Risk Factor Analysis of Postoperative Cognitive Dysfunction and Its Association With Inflammation Related Gene Polymorphism
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- Determine the relevance of inflammation-related genes and SNPs of susceptible POCD
研究概览
简要总结
This study use Loewenstein cognitive function rating scale to meet the standards of the elderly cognitive function assessment. POCD diagnostic criteria used is the recommended value Z current international law, in order to reduce the effects of exercise, we selected 50 cases of patients with age-matched healthy control group as a spouse, the same scale testing. And Loewenstein Assessment Scale cognitive function after some domestic research proved to have good sensitivity, and easy to test small changes in cognitive ability.
Before the investigation began strict inclusion and exclusion criteria, the use of simple intelligence scale exclude preoperative cognitive decline in the elderly significantly, the use of depression rating scale for anxiety rating scale before surgery to exclude severe depression and severe anxiety in elderly self self patient. Testing by the same person in the same way neurocognitive assessment test twice, 7 days apart.
Studies in Chinese population, susceptibility SNPs and genetic POCD but there are few reports of this project uses 1: 1 matched case-control study, by comparison POCD SNPs and control groups of different polymorphisms, polymorphisms Discussion Han population of postoperative cognitive dysfunction associated with susceptibility to find Chinese Han population of postoperative cognitive disorders genetic susceptibility markers, which provide scientific screening and early diagnosis of postoperative cognitive impairment at high risk in accordance with
详细描述
- study 1.1 The study inclusion criteria: The study in January 2015 - June 2015 Xuzhou Medical College Hospital orthopedic ward in elderly patients, level of education for primary ((0 <schooling ≤6). Check all other indicators of the patients were in the normal range, no liver, kidney, lung, heart and other organ dysfunction, the operation time was 60 ~ 180min, ASA classified as class II.
1.2 study exclusion criteria: Severe vision (1) no history of cerebrovascular disease (2) Other medical history (3) No alcohol dependence and other substance abuse history (4) to cause central nervous system damage did not affect cognitive function can not affect cognitive tests, hearing and limb movement disorder (5) without mental illness (6) Exclude known preoperative cognitive dysfunction (7) can not articulate the patient's own meaning or do not match, the patient can not communicate very well.
In contrast to cases by sex and age and frequency matching. Study subjects were Chinese Han population, and signed informed consent form, a collection of peripheral blood specimens (5mlEDTA anticoagulated blood). At the same time, by specially trained investigators to complete the epidemiological survey. 2. field epidemiology survey methodology 2.1 Questionnaire items (perioperative observations Indicator) 2.1.1 Preoperative: gender, age, education, past medical history (hypertension, diabetes, chronic lung disease), surgery.
2.1.2 Surgery: The operation time, the number of anesthesia, fentanyl, remifentanil, the dosage of atropine, hypotension, hypertension. Intraoperative hypotension cases: surgery or any time SBP≤90 mm Hg compared with preoperative blood pressure reduced by more than 30% for longer than 5min; intraoperative hypertension cases: surgery any time SBP≥140 / 90mmHg or comparing preoperative more than 30% increase in blood pressure over the duration of 5min.
2.1.3 Postoperative: Postoperative 7d or prior to discharge using a visual analog scale (vasual analogue scale, VAS) to assess the degree of pain the patient and postoperative complications were recorded (with or without infection, reoperation).
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Education for primary ((0 <schooling ≤6)
- •The operation time was 60 ~ 180min
- •ASA classification as Class II
排除标准
- •No history of cerebrovascular disease
- •No history of central nervous system injury caused by the impact of other cognitive functions
- •No alcohol dependence and other substance abuse history
- •No vision can severely affect cognitive tests, hearing and limb movement disorder
结局指标
主要结局
Determine the relevance of inflammation-related genes and SNPs of susceptible POCD
时间窗: 1 year
In this study of an international research organization POCD recommended Z-score method to determine postoperative cognitive dysfunction, and is divided into POCD and non POCD group, if the composite Z-score ≥1.96 or have two or more individual test Z-score greater than or equal 1.96 considers the patient POCD group, otherwise non POCD group. They were recorded POCD group and non-POCD group education of patients, medical history, surgery time, anesthesia time, and the amount of narcotic drugs, hypotension, hypertension, postoperative pain, complications, smoking, drinking, blood samples were analyzed patient patients with IL-1β, IL-6, IL-10, VDR, BDNF gene polymorphism
次要结局
未报告次要终点
研究者
dengji wang
Investigator
Xuzhou Medical University