Effect of Preoperative Olfactory Training on Postoperative Delirium in the Elderly Undergoing Orthopedic Surgeries
NCT ID: NCT05908318
Last Updated: 2023-06-18
Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
450 participants
INTERVENTIONAL
2023-07-31
2026-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Control group
The control group conducts standard preoperative preparation
No interventions assigned to this group
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.
olfactory training
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.
Interventions
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olfactory training
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.
Eligibility Criteria
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Inclusion Criteria
2. 65 years old ≤ age ≤ 90 years old, gender is not limited, ASA classification ≤ class III:
3. There is no recent history of surgery, and the operation time is ≥ 2 hours.
4. Able to communicate normally, able to cooperate and complete the cognitive function test. MMSE score \>17.
5. Patients and their families are aware of and willing to participate.
Exclusion Criteria
2. People with brain diseases or history of brain diseases such as cerebral infarction, stroke, etc.:
3. Have a history of neurological and psychological diseases, including Alzheimer's disease, Parkinson's, psychosis, etc.:
4. Illiteracy, severe hearing or visual impairment;
5. Those who have taken psychotropic drugs or abused psychotropic drugs within one month:
6. 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.
7. Patients who are allergic to pollen
8. Patients who cannot cooperate or refuse to sign informed consent
60 Years
90 Years
ALL
No
Sponsors
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Responsible Party
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Central Contacts
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Other Identifiers
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SYSKY-2023-137-02
Identifier Type: -
Identifier Source: org_study_id
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