Ignite Creation Date:
2024-07-17 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06488807
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-15
Brief Title:
Treatment of Perioperative Neurocognitive Disorders With Olfactory Enrichment
Sponsor:
Shanghai 10th Peoples Hospital
Organization:
Shanghai 10th Peoples Hospital
Study Overview
Official Title:
Treatment of Perioperative Neurocognitive Disorders With Olfactory Enrichment Study Protocol for a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 previous clinical studies demonstrated the association between olfactory impairment and PND Moreover our translational studies showed that anesthesiasurgery induced olfactory impairment and caused cognitive impairment in mice and olfactory enrichment could prevent the anesthesiasurgery-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 andor treat PND in elderly patients
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 to either olfactory enrichment group or sham group Participants in olfactory enrichment group will receive olfactory enrichment with a dispenser twice sessions per day on preoperative day 1-3 and postoperative day 1-3 30 min per session 4 odors for each session while participants in sham group will be equipped with the same pattern except that water will be used in the dispenser Participants will be assessed twice daily by a research assistant blinded to allocation The primary outcome will be the incidence of postoperative delirium measured by the Confusion Assessment Method on postoperative days 1 2 and 3 The secondary outcomes will be the severity of postoperative delirium cognitive function plasma Tau level including Tau-PT217 and Tau-PT181 levels and olfactory function
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None