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

Primary Purpose

Preoperative Olfactory Training, Postoperative Delirium

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
olfactory training
Sponsored by
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preoperative Olfactory Training

Eligibility Criteria

60 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control group

    olfactory training group

    Arm Description

    The control group conducts standard preoperative preparation

    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.

    Outcomes

    Primary Outcome Measures

    Incidence of postoperative delirium
    The 3D-CAM scores

    Secondary Outcome Measures

    Degree of delirium
    Memorial delirium assessment scale(MDSA)
    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.
    Cognitive function
    Total score of the Montreal Cognitive Assessment (MoCA).
    Postoperative pain
    Post-operative pain, measured in visual analogue scale (VAS),0:no pian, 10:worst pain.
    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
    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

    Full Information

    First Posted
    May 29, 2023
    Last Updated
    June 8, 2023
    Sponsor
    Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05908318
    Brief Title
    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

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 2023 (Anticipated)
    Primary Completion Date
    July 2025 (Anticipated)
    Study Completion Date
    January 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Preoperative Olfactory Training, Postoperative Delirium

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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
    Outcomes Assessor
    Masking Description
    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.
    Allocation
    Randomized
    Enrollment
    450 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    The control group conducts standard preoperative preparation
    Arm Title
    olfactory training group
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    olfactory training
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Incidence of postoperative delirium
    Description
    The 3D-CAM scores
    Time Frame
    Postoperative 1-5 days
    Secondary Outcome Measure Information:
    Title
    Degree of delirium
    Description
    Memorial delirium assessment scale(MDSA)
    Time Frame
    Postoperative 1-5 days
    Title
    Olfactory function
    Description
    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.
    Time Frame
    postoperative 48h compared to preoperative 72h
    Title
    Cognitive function
    Description
    Total score of the Montreal Cognitive Assessment (MoCA).
    Time Frame
    postoperative 5-7 days
    Title
    Postoperative pain
    Description
    Post-operative pain, measured in visual analogue scale (VAS),0:no pian, 10:worst pain.
    Time Frame
    Postoperative 1-5 days
    Title
    Delirium related markers and inflammatory factors in bloods
    Description
    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
    Time Frame
    immediate post-anesthesia compared to pre-operation
    Title
    Delirium related markers and inflammatory factors in cerebrospinal fluid
    Description
    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
    Time Frame
    immediate post-anesthesia compared to pre-operation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yanni Fu
    Phone
    81332283
    Email
    fuyanni@126.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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