A Predictive Study of Peripheral Blood Biomarkers on Postoperative Neurocognitive Dysfunction in Elderly Frail and Non-frail Patients Undergoing Gastrointestinal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 338
- 主要终点
- Postoperative 7-day incidence of PND
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 65 years old
- •American Society of Anesthesiologists (ASA) classification: grades I-IV
- •Hospitalization time ≥ 3 days
排除标准
- •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
结局指标
主要结局
Postoperative 7-day incidence of PND
时间窗: 30 days after surgery
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.
次要结局
未报告次要终点
研究者
Yongtao Sun
professor
Qianfoshan Hospital