Clinical trial NCT06028568: The Reliability and Validity of Perioperative Cognitive Test Network Platform for Monitoring Neurocognitive Changes
Official title: The Reliability and Validity of Perioperative Cognitive Test Network Platform for Monitoring Perioperative Neurocognitive Function Changes in Patients Undergoing Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Perioperative Neurocognitive Disorders
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2023-09-08
Enrollment: 400
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will include two groups: elderly healthy volunteers and elderly patients undergoing abdominal surgery.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Reliability
timeFrame: Baseline Test：1 day before operation, Second Test: Day 7 after operation
measure: Validity
timeFrame: Baseline Test：1 day before operation, Second Test: Day 7 after operation
Secondary outcomes:
measure: PND (Perioperative neurocognitive disorders)
timeFrame: Baseline Test：1 day before operation, Second Test: Day 7 after operation
Other outcomes:
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