Cardiac Surgery
Conditions
Keywords
cardiac surgery, cognitive function, stroke, delirium, non-invasive neuromodulation, Remote Ischemic Preconditioning
Brief summary
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.
Interventions
DEVICEactive RIPC and tDCS
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;
DEVICESham (No Treatment)
received sham treatment with the same appearance instrument;
Sponsors
China National Center for Cardiovascular Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of neurological complications 7 (± 3) days after cardiac surgery | From enrollment to the post-surgery within 7 (±3) days | Lethal or non lethal stroke, coma, or motor impairment; Cognitive impairment or delirium |
Countries
China
Contacts
Primary ContactYao Feng, M.D.
Outcome results
None listed