Perioperative Neurocognitive DisorderNCT06488807
Treatment of Perioperative Neurocognitive Disorders With Olfactory Enrichment
A study testing Olfactory Enrichment in people with Perioperative Neurocognitive Disorder, run by Shanghai 10th People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Perioperative Neurocognitive Disorder
- What is being tested?
- Olfactory Enrichment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 686 participants
- Where
- 1 siteChina
- Study dates
- 7 Apr 2025to 31 Dec 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Tenth People's Hospital
Shanghai
Yuan Shen
About this study
Official title: Treatment of Perioperative Neurocognitive Disorders With Olfactory Enrichment: Study Protocol for a Randomized Controlled Trial
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.
Read the 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-PT217 level, and olfactory function.
- Conditions
- Perioperative Neurocognitive Disorder
- Being tested
- Olfactory Enrichment, Sham
- Keywords
- Perioperative Neurocognitive Disorder, Odor Enrichment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olfactory EnrichmentOther
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.
ShamOther
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 group | Role | What they receive |
|---|---|---|
| Olfactory Enrichment Group | Experimental | All participants enrolled in the olfactory enrichment group will receive twice sessions per day with an interval of at least 6 hours on preoperative day 1 and postoperative day 1-3. Each session will last 30 minutes. Each participant will be equipped with an electrical odor dispenser which allowed to distribute 8 odors (grapefruit, lavender, lemon, peppermint, tangerine, green tea, cloves and eucalyptus). When pushing a button, 4 odors will be released in turn and participants will sniff each odor (approximately 4 ml odorized air) for approximately 30 seconds by a nasal catheter. Considering of the adaption of odors, 4 odors will be used in the morning session and another 4 odors will be used in the afternoon session. Receives: Other: Olfactory Enrichment |
| Sham Group | Sham comparator | The sham group will receive sham olfactory enrichment sessions, which is designed with the same pattern (twice a day, 30 min for each session, on preoperative day 1 and on postoperative day 1-3. However, 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. Receives: Other: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative delirium
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.
Measured: at baseline and postoperative day 1 to 3
Secondary outcomes (1)
Incidence of delayed neurocognitive recovery and postoperative neurocognitive disorder
Participants' cognitive function will be assessed at baseline, on postoperative day 21, and at postoperative month 6 using a battery of neuropsychological tests, including the Montreal Cognitive Assessment (MoCA), Hopkins Verbal Learning Test Retention (HVLTRet), Hopkins Verbal Learning Test Total Recall (HVLTTR), Brief Visuospatial Memory Test Total Recall (BVMTTR), Brief Visuospatial Memory Test Delayed Recall (BVMTDR), Benton Judgment of Line Orientation (JLO), Digit Span Test (DST), Verbal Fluency Test (VFT) and Trail Making Test (TMT). Cognitive Change Index will be calculated by subtracting baseline scores from postoperative scores in each of the neuropsychological tests. Delayed neurocognitive recovery or postoperative neurocognitive disorder will be defined as by a decrease by one or more standard deviations in at least two of the neuropsychological tests from the baseline to 21 days or 6 months after anesthesia/surgery.
Measured: at baseline, on 21 days and 6 months after anesthesia/surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start7 Apr 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perioperative Neurocognitive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 686 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Responsible party
- Principal investigator, Yuan Shen, MD, PhD, Shanghai 10th People's Hospital
- Investigators
- Yuan Shen, Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06488807
- Sponsor's protocol ID
- dsyy008
- Status last verified
- May 2025
- First submitted
- 15 Jun 2024
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mei X, Wang J, Ni Z, Wang Y, Zhao B, Sessler DI, Xie Z, Shen Y. Effects of olfactory enrichment on perioperative neurocognitive disorders in elderly patients undergoing orthopedic surgery: a study protocol of a multi-center randomized controlled trial. Trials. 2025 Sep 26;26(1):363. doi: 10.1186/s13063-025-09109-w.
PubMed 41013688