Postoperative delirium (following cardiovascular surgery)
Conditions
Interventions
Transcranial direct current stimulation administered postoperatively
Sponsors
Kawashima Hirotsugu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Undergoing open-heart surgery or surgery on major blood vessels - Aged 65 or older at the time consent is obtained
Exclusion criteria
Exclusion criteria: - Emergency Surgery - Patients classified as Class V on the American Society of Anesthesiologists Physical Status (ASA-PS) scale - Patients already exhibiting delirium at the time of obtaining informed consent - Patients requiring infection control measures - Patients with a possible pregnancy - Patients with epilepsy or a history thereof, a history of severe head trauma (within the past 2 years), severe mental illness, or alcohol/substance abuse (within the past 1 year) - Patients with implantable devices such as pacemakers, intracranial metal, or other metallic implants - Patients for whom electrode placement is hindered by scalp skin conditions or other factors - Patients unable to communicate sufficiently in Japanese - Cases where the estimated completion time of surgery exceeds 6:00 PM - Other study participants deemed unsuitable for the safe conduct of this study by the principal investigator or co-investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of delirium diagnosed by DSM-5-TR within 4 postoperative days | — |
Secondary
| Measure | Time frame |
|---|---|
| - Feasibility (consent rate, recruitment rate, protocol compliance rate, dropout rate, data collection completeness) - Safety assessment (adverse events, vital signs, ECG, skin findings) - Delirium subtypes and duration -Diagnosis and severity of delirium using various delirium assessment scales (DRS-R-98, CAM-ICU, ICDSC) - Quantitative EEG indices - Pain (NRS, CPOT-J) - Inflammation and stress markers - Changes in cognitive function (MoCA-J at 12 weeks post-surgery) - Clinical outcomes (ICU and hospital length of stay, mortality, discharge destination) | — |
Contacts
Public ContactHirotsugu Kawashima
Kyoto University Hospital
Outcome results
None listed