About this trial
Neurocognitive complications, mainly delirium and neurocognitive disorders, are common cerebral complications in older patients after surgery and associated with worse outcomes. In previous studies, perioperative use of dexmedetomidine-esketamine combination improved analgesia and sleep quality after surgery. Perioperative use of transcranial direct current stimulation (tDCS) also improved sleep quality and reduced delirium occurrence early after surgery. This 2×2 factorial trial is designed to investigate the effects of perioperative dexmedetomidine-esketamine combination and tDCS on early postoperative neurocognitive recovery and delirium occurrence in older patients.
Eligibility criteria
Qualifiers
Aged 65 to 90 years;
Preoperative Mini-Mental State Examination (MMSE) score < 27 points, indicating possible cognitive impairment ranging from mild to moderate;
Scheduled to undergo elective non-cardiac, non-neurosurgical surgery under general anesthesia, with an expected surgical duration > 1 hour;
Required patient-controlled intravenous analgesia (PCIA) after surgery.
Disqualifiers
Preoperative inability to communicate due to coma, severe dementia, end-stage disease, or language impairment;
History of schizophrenia, epilepsy, Parkinson's disease, brain trauma/surgery, or myasthenia gravis;
Presence of metal implants in the intracranial or cervical region (such as cochlear implants, aneurysm clips, deep brain stimulation electrodes), or skin damage or severe skin disease on the head;
Severe cardiac dysfunction (left ventricular ejection fraction < 30%), comorbid with sick sinus syndrome, severe bradycardia (heart rate < 50 bpm), or second-degree or higher atrioventricular block, or implantation of a cardiac pacemaker;
Trial design
Treatments tested in this trial
- Dex-Esk
- Placebo
- Active tDCS
- Sham tDCS
Treatment groups
Sponsors and collaborators
Peking University First Hospital
Lead sponsor
Peking University Shenzhen Hospital
Collaborator
The First Affiliated Hospital of Air Force Medicial University
Collaborator
Zhejiang University
Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborator
Fujian Medical University Union Hospital
Collaborator