risk of bleeding, cerebrovascular accidents, and cardiovascular events. Significant contributing factors include excessive sympathetic nerve activation, intraoperative and postoperative discomfort, and patient anxiety prior to surgery. The primary cause of perioperative hypertension is the malfunction of arterial dilatation and contraction brought on by renin-angiotensin system activation, which offers fresh approaches to perioperative blood pressure management.

Numerous research conducted in recent years have demonstrated that auricular stimulation of the vagus nerve can also have a number of effects on different parts of the brain, resulting in the regulation of the autonomic nerve balance in the heart. In healthy people, transcutaneous vagus nerve stimulation can lower cardiovascular sympathetic nerve excitability and control the sensitivity of baroreceptor reflexes, both of which are crucial for blood pressure regulation.

Eligibility

Inclusion Criteria:

  • Ages between 18 and 70 years old, regardless of gender
  • Patients with indications for coronary artery stent implantation
  • hypertension history
  • Voluntarily participate and sign an informed consent form

Exclusion Criteria:

  • Patients with acute myocardial infarction
  • Patients with heart failure of NYHA class III - IV
  • Patients with atrial fibrillation (indicated by definite medical history or electrocardiogram on admission)
  • Patients with a medical history of hyperthyroidism
  • Patients with subclavian artery occlusion (indicated by definite medical history or a difference in systolic blood pressure of more than 20 mmHg between the two upper limbs)
  • With an estimated glomerular filtration rate (eGFR) of less than 60 ml/min/1.73m² on admission
  • Patients with infections and fever
  • Patients who are unable to cooperate due to mental and psychological disorders (such as mania, depression)
  • Patients with tinnitus and vertigo
  • Pregnant women or patients who are attempting to get pregnant
  • Patients participating in clinical trials of other drugs or medical devices
  • Patients deemed unsuitable by the researchers to participate in this clinical trial

Study details
    Coronary Artery Disease
    Hypertension

NCT06784583

Guozhe Sun

12 December 2025

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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