Dexmedetomidine-esketamine and tDCS for Prevention of Neurocognitive Complications After Surgery

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age65-90
SponsorPeking University First Hospital

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

1,160 Participants
are divided into 4 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