Preoperative Olfactory TrainingNCT05908318
Effect of Preoperative Olfactory Training on Postoperative Delirium in the Elderly Undergoing Orthopedic Surgeries
A study testing olfactory training in people with Preoperative Olfactory Training and Postoperative Delirium, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
Trial summary
To observe whether preoperative olfactory training can reduces the incidence of postoperative delirium in elderly patients undergoing orthopedic surgeries, a prospective randomized controlled study method will be used in this study. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Preoperative Olfactory Training, Postoperative Delirium
- What is being tested?
- olfactory training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- No sites listed yet
- Study dates
- Jul 2023to Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoingorthopedic surgeries (hip or knee replacement and laminectomy) under general anesthesia or combined spinal-epidural anesthesia:
- 65 years old ≤ age ≤ 90 years old, gender is not limited, ASA classification ≤ class III:
- There is no recent history of surgery, and the operation time is ≥ 2 hours.
- Able to communicate normally, able to cooperate and complete the cognitive function test. MMSE score >17.
- Patients and their families are aware of and willing to participate.
Who cannot join
- emergency surgery;
- People with brain diseases or history of brain diseases such as cerebral infarction, stroke, etc.:
- Have a history of neurological and psychological diseases, including Alzheimer's disease, Parkinson's, psychosis, etc.:
- Illiteracy, severe hearing or visual impairment;
- Those who have taken psychotropic drugs or abused psychotropic drugs within one month:
- Sinusitis, previous nasal surgery history, nasal congestion, upper respiratory tract infection in the past two weeks, previously diagnosed rhinitis and other diseases that may affect olfactory function.
- Patients who are allergic to pollen
- Patients who cannot cooperate or refuse to sign informed consent
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Preoperative Olfactory Training Reduces the Incidence of Postoperative Delirium in Elderly Patients Undergoingorthopedic Surgeries: a Prospective Randomized Controlled Clinical Study
To observe whether preoperative olfactory training can reduces the incidence of postoperative delirium in elderly patients undergoing orthopedic surgeries, a prospective randomized controlled study method will be used in this study.
Read the detailed description
450 elderly patients undergoing orthopedic surgeries (hip or knee replacement and laminectomy) under general anesthesia or combined spinal epidural anesthesia will be selected. They will be randomly divided into control group and olfactory training group.The olfactory training group was performed 24-48h before surgery used phenylethyl alcohol (rose), phytol (press tree), citronella (lemon), eugenol (clove) 4 kinds of smell，twice a day for three days. The general condition, operation, anesthesia and hospitalization related data of the patients will be recorded.
Outcome Measures： Incidence of postoperative delirium: The 3D-CAM scores of the control group and the olfactory training group were evaluated within 1-5 days after operation.
Degree of delirium：The MDAS of the control group and the olfactory training group were evaluated within 1-5 days after operation.
Pain：The VAS of the control group and the olfactory training group were evaluated within 1-5 days after operation.
Olfactory function：The TDI scores of the control group and the olfactory training group were evaluated in 3 days before operation and 48h after operation.
Cognitive function：The MoCA scores of the control group and the olfactory training group were evaluated in postoperative 5-7 days.
Markers: Delirium related markers and inflammatory factors in bloods was detected before surgery and after anesthesia. Delirium related markers and inflammatory factors in cerebrospinal fluid was detected after spinal puncture.
Subgroup analysis: patients were divided into delirium group and non-delirium group according to whether delirium occurred, and the data of the two groups were compared, including preoperative and postoperative olfactory function TDI scores, preoperative and postoperative VAS scores, nutritional scores, activity scores, and frailty index, Carlson comorbidity index, depression, anxiety state, sleep disturbance, etc., to screen risk factors.
- Being tested
- olfactory training
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olfactory trainingBehavioural
In this group, patients were performed 24-48h before surgery used phenylethyl alcohol (rose), phytol (press tree), citronella (lemon), eugenol (clove) 4 kinds of smell，twice a day for three days.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | The control group conducts standard preoperative preparation |
| olfactory training group | Experimental | The olfactory training group was performed 24-48h before surgery used phenylethyl alcohol (rose), phytol (press tree), citronella (lemon), eugenol (clove) 4 kinds of smell，twice a day for three days. Receives: Behavioral: olfactory training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative delirium
The 3D-CAM scores
Measured: Postoperative 1-5 days
Secondary outcomes (6)
Degree of delirium
Memorial delirium assessment scale(MDSA)
Measured: Postoperative 1-5 days
Olfactory function
The Sniffin' Sticks test involves testing odor for threshold and discrimination whilst blind folded and secondly odor identification. The sum of four odors responses ranges from 0-16. The sum of total score from odor Threshold, Discrimination and Identification (TDI) is a maximum of 48 points. The total score is graded as; normosmia equals or over 30.5 points, hyposmia 16.5-30 points and anosmia less than 16.5 points.
Measured: postoperative 48h compared to preoperative 72h
Cognitive function
Total score of the Montreal Cognitive Assessment (MoCA).
Measured: postoperative 5-7 days
Postoperative pain
Post-operative pain, measured in visual analogue scale (VAS),0:no pian, 10:worst pain.
