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

Frail Elderly Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06334289
• Other study ID #: YXLL-KY-2024(017)
• Status: Not yet recruiting
• Start date: April 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Qianfoshan Hospital
• Contact: yong t Sun, Ph.D
• Phone: 18660795201
• Email: sunyongtao1979[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 338
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Frail Elderly
• Neurocognitive Disorders

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Qianfoshan Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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