Clinical trial NCT06784583: A Study on Transcutaneous Vagus Nerve Stimulation in Perioperative Period of Percutaneous Coronary Intervention
Official title: A Study on Transcutaneous Vagus Nerve Stimulation in Perioperative Period of Percutaneous Coronary Intervention: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Hypertension
Keywords: percutaneous coronary intervention
Vagus Nerve Stimulation
perioperative blood pressure
Lead sponsor: China Medical University, China
Sponsor class: OTHER
First posted: 2025-01-20
Enrollment: 494
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The blood pressure difference
timeFrame: From 1 day before the operation to the operation.
measure: perioperation blood pressure
timeFrame: From 1 day before the operation to the operation.
Secondary outcomes:
Other outcomes:
Locations:
city: Shenyang
country: China
facility: First Hospital of China Medical University
state: Liaoning
Study officials:
affiliation: First Hospital of China Medical University
name: Yingxian Sun
role: PRINCIPAL_INVESTIGATOR
References: