Postoperative delirium
Conditions
Interventions
A Group:Intraoperative continuous infusion of dexmedetomidine, followed by a single session of real transcranial direct current stimulation (tDCS) within 30 minutes after extubation.
B Group:Intraoperative continuous intravenous infusion of dexmedetomidine, followed by a single session of sham transcranial direct current stimulation (tDCS) during the postoperative emergence period
C Group:Intraoperative continuous infusion of 0.9% sodium chloride injection (placebo), followed by a single session of real transcranial direct current stimulation (tDCS) within 30 minutes after extu
D Group:Intraoperative continuous infusion of 0.9% sodium chloride injection (placebo), followed by a single session of sham transcranial direct current stimulation (tDCS) during the postoperative eme
Sponsors
The first affiliated hospital of anhui medical university
Eligibility
Sex/Gender
All
Age
65 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1.Provision of written informed consent; 2.Scheduled to undergo elective major non-cardiac, non-neurosurgical surgery under general anesthesia; 3.Age >= 65 years and = 24;
Exclusion criteria
Exclusion criteria: 1.Anticipated life expectancy of less than 6 months; 2.Pre-existing history of psychiatric or neurological disorders, including but not limited to major depressive disorder, severe central nervous system depression, schizophrenia, epilepsy, Parkinson's disease, or Alzheimer's disease; 3.Significant impairment precluding cognitive assessment, such as blindness, severe hearing loss, or pre-existing dementia; 4.Prior use of psychotropic medications or opioids, or a documented history of preoperative delirium; 5.Record of alcohol abuse or alcohol withdrawal within the preceding 6 months; 6.Preoperative inability to communicate effectively due to coma or severe dementia; 7.Concurrent participation in another interventional clinical trial; 8.Severe sinus bradycardia or any contraindication to the administration of dexmedetomidine; 9.Body mass index (BMI) >= 29 kg/m^2 or <= 18 kg/m^2; 10.Planned reoperation within 7 days following the index procedure; 11.History of epilepsy or other disorders characterized by abnormal electroencephalographic activity; 12.Presence of absolute contraindications to transcranial direct current stimulation (tDCS), including: implanted electronic devices (e.g., cardiac pacemaker, deep brain stimulator, vagus nerve stimulator, cochlear implant, programmable infusion pump, or other electronic neurostimulation devices); intracranial metallic implants; uncontrolled epilepsy; or significant cranial bone defects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of delirium from postoperative day 1 through postoperative day 7 or until hospital discharge, whichever occurred first.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Numeric Rating Scale (NRS) pain scores at rest and during movement at 6, 12, 24, 48, and 72 hours postoperatively.;Length of intensive care unit (ICU) stay, defined as the total number of days spent in the ICU from the completion of surgery until hospital discharge.;Duration of delirium, defined as the interval from the first day a positive delirium assessment was recorded to the last day of documented delirium, regardless of the presence of intervening delirium-;Brain-derived neurotrophic factor (BDNF) levels on postoperative days 1, 3, 5, and 7.;Time from completion of surgery to onset of delirium.;Cognitive function at one month postoperatively, assessed using the Telephone Interview for Cognitive Status–modified (TICS-m; score range: 0 [worst] to 50 [best]).;Days alive and out of hospital within 30 days postoperatively (DAOH-30). DAOH-30 was defined as the total number of days a patient was both alive and not hospitalized during the first 30 days followin;Total number of delirium-positive days among patients who developed postoperative delirium.;Time to extubation, defined as the interval from the completion of surgery to tracheal extubation.;Inflammatory cytokine levels on postoperative days 1, 3, 5, and 7.;Cumulative incidence of postoperative delirium.;Readmission to the intensive care unit within 30 days postoperatively.;Postoperative cognitive dysfunction (POCD) at postoperative day 7 or at hospital discharge, whichever occurred earlier, assessed using the Montreal Cognitive Assessment (MoCA; score range: 0 [worst] t;30-day all-cause mortality;Incidence of severe delirium, as assessed by the Delirium Rating Scale-Revised-98 (DRS-R-98).; | — |
Countries
China
Contacts
Public ContactShen Qiyin
The first affiliated hospital of anhui medical university
Outcome results
None listed