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

NCT ID: NCT06784583

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 480 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-12
• Study Completion Date: 2025-03-31

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.

Conditions

Coronary Artery Disease; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

transcutaneous auricular vagus nerve stimulation

Group Type: EXPERIMENTAL

transcutaneous auricular vagus nerve stimulation

Intervention Type: DEVICE

1. Prior to execution: Remove jewelry (such as earrings) that may interfere with the electrode placement; attach the electrodes to the tragus of the left ear; feed the wires over the right shoulder from the back of the neck, and then turn on the device.

2. Initiate stimulation: Establish the following parameters: 200 μs pulse width, 30 Hz frequency, 0-36 mA current intensity (modify to the most appropriate stimulation intensity based on the patient's pain perception), and one-hour timing. Next, begin the stimulation.

3. Stimulation end: After an hour, the device will be automatically switched off. And the procedure is finished.

sham transcutaneous auricular vagus nerve stimulation

Group Type: SHAM_COMPARATOR

sham transcutaneous auricular vagus nerve stimulation

Intervention Type: DEVICE

1. Prior to execution: Remove jewelry (such as earrings) that may interfere with the electrode placement; attach the electrodes to the tragus of the left ear; feed the wires over the right shoulder from the back of the neck, and then turn on the device.

2. Initiate stimulation: Establish the following parameters: 200 μs pulse width, 30 Hz frequency, 0-36 mA current intensity (modify to the most appropriate stimulation intensity based on the patient's pain perception). Next, turn off the stimulation，and one-hour timing.

3. Stimulation end: After an hour, the device will be removed and the procedure is finished.

Interventions

transcutaneous auricular vagus nerve stimulation

1. Prior to execution: Remove jewelry (such as earrings) that may interfere with the electrode placement; attach the electrodes to the tragus of the left ear; feed the wires over the right shoulder from the back of the neck, and then turn on the device.

2. Initiate stimulation: Establish the following parameters: 200 μs pulse width, 30 Hz frequency, 0-36 mA current intensity (modify to the most appropriate stimulation intensity based on the patient's pain perception), and one-hour timing. Next, begin the stimulation.

3. Stimulation end: After an hour, the device will be automatically switched off. And the procedure is finished.

Intervention Type: DEVICE

sham transcutaneous auricular vagus nerve stimulation

1. Prior to execution: Remove jewelry (such as earrings) that may interfere with the electrode placement; attach the electrodes to the tragus of the left ear; feed the wires over the right shoulder from the back of the neck, and then turn on the device.

2. Initiate stimulation: Establish the following parameters: 200 μs pulse width, 30 Hz frequency, 0-36 mA current intensity (modify to the most appropriate stimulation intensity based on the patient's pain perception). Next, turn off the stimulation，and one-hour timing.

3. Stimulation end: After an hour, the device will be removed and the procedure is finished.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guozhe Sun

OTHER

Sponsor Role: lead

Responsible Party

Guozhe Sun

sub-investigator of Department of Cardiology in First Hospital of China Medical University

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yingxian Sun

Role: PRINCIPAL_INVESTIGATOR

First Hospital of China Medical University

Locations

First Hospital of China Medical University

Shenyang, Liaoning, China

Countries

China

Other Identifiers

[2023]342

Identifier Type: -

Identifier Source: org_study_id