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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-10

Study Completion Date

2028-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cardiac Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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active RIPC and tDCS

RIPC and tDCS twice every day for 3 days before cardiac surgery

Group Type ACTIVE_COMPARATOR

No interventions assigned to this group

sham RIPC and tDCS

Sham RIPC and tDCS twice every day for 3 days before cardiac surgery

Group Type SHAM_COMPARATOR

Sham (No Treatment)

Intervention Type DEVICE

received sham treatment with the same appearance instrument;

Interventions

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active 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;

Intervention Type DEVICE

Sham (No Treatment)

received sham treatment with the same appearance instrument;

Intervention Type DEVICE

Eligibility Criteria

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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.