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

NCT05908318 | Unknown

• 1 other identifier: SYSKY-2023-137-02
• Study Type: interventional
• Target: 450
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Preoperative Olfactory Training; Postoperative Delirium

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative delirium

  The 3D-CAM scores

  Postoperative 1-5 days

Secondary Outcomes (6)

• Degree of delirium

  Postoperative 1-5 days

• Olfactory function

  postoperative 48h compared to preoperative 72h

• Cognitive function

  postoperative 5-7 days

• Postoperative pain

  Postoperative 1-5 days

• Delirium related markers and inflammatory factors in bloods

  immediate post-anesthesia compared to pre-operation

Study Arms (2)

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.

Behavioral: olfactory training

Interventions

olfactory training BEHAVIORAL

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.

olfactory training group

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

MeSH Terms

Conditions

Emergence Delirium

Interventions

Olfactory Training

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Yanni Fu

CONTACT

81332283; fuyanni@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: In this study, different researchers will be responsible for randomization, olfactory training, anesthesia and visit. Due to the peroperative olfactory training in the olfactory training group, it is impossible to blind the participant and researchers implementing olfactory training.A researcher is responsible for assigning random numbers to ensure the randomness of the study groups. In order to ensure that the whole study is not affected by subjective factors, the researchers implementing and visiting are blinded, who do not know the anesthesia grouping, and are responsible for anesthsia, case enrollment screening, signing informed consent, preoperative and postoperative delirium evaluation, postoperative pain evaluation, complications and safety evaluation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 29, 2023
• First Posted: June 18, 2023
• Study Start: July 1, 2023
• Primary Completion: July 1, 2025
• Study Completion: January 1, 2026
• Last Updated: June 18, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share