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

NCT06784583 | Completed

• 1 other identifier: [2023]342
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Coronary Artery Disease

Keywords

percutaneous coronary intervention; Vagus Nerve Stimulation; perioperative blood pressure

Outcome Measures

Primary Outcomes (1)

• Blood pressure in the catheterization laboratory.

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

  Before PCI in the catheterization laboratory

Secondary Outcomes (5)

• Incidence of perioperative hypertensive crisis

  24 hours before operation.

• Preoperative blood pressure difference

  preoperative and the previous day's 6 o'clock

• Preoperative blood pressure control rate in the catheterization laboratory.

  Operation day (before procedure)

• Difference in anxiety status

  Operation day ( before procedure)

• Safety evaluation

  Perioperative period

Study Arms (2)

transcutaneous auricular vagus nerve stimulation

EXPERIMENTAL

Device: transcutaneous auricular vagus nerve stimulation

sham transcutaneous auricular vagus nerve stimulation

SHAM COMPARATOR

Device: sham transcutaneous auricular vagus nerve stimulation

Interventions

transcutaneous auricular vagus nerve stimulation 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.

transcutaneous auricular vagus nerve stimulation

sham transcutaneous auricular vagus nerve stimulation 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.

sham transcutaneous auricular vagus nerve stimulation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guozhe Sun: lead

Study Sites (1)

First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location

MeSH Terms

Conditions

Coronary Artery Disease; Hypertension

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Yingxian Sun

  First Hospital of China Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: sub-investigator of Department of Cardiology in First Hospital of China Medical University

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 20, 2025
• Study Start: September 12, 2023
• Primary Completion: January 24, 2025
• Study Completion: March 31, 2025
• Last Updated: December 3, 2025

Record last verified: 2025-11

Locations

CN (1)