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

Not Applicable

Recruiting

• Conditions: Coronary Artery Disease; Hypertension

• Registration Number: NCT06784583
• Lead Sponsor: Guozhe Sun

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2023-09-12
• Status Verified: 2025-01
• Study First Submitted: 2025-01-10
• Study First Submitted QC: 2025-01-16
• Last Update Submitted: 2025-01-16
• Study First Posted: 2025-01-20
• Last Update Posted: 2025-01-20
• Primary Completion: 2025-03-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 494

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The blood pressure difference	From 1 day before the operation to the operation.	Calculate the difference between one day before surgery and that in the operating room in two groups.
perioperation blood pressure	From 1 day before the operation to the operation.	comparation of systolic blood pressures, diastolic blood pressure and pulse between two groups during perioperation.

Trial Locations

Locations (1)

First Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China