NCT06044207

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

September 21, 2023

Status Verified

May 1, 2023

Enrollment Period

2 years

First QC Date

September 12, 2023

Last Update Submit

September 12, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Perioperative neurocognitive dysfunction

    Identification of patients who develop perioperative neurocognitive disorders after surgery by postoperative follow-up with cognitive function tests

    1 year postoperative

Study Arms (2)

Patients with perioperative neurocognitive dysfunction

Diagnostic Test: Pittsburgh sleep quality indexDiagnostic Test: Self-rating depression scaleDiagnostic Test: Montreal Cognitive Assessment

Patients without perioperative neurocognitive dysfunction

Diagnostic Test: Pittsburgh sleep quality indexDiagnostic Test: Self-rating depression scaleDiagnostic Test: Montreal Cognitive Assessment

Interventions

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.

Patients with perioperative neurocognitive dysfunctionPatients without perioperative neurocognitive dysfunction

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.

Patients with perioperative neurocognitive dysfunctionPatients without perioperative neurocognitive dysfunction

The scale is a tool used for rapid screening of mild cognitive dysfunction to identify patients with preoperative cognitive dysfunction

Patients with perioperative neurocognitive dysfunctionPatients without perioperative neurocognitive dysfunction

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinan Central Hospital

Jinan, Shandong, 250000, China

RECRUITING

Central Study Contacts

Wenying Chi, Master

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2023

First Posted

September 21, 2023

Study Start

June 1, 2023

Primary Completion

June 1, 2025

Study Completion

January 1, 2026

Last Updated

September 21, 2023

Record last verified: 2023-05

Locations