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A Predictive Study of Peripheral Blood Biomarkers on Postoperative Neurocognitive Dysfunction in Elderly Frail and Non-frail Patients Undergoing Gastrointestinal Surgery

A Predictive Study of Peripheral Blood Biomarkers on Postoperative Neurocognitive Dysfunction in Elderly Frail and Non-frail Patients Undergoing Gastrointestinal Surgery

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06334289
Enrollment
338
Registered
2024-03-28
Start date
2024-04-01
Completion date
2024-12-31
Last updated
2024-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frail Elderly, Perioperative Neurocognitive Disorders

Keywords

Peripheral blood biomarkers, inflammatory markers, Alanine aminotransferase, blood lipids, vitamin D

Brief summary

Perioperative neurocognitive impairment (PND) mainly includes acute postoperative delirium (POD) and persistent postoperative cognitive impairment (POCD), which are common postoperative complications in elderly patients. Perioperative neurocognitive impairment (PND) is attracting increasing attention, but its exact mechanism is still unclear. The diagnosis of PND lacks the gold standard, so it is difficult to determine the incidence rate. At present, the diagnosis is mainly conducted through the scale. Therefore, this study aims to explore the correlation between peripheral blood biomarkers and PND in elderly frail patients undergoing gastrointestinal surgery.

Interventions

None listed

Sponsors

Qianfoshan Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age ≥ 65 years old * American Society of Anesthesiologists (ASA) classification: grades I-IV * Hospitalization time ≥ 3 days

Exclusion criteria

* The revised version of the Cognitive Function Telephone Questionnaire (TICS-M) was used before surgery to determine cognitive impairment (TICS-M score ≤ 27 points) * Refuse to participate * Emergency surgical patients * Central nervous system diseases (dementia, depression, etc.) * Severe renal insufficiency (requiring dialysis) * Long term use of psychotropic drugs (such as clozapine, risperidone, olanzapine, haloperidol, chlorpromazine, etc.) * History of alcohol abuse or use of acetylcholine drugs * The same patient can only be included once, regardless of whether the reason for the second surgery is related to the first cause

Design outcomes

Primary

MeasureTime frameDescription
Postoperative 7-day incidence of PND30 days after surgeryThe primary outcome of this study is the postoperative 7-day incidence of PND Blood samples (approximately 3ml each time) were taken before anesthesia induction and after the removal of the tracheal catheter, and then standardized tests were performed to analyze the blood markers related to this study. The follow-up method used was the revised version of the Cognitive Function Telephone Questionnaire (TICS-M), and the scores were evaluated through telephone follow-up. Screening was conducted one day before surgery, and follow-up and diagnosis were conducted on the 7th and 30th days after surgery. When the reliable change index of TICS-M score decreases by 1-2, POCD is considered mild. When the reliable change index of TICS-M score decreases by ≥ 2, POCD is considered severe. After follow-up, the values of serum biomarkers were obtained from two groups of patients for data analysis, and the correlation between the biomarkers and the two groups was obtained.

Contacts

Primary Contactyong t Sun, Ph.D
sunyongtao1979@163.com18660795201

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026