Measured: Postoperative 1-5 days
Delirium related markers and inflammatory factors in bloods
These markers include:IL-6, IL-8, IL-10, TNF-α, IL-1β, CRP, N-terminal BNP, albumin, NSE, S-100B, Aβ-42 and T-tau, P-tau, S-100β
Measured: immediate post-anesthesia compared to pre-operation
Delirium related markers and inflammatory factors in cerebrospinal fluid
These markers include:IL-6, IL-8, IL-10, TNF-α, IL-1β, albumin, NSE, S-100B, Aβ-42 and T-tau, P-tau, S-100β
Measured: immediate post-anesthesia compared to pre-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study startJul 2023 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative Olfactory TrainingStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Recruited patients will be randomly divided into control group and olfactory training group.The olfactory training group was performed 24-48h before surgery used phenylethyl alcohol (rose), phytol (press tree), citronella (lemon), eugenol (clove) 4 kinds of smell，twice a day for three days.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05908318
- Sponsor's protocol ID
- SYSKY-2023-137-02
- Status last verified
- May 2023
- First submitted
- 29 May 2023
- Last updated
- 18 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Olfactory Training Reduces the Incidence of Postoperative Delirium in Elderly Patients Undergoingorthopedic Surgeries: a Prospective Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT05908318
- Acronym / sponsor ID
- SYSKY-2023-137-02
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- Jul 2023 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To observe whether preoperative olfactory training can reduces the incidence of postoperative delirium in elderly patients undergoing orthopedic surgeries, a prospective randomized controlled study method will be used in this study.
Detailed description
450 elderly patients undergoing orthopedic surgeries (hip or knee replacement and laminectomy) under general anesthesia or combined spinal epidural anesthesia will be selected. They will be randomly divided into control group and olfactory training group.The olfactory training group was performed 24-48h before surgery used phenylethyl alcohol (rose), phytol (press tree), citronella (lemon), eugenol (clove) 4 kinds of smell，twice a day for three days. The general condition, operation, anesthesia and hospitalization related data of the patients will be recorded.
Outcome Measures： Incidence of postoperative delirium: The 3D-CAM scores of the control group and the olfactory training group were evaluated within 1-5 days after operation.
Degree of delirium：The MDAS of the control group and the olfactory training group were evaluated within 1-5 days after operation.
Pain：The VAS of the control group and the olfactory training group were evaluated within 1-5 days after operation.
Olfactory function：The TDI scores of the control group and the olfactory training group were evaluated in 3 days before operation and 48h after operation.
Cognitive function：The MoCA scores of the control group and the olfactory training group were evaluated in postoperative 5-7 days.
Markers: Delirium related markers and inflammatory factors in bloods was detected before surgery and after anesthesia. Delirium related markers and inflammatory factors in cerebrospinal fluid was detected after spinal puncture.
Subgroup analysis: patients were divided into delirium group and non-delirium group according to whether delirium occurred, and the data of the two groups were compared, including preoperative and postoperative olfactory function TDI scores, preoperative and postoperative VAS scores, nutritional scores, activity scores, and frailty index, Carlson comorbidity index, depression, anxiety state, sleep disturbance, etc., to screen risk factors.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Recruited patients will be randomly divided into control group and olfactory training group.The olfactory training group was performed 24-48h before surgery used phenylethyl alcohol (rose), phytol (press tree), citronella (lemon), eugenol (clove) 4 kinds of smell，twice a day for three days.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The control group conducts standard preoperative preparation |
| olfactory training group | Experimental | Behavioral: olfactory trainingThe olfactory training group was performed 24-48h before surgery used phenylethyl alcohol (rose), phytol (press tree), citronella (lemon), eugenol (clove) 4 kinds of smell，twice a day for three days. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients undergoingorthopedic surgeries (hip or knee replacement and laminectomy) under general anesthesia or combined spinal-epidural anesthesia:
- 65 years old ≤ age ≤ 90 years old, gender is not limited, ASA classification ≤ class III:
- There is no recent history of surgery, and the operation time is ≥ 2 hours.
- Able to communicate normally, able to cooperate and complete the cognitive function test. MMSE score >17.
- Patients and their families are aware of and willing to participate.
Key exclusion criteria (8 listed)
- emergency surgery;
- People with brain diseases or history of brain diseases such as cerebral infarction, stroke, etc.:
- Have a history of neurological and psychological diseases, including Alzheimer's disease, Parkinson's, psychosis, etc.:
- Illiteracy, severe hearing or visual impairment;
- Those who have taken psychotropic drugs or abused psychotropic drugs within one month:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| olfactory trainingIn this group, patients were performed 24-48h before surgery used phenylethyl alcohol (rose), phytol (press tree), citronella (lemon), eugenol (clove) 4 kinds of smell，twice a day for three days. | Behavioural | olfactory training group |
Primary outcome
Incidence of postoperative delirium
Time frame: Postoperative 1-5 days
The 3D-CAM scores
6 secondary outcomes
Degree of delirium
Time frame: Postoperative 1-5 days
Olfactory function
Time frame: postoperative 48h compared to preoperative 72h
Cognitive function
Time frame: postoperative 5-7 days
Postoperative pain
Time frame: Postoperative 1-5 days
Delirium related markers and inflammatory factors in bloods
Time frame: immediate post-anesthesia compared to pre-operation
Delirium related markers and inflammatory factors in cerebrospinal fluid
Time frame: immediate post-anesthesia compared to pre-operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing olfactory training in people with Preoperative Olfactory Training and Postoperative Delirium, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanni Fu (81332283, fuyanni@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative delirium (time frame: Postoperative 1-5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.