NCT06791551

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: China National Center for Cardiovascular Diseases · Other Government
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiac Surgery

Interventions

Type	Name	Description
DEVICE	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;
DEVICE	Sham (No Treatment)	received sham treatment with the same appearance instrument;

Timeline

• Start date: 2025-06-10
• Primary completion: 2028-07-31
• Completion: 2028-07-31
• First posted: 2025-01-24
• Last updated: 2025-06-06

Locations

1 site across 1 country: China