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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| transcutaneous auricular vagus nerve stimulation | Experimental |
| |
| sham transcutaneous auricular vagus nerve stimulation | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcutaneous auricular vagus nerve stimulation | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of perioperative hypertensive crisis | 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. | 24 hours before operation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yingxian Sun | First Hospital of China Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Hospital of China Medical University | Shenyang | Liaoning | 110001 | China |
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|
| sham transcutaneous auricular vagus nerve stimulation | Device |
|
|
| Preoperative blood pressure difference |
The difference between the preoperative and the previous day's 6 o'clock blood pressure in the catheterization laboratory |
| preoperative and the previous day's 6 o'clock |
| Preoperative blood pressure control rate in the catheterization laboratory. | Mean preoperative blood pressure <140/90 mmHg in the catheterization laboratory was recorded as achieved; | Operation day (before procedure) |
| Difference in anxiety status | 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. | Operation day ( before procedure) |
| Safety evaluation | 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. | Perioperative period |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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