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Clinical Trials in China / NCT06488807
Recruiting Not applicable

Treatment of Perioperative Neurocognitive Disorders With Olfactory Enrichment

NCT06488807 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai 10th People's Hospital
Phase
Not applicable
Started
2025-04-07
Last updated
2025-05-14

Condition(s) studied

Perioperative Neurocognitive Disorder

Investigational drug(s) / intervention(s)

Olfactory EnrichmentSham

Olfactory Enrichment: Each participant will be equipped with an electrical odor dispenser which allowed to distribute 8 odors (grapefruit, lavender, lemon, peppermint, menthol, tangerine, green tea, and bergamot). The choice of odors was guided by (1) pleasantness of the odors, (2) presence of slight trigeminal activation in some of the odors, e.g., peppermint, (3) evaporation characteristics, so that the odors would last for the duration of the experiment, (4) technical issues mostly in terms of compatibility with the odor cartridge, (5) availability, and (6) inspiration from the previous studies.

Sham: The containers provided to the sham group will be odorless. The odor containers and labels will appear identical to those used in the olfactory enrichment group.

Study 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 previous clinical studies demonstrated the association between olfactory impairment and PND. Moreover, our translational studies showed that anesthesia/surgery induced olfactory impairment and caused cognitive impairment in mice and olfactory enrichment could prevent the anesthesia/surgery-induced cognitive impairment. However, there was no clinical investigation to determine whether olfactory enrichment can mitigate PND in elderly patients. Therefore, we propose determining whether olfactory enrichment can prevent and/or treat PND in elderly patients.

Eligibility

Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Incidence of postoperative delirium — at baseline and postoperative day 1 to 3
    The presence of postoperative delirium will be defined according to 3D-CAM, which includes four entries: acute onset and fluctuating course, inattention, disorganized thinking and altered level of consciousness. To diagnose delirium, both the first and second criteria have to be present plus the third and/or fourth criteria. Every participant will be assessed twice daily after anesthesia/surgery from postoperative day 1 to postoperative day 3, with the first assessment between 8:00 and 10:00. The second assessment will be between 15:00 and 17:00.

Trial sites (1)

FacilityCityRegionStatus
Shanghai Tenth People's Hospital Shanghai China Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06488807 on ClinicalTrials.gov ↗ ← All trials in China