Using scent to prevent cognitive issues after surgery in older adults
Treatment of Perioperative Neurocognitive Disorders With Olfactory Enrichment: Study Protocol for a Randomized Controlled Trial
NA · Shanghai 10th People's Hospital · NCT06488807
This study tests if using pleasant scents can help older adults avoid memory and thinking problems after orthopedic surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 686 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Shanghai 10th People's Hospital (other) |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06488807 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates whether olfactory enrichment can prevent or treat perioperative neurocognitive disorder (PND) in elderly patients undergoing orthopedic surgery. Participants aged 65 and older will be randomly assigned to receive either olfactory enrichment or a sham treatment, with assessments conducted twice daily to evaluate the incidence and severity of postoperative delirium and cognitive function. The study aims to clarify the potential benefits of olfactory stimulation in mitigating cognitive decline associated with surgery.
Who should consider this trial
Good fit: Ideal candidates are elderly patients aged 65 and older scheduled for orthopedic surgery requiring general anesthesia.
Not a fit: Patients with pre-existing delirium, severe mental disorders, or those unable to comply with the study protocol may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of cognitive impairment in elderly patients after surgery.
How similar studies have performed: While olfactory enrichment has shown promise in animal studies, this clinical investigation is novel and has not been previously tested in humans for this specific application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥65 years old. 2. 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). 3. Being able to complete neuropsychological tests, 3D-CAM and CAM-S. 4. Chinese Mandarin as their native language. 5. Edmonton frailty scale (EFS) score ≥ 6. Exclusion Criteria: 1. Having delirium, assessed by 3D-CAM, before surgery. 2. Having a brain tumour, stroke or mental disorders (eg, major depressive disorder or dementia). 3. Participating in other clinical studies at the time of screening. 4. Unwillingness to comply with the protocol or procedures.
Where this trial is running
Shanghai
- Shanghai Tenth People's Hospital — Shanghai, China (RECRUITING)
Study contacts
- Principal investigator: Yuan Shen — Shanghai Mental Health Center
- Study coordinator: Yuan Shen
- Email: dr.yuanshen@foxmail.com
- Phone: +8618602169932
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Perioperative Neurocognitive Disorder, Odor Enrichment