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

NCT06334289 | Not Yet Recruiting

• 1 other identifier: YXLL-KY-2024(017)
• Study Type: observational
• Target: 338
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Perioperative Neurocognitive Disorders; Frail Elderly

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Postoperative 7-day incidence of PND

  The 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.

  30 days after surgery

Study Arms (2)

Frailty group

Non-frailty group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Elderly patients undergoing gastrointestinal surgery under general anesthesia.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Qianfoshan Hospital: lead

Central Study Contacts

yong t Sun, Ph.D

CONTACT

18660795201; sunyongtao1979@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: March 28, 2024
• Study Start: April 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 28, 2024

Record last verified: 2024-03