Dexmedetomidine-esketamine and tDCS for Prevention of Neurocognitive Complications After Surgery
Starting soon · Phase 4 · Has a placebo group
Conditions studied: Older Patients, Surgery, Dexmedetomidine, Esketamine, Transcranial Direct Current Stimulation, Perioperative Neurocognitive Disorders
In brief
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.
Key facts
- Study ID
- NCT07576517
- Run by
- Peking University First Hospital
- People needed
- 1160
- Starts
- 2026-06-01
- Expected to finish
- 2030-06-01
- Last updated by the study team
- 2026-05-12
Who can join
Age: 65 and older, up to 90. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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;
- Uncontrolled hyperthyroidism or pheochromocytoma;
- Severe liver dysfunction (Child-Pugh class C), severe renal dysfunction (requiring dialysis), or ASA classification ≥ IV;
- Allergy to dexmedetomidine or esketamine;
- Participation in other clinical studies within the past 3 months;
- Other conditions that are deemed unsuitable for study participation.
Where it is running
- Peking University First Hospital — Beijing, Beijing Municipality, China
- Fujian Medical University Union Hospital — Fuzhou, Fujian, China
- Peking University Shenzhen Hospital — Shenzhen, Guangdong, China
- Xijing Hospital, Air Force Medical University — Xi'an, Shaanxi, China
- First Affilited Hospital, School of Medicine, Zhejiang University — Hangzhou, Zhejiang, China
- Second Affilited Hospital, School of Medicine, Zhejiang University — Hangzhou, Zhejiang, China
Full record on ClinicalTrials.gov
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