Effect of Preoperative Olfactory Training on Postoperative Delirium in the Elderly Undergoing Orthopedic Surgeries

Postoperative Delirium Clinical Trial

Official title:

Preoperative Olfactory Training Reduces the Incidence of Postoperative Delirium in Elderly Patients Undergoingorthopedic Surgeries: a Prospective Randomized Controlled Clinical Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05908318
• Other study ID #: SYSKY-2023-137-02
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2023
• Est. completion date: January 2026

Study information

• Verified date: May 2023
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Yanni Fu
• Phone: 81332283
• Email: fuyanni[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 450
• Est. completion date: January 2026
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Emergence Delirium
• Postoperative Delirium

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of postoperative delirium	The 3D-CAM scores	Postoperative 1-5 days
Secondary	Degree of delirium	Memorial delirium assessment scale(MDSA)	Postoperative 1-5 days
Secondary	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.	postoperative 48h compared to preoperative 72h
Secondary	Cognitive function	Total score of the Montreal Cognitive Assessment (MoCA).	postoperative 5-7 days
Secondary	Postoperative pain	Post-operative pain, measured in visual analogue scale (VAS),0:no pian, 10:worst pain.	Postoperative 1-5 days
Secondary	Delirium related markers and inflammatory factors in bloods	These markers include:IL-6, IL-8, IL-10, TNF-a, IL-1ß, CRP, N-terminal BNP, albumin, NSE, S-100B, Aß-42 and T-tau, P-tau, S-100ß	immediate post-anesthesia compared to pre-operation
Secondary	Delirium related markers and inflammatory factors in cerebrospinal fluid	These markers include:IL-6, IL-8, IL-10, TNF-a, IL-1ß, albumin, NSE, S-100B, Aß-42 and T-tau, P-tau, S-100ß	immediate post-anesthesia compared to pre-operation