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NCT Number: NCT06784583

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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Hypertension Myocardial Ischemia Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcutaneous Auricular Vagus Nerve Stimulation

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

Sham transcutaneous auricular vagus nerve stimulation

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

Primary outcomes

  1. Blood pressure in the catheterization laboratory.

    Time frame: Before PCI in the catheterization laboratory

    comparation of systolic blood pressures, diastolic blood pressure and pulse between two groups in the catheterization laboratory.

Secondary outcomes

  1. Incidence of perioperative hypertensive crisis

    Time frame: 24 hours before operation.

    Mean preoperative systolic blood pressure in the catheterization laboratory of ≥180 mmHg and/or diastolic blood pressure of ≥110 mmHg and/or temporary pharmacologic intervention for significantly elevated blood pressure 24 hours before operation.

  2. Preoperative blood pressure difference

    Time frame: preoperative and the previous day's 6 o'clock

    The difference between the preoperative and the previous day's 6 o'clock blood pressure in the catheterization laboratory

  3. Preoperative blood pressure control rate in the catheterization laboratory.

    Time frame: Operation day (before procedure)

    Mean preoperative blood pressure <140/90 mmHg in the catheterization laboratory was recorded as achieved;

  4. Difference in anxiety status

    Time frame: Operation day ( before procedure)

    The anxiety status of subjects in the catheterization laboratory was evaluated using the Visual Analog Scale (VAS). This scale ranges from 0 to 10 points (with the minimum score of 0 and the maximum score of 10), and higher scores indicate a higher level of anxiety.

  5. Safety evaluation

    Time frame: Perioperative period

    Procedure-related adverse events and device-related adverse events; the former included Major Adverse Cardiac Events (MACE) (all-cause mortality, myocardial infarction, target vessel revascularization, and stroke) and intraoperative antihypertensive medication interventions; device-related adverse events included irritation site itching and tingling, and vagal reflex.

Sponsors and collaborators

Lead sponsor

Guozhe Sun

Other

Registry information

Official study title

A Study on Transcutaneous Vagus Nerve Stimulation in Perioperative Period of Percutaneous Coronary Intervention: A Randomized Clinical Trial

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 20, 2025
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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