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Effect of Perioperative re-Transcranial Electrical Stimulation on Postoperative Delirium in Patients Undergoing Off-Pump Coronary Artery Bypass Grafting: A Randomized Controlled Trial

Effect of Perioperative re-Transcranial Electrical Stimulation on Postoperative Delirium in Patients Undergoing Off-Pump Coronary Artery Bypass Grafting: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105298
Enrollment
Unknown
Registered
2025-07-01
Start date
2025-07-14
Completion date
Unknown
Last updated
2025-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Delirium

Interventions

Active Group:In the afternoon of the first day before the operation, in the afternoon of the second day after the operation, in the afternoon of the third day after the operation, in the treatment roo
Hefei Brainqi Medical Technology Co., Ltd. Patients in the true tDCS group received 2 mA tDCS for 20 minutes, with a 30-second rising stage of current at the beginning and a 30-second falling stage at
but this did not happen.
Sham Group:Pseudo-tDCS were performed on patients in the treatment room of the ward on the afternoon of the first day before the operation, the afternoon of the second day after the operation, and the
Hefei Brainqi Medical Technology Co., Ltd. Patients in the pseudo-tDCS group only received a 30-second current rising stage and a 30-second falling stage at the beginning of each course of treatment,

Sponsors

The First Affiliated Hospital of Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Sign an informed consent form; 2.Coronary bypass transplantation is planned under general anesthesia; 3.Age>=18 years old; 4.Normal preoperative cognitive function (MoCA score >=24).

Exclusion criteria

Exclusion criteria: 1.Patients with a life expectancy of 6 months; 2.Have a history of mental illness or a history of nervous system diseases (including depression, severe central nervous system depression, schizophrenia, epilepsy, Parkinson's disease or Alzheimer's disease); 3.Major obstacles that may hinder cognitive testing, such as blindness, severe deafness or dementia; 4.Have used psychotropic drugs or opiate drugs, have a history of delirium before surgery; 5.Have a record of alcohol abuse or abstinence in the past 6 months; 6.Coma or dementia leads to inability to communicate effectively before surgery; 7.Participating in another clinical trial; 8.Body mass index (BMI)>=29kg/m^2 or<=18kg/m^2; 9.Plan to have another operation within 7 days after the first operation; 10.Patients with epilepsy or other abnormal EEG activity in the past; 11.Absolute contraindications for patients with tDCS include: implantable electronic devices (such as pacemakers, deep brain stimulators (LBS), vagus nerve stimulators (VNS), cochlear implants, programmable implantable pumps, and other electronic nerve regulation devices)intracranial metal implants, Uncontrolled epilepsy, severe skull defects, etc.

Design outcomes

Primary

MeasureTime frame
Incidence of delirium from the first day after surgery to the 7th day after surgery or before discharge from the hospital (whichever occurs first);

Secondary

MeasureTime frame
Cumulative incidence of POD;Incidence of severe delirium;Postoperative cognitive impairment on the 7th day after surgery or at the time of discharge (if earlier);Cognitive function one month after surgery;30-day all-cause mortality rate;The duration of the intensive care unit (the number of days in the intensive care unit from the end of the operation to the discharge) and the time of hospitalization after the operation;Time from the end of the operation to the appearance of delirium;Duration of delirium;The sum of the number of delirium-positive days in patients with delirium;Resting and exercise NRS score;Postoperative extubation time;Inflammatory factor level;Neurotrophic factor level;Re-admission to the intensive care unit within 30 days after the operation;Number of days to live within 30 days and be discharged from the hospital;

Countries

China

Contacts

Public ContactCheng Xinqi, Liu Xuesheng

The First Affiliated Hospital of Anhui Medical University

ay_mz_cheng@126.com+86 139 6501 5671

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026