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Olfactory Function and Postoperative Cognitive Dysfunction

Primary Purpose

Postoperative Cognitive Dysfunction

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
enhanced olfactory stimuli
Sponsored by
Shanghai 10th People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Cognitive Dysfunction

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Keen surgery under general anesthesia;
  2. Age is greater than or equal to 65 years old;
  3. Han Nationality, mother tongue is chinese;
  4. The MMSE score: Illiteracy is greater than or equal to 17 points, primary school is greater than or equal to 20 points, higher secondary school is more than 24 points;
  5. Being able to complete the assessments without serious visual or hearing difficulty;
  6. Without serious heart, brain, liver, kidney, lung and other organs;
  7. Without serious neurological and psychiatric disorders, such as Alzheimer's disease, Parkinson's syndrome, multiple sclerosis, schizophrenia, depression, etc.;
  8. The ASA class I or II;
  9. The people signed informed consent.

Exclusion Criteria:

  1. Had severe head and face disease, trauma history or history of surgery;
  2. Had a history of influenza in 3 weeks;
  3. The serious body disease and tobacco, wine and other substance abuse history;
  4. The presence of malignant tumor with shorter survival disease.

Sites / Locations

  • Shanghai Tenth People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Non-intervention Group

Arm Description

Patients randomly assigned to intervention group will get enhanced olfactory stimuli during the perioperative period

Patients randomly assigned to non-intervention group will not get any olfactory stimuli during the perioperative period

Outcomes

Primary Outcome Measures

Change of cognitive function
The neuropsychological tests to assess change of cognitive function between baseline and follow-up

Secondary Outcome Measures

Change of olfactory function
The olfactory tests to assess change of olfactory function between baseline and follow-up

Full Information

First Posted
February 15, 2018
Last Updated
March 19, 2021
Sponsor
Shanghai 10th People's Hospital
Collaborators
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03441074
Brief Title
Olfactory Function and Postoperative Cognitive Dysfunction
Official Title
Effects of Enriched Olfactory Stimuli on Postoperative Cognitive Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai 10th People's Hospital
Collaborators
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To study the correlation of POCD with olfactory function. To explore whether enhanced olfactory stimuli can reduce the risk of POCD as a preventive strategy.
Detailed Description
Postoperative cognitive dysfunction (POCD), the most common complications of geriatric surgical patients, could contribute to long-term social dysfunction, high mortality and increased medical cost. Previous studies have suggested that impaired Olfaction was related to postoperative delirium (Nadya M. Dhanani et al, J Clin Anesth 2012; Charles H. Brown IV et al, J Am Geriatr So 2015; Min Seung Kim et al, J Neural Transm 2016). However, there is still no efficient treatment for POCD, and it also remains largely unknown whether enhanced olfactory stimuli can be used as an inventive strategy to reduce the risk of POCD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Cognitive Dysfunction

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Patients randomly assigned to intervention group will get enhanced olfactory stimuli during the perioperative period
Arm Title
Non-intervention Group
Arm Type
No Intervention
Arm Description
Patients randomly assigned to non-intervention group will not get any olfactory stimuli during the perioperative period
Intervention Type
Behavioral
Intervention Name(s)
enhanced olfactory stimuli
Intervention Description
Patients in intervention group will get enhanced olfactory stimuli during perioperative period (7 days before and after the surgery), by using portable scented sachets.
Primary Outcome Measure Information:
Title
Change of cognitive function
Description
The neuropsychological tests to assess change of cognitive function between baseline and follow-up
Time Frame
1 day before surgery (baseline) and 7 days after surgery (follow-up)
Secondary Outcome Measure Information:
Title
Change of olfactory function
Description
The olfactory tests to assess change of olfactory function between baseline and follow-up
Time Frame
1 day before surgery (baseline) and 7 days after surgery (follow-up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Keen surgery under general anesthesia; Age is greater than or equal to 65 years old; Han Nationality, mother tongue is chinese; The MMSE score: Illiteracy is greater than or equal to 17 points, primary school is greater than or equal to 20 points, higher secondary school is more than 24 points; Being able to complete the assessments without serious visual or hearing difficulty; Without serious heart, brain, liver, kidney, lung and other organs; Without serious neurological and psychiatric disorders, such as Alzheimer's disease, Parkinson's syndrome, multiple sclerosis, schizophrenia, depression, etc.; The ASA class I or II; The people signed informed consent. Exclusion Criteria: Had severe head and face disease, trauma history or history of surgery; Had a history of influenza in 3 weeks; The serious body disease and tobacco, wine and other substance abuse history; The presence of malignant tumor with shorter survival disease.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuan Shen, MD, PhD
Phone
2166303649
Email
kmshy@tongji.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Zhongyong Shi, MD
Phone
18701915271
Email
szy0721@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuan Shen
Organizational Affiliation
Shanghai 10th People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Tenth People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200072
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanxia Guo, M.D.
Phone
021-65982875
Email
guoyx_2000@tongji.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27098668
Citation
Kim MS, Yoon JH, Kim HJ, Yong SW, Hong JM. Olfactory dysfunction is related to postoperative delirium in Parkinson's disease. J Neural Transm (Vienna). 2016 Jun;123(6):589-94. doi: 10.1007/s00702-016-1555-0. Epub 2016 Apr 20.
Results Reference
result
PubMed Identifier
25597555
Citation
Brown CH 4th, Morrissey C, Ono M, Yenokyan G, Selnes OA, Walston J, Max L, LaFlam A, Neufeld K, Gottesman RF, Hogue CW. Impaired olfaction and risk of delirium or cognitive decline after cardiac surgery. J Am Geriatr Soc. 2015 Jan;63(1):16-23. doi: 10.1111/jgs.13198.
Results Reference
result
PubMed Identifier
22495083
Citation
Dhanani NM, Jiang Y. Anosmia and hypogeusia as a complication of general anesthesia. J Clin Anesth. 2012 May;24(3):231-3. doi: 10.1016/j.jclinane.2011.08.005. Epub 2012 Apr 9.
Results Reference
result

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Olfactory Function and Postoperative Cognitive Dysfunction

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