The Reliability and Validity of Perioperative Cognitive Test Network Platform for Monitoring Neurocognitive Changes

NCT ID: NCT06028568

Last Updated: 2023-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-01

Study Completion Date

2024-03-31

Brief Summary

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This study aimed to analyze the reliability and validity of the results of the new designed perioperative cognitive test network platform, and to judge the reliability and scientific nature of the perioperative cognitive test. And then to explore whether the perioperative cognitive test network platform can be used to evaluate the changes of perioperative cognitive function of patients.

Detailed Description

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Two cohorts of elderly healthy volunteers and elderly patients undergoing abdominal surgery will be included in this study. The cognitive function of the patients was tested one day before and seven days after operation. Healthy volunteers had two cognitive function tests at the same interval. The normality test is used to evaluate whether the test results accord with the normal distribution. The internal consistency of the test was evaluated by calculating the Cronbach coefficient, the content validity was evaluated by experts and the content validity index was calculated, and the construct validity of the test was evaluated by exploratory factor analysis and confirmatory factor analysis. The validity of the test was evaluated by calculating the effect scale.

Conditions

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Perioperative Neurocognitive Disorders

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Study Groups

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Elderly patients undergoing surgery

Older than or equal to 65 years of age; patients who intend to undergo major abdominal surgery under general anesthesia (grade 3-4 surgery based on surgical grade)

No interventions assigned to this group

Elderly healthy volunteers

Age-and sex-matched community population

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age over 65
* Scheduled for abdominal surgery under general anesthesia (grade 3-4 surgery based on surgical grade)
* Informed consent has been obtained
* Healthy volunteer groups are listed as age-and sex-matched community groups

Exclusion Criteria

* Unable to follow instruction and finish the firtst procedure
* Has severe visual or auditory problems
* History of drug or alcohol abuse (drinking more than 5U daily in the past 3 months, 1U equals 10ml or 8g pure alcohol, equivalent to \>50 liquor over 100ml, two two
* Are diagnosed neuropsychological disease that needs treatment
* Clear history of severe cerebrovascular diseases (including cerebral hemorrhage and cerebral infarction), Parkinson's syndrome, schizophrenia, bipolar disorder, depression, dementia, Alzheimer's disease, etc
* Severe head trauma, carbon monoxide poisoning and other loss of consciousness more than 30 minutes
* MMSE score ≤23
* Participated this study or being participating other clinical research
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Zhixin Wu, physician

Role: CONTACT

18392187971

Other Identifiers

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KY20232188-C-1

Identifier Type: -

Identifier Source: org_study_id

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