Status:
RECRUITING
Treatment of Perioperative Neurocognitive Disorders With Olfactory Enrichment
Lead Sponsor:
Shanghai 10th People's Hospital
Collaborating Sponsors:
National Natural Science Foundation of China
Conditions:
Perioperative Neurocognitive Disorder
Eligibility:
All Genders
65+ years
Phase:
NA
Brief Summary
Perioperative neurocognitive disorder (PND) is one of the most common postoperative complications among elderly patients. However, the mechanism and targeted intervention of PND remains unclear. Our p...
Detailed Description
The study will be a double-blinded, randomized controlled trial. Participants (65 years old or older) undergoing scheduled orthopaedic surgery (≥2 hours, under general anesthesia) will be randomized t...
Eligibility Criteria
Inclusion
- Age ≥65 years old.
- Having a scheduled surgery (≥2 hours, general anesthesia) (e.g., total hip replacement, toal knee replacement, open reduction and internal fixation of hip and lumbar spine).
- Being able to complete neuropsychological tests, 3D-CAM and CAM-S.
- Chinese Mandarin as their native language.
- Edmonton frailty scale (EFS) score ≥ 6.
Exclusion
- Having delirium, assessed by 3D-CAM, before surgery.
- Having a brain tumour, stroke or mental disorders (eg, major depressive disorder or dementia).
- Participating in other clinical studies at the time of screening.
- Unwillingness to comply with the protocol or procedures.
Key Trial Info
Start Date :
April 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
686 Patients enrolled
Trial Details
Trial ID
NCT06488807
Start Date
April 7 2025
End Date
December 31 2028
Last Update
May 14 2025
Active Locations (1)
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1
Shanghai Tenth People's Hospital
Shanghai, China