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

Guozhe Sun

Status

Completed

Conditions

Hypertension

Coronary Artery Disease

Treatments

Device: sham transcutaneous auricular vagus nerve stimulation

Device: transcutaneous auricular vagus nerve stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT06784583

[2023]342

Details and patient eligibility

About

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.

Full 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.

Enrollment

480 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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