The Association Between Blood Biomarkers and Postoperative Delirium in Elective Non-Cardiac Surgery Under General Anesthsia.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- serum concentration change in biomarker of endothelial dysfunction
研究概览
简要总结
More than 20% of patients over 60 years old develop postoperative delirium following non-cardiac surgery . Delirium increases morbidity and mortality , and may lead to long-term cognitive impairment . The underlying mechanisms behind delirium are not understood , endothelial dysfunction and disruption of the blood brain barrier (BBB ) caused by perioperative systemic inflammation may play a important role in the development of delirium . This study intends to evaluate the relationship between neuroinflammation and postoperative delirium in elderly non-cardiac surgery patients . The results of the study are to identify risk factors and explore the biomarkers most closely linked to each step of the proposed pathway .
详细描述
The investigators do the neuropsychological tests , Mini-Mental score examination (MMSE ) , Charlson Comorbidity Index (CCI ) , Quality of Recovery Score - 40 (QoR-40 ) 1 day before the surgery（baseline ) . Serum of the patients was collected before operation and at POD1 , and then detect the concentration change of biomarkers of endothelial dysfunction , blood brain barrier disruption and neuronal injury . Also , the patients were interviewed once before discharge from PACU and twice on postoperative days 1-3 by the Confusion Assessment Method and then divided them into POD and non-POD groups . Meanwhile , the severity of pain (Numerical Rating Scale（NRS )) was evaluated at the same time and QoR-40 at 1 day after surgery .
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing selective major noncardiac surgery and general anesthesia;
- •Age 60-90 yrs;
- •Anesthesia Society of American (ASA) Scale II~III;
- •Anticipated surgery time 2-6 hrs
- •Written informed consent;
排除标准
- •decline to participate
- •Dementia patients（Mini-mental state examination< 20）
- •Factors existed that affect cognition assessment such as language,visual,and auditory dysfunction.
结局指标
主要结局
serum concentration change in biomarker of endothelial dysfunction
时间窗: baseline, postoperative day 1
C-terminal endothelin-1 (CT-proET-1) to be measured at 2 time points
serum concentration change in biomarker of blood brain barrier disruption
时间窗: baseline, postoperative day 1
caveolin-1 to be measured at 2 time points
The incidence of postoperative delirium
时间窗: From day 0 to up to 3 days after the surgery
The patients were interviewed one day before the surgery and on postoperative days 1-3 by the Confusion Assessment Method and then divided them into POD and non-POD groups.
serum concentration change in biomarker of neuronal injury
时间窗: baseline, postoperative day 1
Neurofilament light (NfL) to be measured at 2 time points
次要结局
- Quality of Recovery Score - 40 (QoR-40) at baseline(1 day before the surgery(baseline))
- The severity of pain after surgry(From day 0 to up to 3 days after the surgery)
- Quality of Recovery Score - 40 (QoR-40) after surgry(1 day after the surgery)
- The severity of pain at baseline(1 day before the surgery(baseline))
研究者
Han Yuan
Director
Xuzhou Medical University