Clinical trial NCT05908318: Effect of Preoperative Olfactory Training on Postoperative Delirium in the Elderly Undergoing Orthopedic Surgeries
Official title: Preoperative Olfactory Training Reduces the Incidence of Postoperative Delirium in Elderly Patients Undergoingorthopedic Surgeries: a Prospective Randomized Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Preoperative Olfactory Training
Postoperative Delirium
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 450
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Patients undergoingorthopedic surgeries (hip or knee replacement and laminectomy) under general anesthesia or combined spinal-epidural anesthesia:
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:

1. emergency surgery;
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

Primary outcomes:
measure: Incidence of postoperative delirium
timeFrame: Postoperative 1-5 days
Secondary outcomes:
measure: Degree of delirium
timeFrame: Postoperative 1-5 days
measure: Olfactory function
timeFrame: postoperative 48h compared to preoperative 72h
measure: Cognitive function
timeFrame: postoperative 5-7 days
measure: Postoperative pain
timeFrame: Postoperative 1-5 days
measure: Delirium related markers and inflammatory factors in bloods
timeFrame: immediate post-anesthesia compared to pre-operation
measure: Delirium related markers and inflammatory factors in cerebrospinal fluid
timeFrame: immediate post-anesthesia compared to pre-operation
Other outcomes:
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