Non-pharmacologial, Non-invassive Intervention Before Cardiac Surgery: a Randomized Controlled Trial

China National Center for Cardiovascular Diseases200 enrolled

Overview

Perioperative neurological complications in cardiovascular surgical procedures are associated with a significant risk of mortality and disability. The goal of this clinical trial is to learn if ischemic preconditioning and transcranial electrical stimulation to reduce perioperative neurological complications. It will also learn about the safety of remote ischemic preconditioning and transcranial electrical stimulation before cardiac surgery. The main questions it aims to answer are "Do remote ischemic preconditioning and transcranial electrical stimulation make good effect on perioperative neurological complications?" "Are remote ischemic preconditioning and transcranial electrical stimulation safe?" Researchers will compare remote ischemic preconditioning and transcranial electrical stimulation to traditional treatment to see if remote ischemic preconditioning and transcranial electrical stimulation work to reduce perioperative neurological complications. Participants will:Undergo remote ischemic preconditioning and transcranial electrical stimulation or sham treatment twice every day for 3 days before surgery. Undertake psychological assessment and clinical symptom follow-up after cardiac surgery.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

200

Conditions

Cardiac Surgery

Interventions

active RIPC and tDCSDEVICE

Preoperative use of a therapeutic device with sleeves fixed on the upper side of both arms, compressing the bilateral brachial arteries to 200mmHg for 5 minutes, resting for 5 minutes, repeating 5 times, recorded as 1 time, training once in the morning and afternoon each day, and continuing treatment for at least 3 days; Administer transcranial electrical stimulation, 2mA, 30min, for 3 days;

Sham (No Treatment)DEVICE

received sham treatment with the same appearance instrument;

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age range: 18-80 years old; 2. Surgical patients with heart disease; 3. Elective surgery; 4. Patients identified as high-risk for postoperative neurological complications; Previous stroke history; Moderate to severe stenosis of the head and neck arteries was evaluated; 5. Be able to understand and comply with the requirements of clinical trial protocols, and voluntarily sign informed consent forms. Exclusion Criteria: \-

Non-pharmacologial, Non-invassive Intervention Before Cardiac Surgery: a Randomized Controlled Trial

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Central Contacts