Status:
NOT_YET_RECRUITING
Prospective Randomized Controlled Trial of VR Cognitive Training in Reducing Postoperative Delirium in Elderly Patients With Cerebral Small Vessel Disease Undergoing Non-Cardiac Surgery
Lead Sponsor:
Peking University Third Hospital
Collaborating Sponsors:
Peking University First Hospital
Conditions:
Postoperative Delirium (POD)
Cerebral Small Vessel Diseases
Eligibility:
All Genders
65+ years
Phase:
NA
Brief Summary
This clinical study investigates whether virtual reality (VR)-based cognitive training can help prevent postoperative delirium (POD) in elderly non-cardiac patients with pre-existing cerebral small ve...
Eligibility Criteria
Inclusion
- Age ≥ 65 years; Preoperative MRI diagnosis of cerebral small vessel disease (CSVD); Scheduled to undergo non-cardiac, non-intracranial procedures under general anesthesia; Expected surgery duration \> 2 hours; ASA physical status classification: I-III; No use of cognitive-enhancing medications within 3 months prior to surgery; Willing to participate and provide written informed consent.
Exclusion
- Contraindications to cranial MRI (e.g., cardiac pacemaker, metallic implants, etc.); Patients experiencing subjective discomfort (dizziness, nausea, vomiting) during VR device adaptation; Severe visual or auditory impairment; Severe hepatic or renal dysfunction; Pre-existing neuropsychiatric disorders (schizophrenia, epilepsy, Parkinson's disease, delirium, etc.); Inability to complete preoperative neuropsychological assessments (dementia, deaf-mutism, communication disorders); History of cerebrovascular events (stroke, transient ischemic attack, etc.) within 3 months prior to surgery; Current use of sedatives/antidepressants or history of psychoactive substance abuse/alcoholism.
Key Trial Info
Start Date :
May 31 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
416 Patients enrolled
Trial Details
Trial ID
NCT06999668
Start Date
May 31 2025
End Date
December 31 2027
Last Update
May 31 2025
Active Locations (2)
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1
Peking university first hospital
Beijing, Beijing Municipality, China
2
Peking university third hospital
Beijing, Beijing Municipality, China