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

NCT06784583 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2025-12-03

No results posted yet for this study

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

Interventions

DEVICE

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.

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.

Sponsors & Collaborators

  • Guozhe Sun

    lead OTHER

Principal Investigators

  • Yingxian Sun · First Hospital of China Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-12
Primary Completion
2025-01-24
Completion
2025-03-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06784583 on ClinicalTrials.gov