Biomarkers and Risk Factors for Perioperative Neurocognitive Dysfunction in Elderly Patients

Biomarkers and Risk Factors for Perioperative Neurocognitive Disorders in Elderly Non-neurosurgical Patients

Basic information and biological samples of patients were collected preoperatively and intraoperatively, and patients were divided into case and control groups by cognitive function assessment postoperatively, and risk factors and biomarkers of perioperative cognitive dysfunction were derived by analyzing and statistically processing basic information and biological samples.

Study Overview

• Status: Recruiting
• Conditions: Perioperative Neurocognitive Dysfunction
• Intervention / Treatment: Diagnostic test: Pittsburgh sleep quality index; Diagnostic test: Self-rating depression scale; Diagnostic test: Montreal Cognitive Assessment

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Wenying Chi, Master; Phone Number: 18654557772; Email: cwy2907@zxyy.cn

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250000
      • Recruiting
      • Jinan Central Hospital
      • Contact: Wenying Chi, Master; Phone Number: 18654557772; Email: cwy2907@zxyy.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Elderly people older than 65 years old who have been identified for non-neurosurgical procedures at Jinan Central Hospital

Description

Inclusion Criteria:

• Age more than or equal to 65 years old
• ASA classification Ⅰ~Ⅲ grade

Exclusion Criteria:

• History of previous Craniocerebral surgery or Craniocerebral trauma
• Inability to successfully complete preoperative psychological function tests
• Those who are severely deaf, speech impaired and otherwise unable to communicate.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with perioperative neurocognitive dysfunction	Diagnostic test: Pittsburgh sleep quality index; The scale is suitable for evaluating sleep quality in patients with sleep disorders and psychiatric disorders, as well as for assessing sleep quality in the general population.; Diagnostic test: Self-rating depression scale; The scale is easy to use, can fairly intuitively reflect whether the patient has depression and the degree of depression, has been widely used in outpatient gross screening, mood state assessment.; Diagnostic test: Montreal Cognitive Assessment; The scale is a tool used for rapid screening of mild cognitive dysfunction to identify patients with preoperative cognitive dysfunction
Patients without perioperative neurocognitive dysfunction	Diagnostic test: Pittsburgh sleep quality index; The scale is suitable for evaluating sleep quality in patients with sleep disorders and psychiatric disorders, as well as for assessing sleep quality in the general population.; Diagnostic test: Self-rating depression scale; The scale is easy to use, can fairly intuitively reflect whether the patient has depression and the degree of depression, has been widely used in outpatient gross screening, mood state assessment.; Diagnostic test: Montreal Cognitive Assessment; The scale is a tool used for rapid screening of mild cognitive dysfunction to identify patients with preoperative cognitive dysfunction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perioperative neurocognitive dysfunction	Identification of patients who develop perioperative neurocognitive disorders after surgery by postoperative follow-up with cognitive function tests	1 year postoperative

Collaborators and Investigators

• Sponsor: Jinan Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: September 12, 2023
• First Submitted That Met QC Criteria: September 12, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 12, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 2023-076-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No