The Second Affiliated Hospital of Nanchang University
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- wave time-frequency analysis
研究概览
简要总结
The goal of this observational study is to compare the perioperative EEG characteristics and the incidence of short-term cognitive dysfunction in patients with postoperative delirium and non-postoperative delirium after elderly (> 65 years old) patients undergoing major gastrointestinal surgery under general anesthesia. The main question it aims to answer are: • The correlation between postoperative cognitive dysfunction and postoperative EEG features was evaluated.• To analyze the correlation between EEG characteristics and clinical risk factors of delirium after major abdominal gastrointestinal surgery under general anesthesia in elderly patients.Participants will collect EEG before and after operation and collect the incidence of postoperative cognitive function to explore the mechanism of postoperative delirium and predict postoperative cognitive dysfunction.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Education level in primary school or above;
- •Age ≥65 years old, gender is not limited;
- •Good communication ability, language expression ability, mental state and consciousness state;
- •Preoperative simple mental state scale score ≥27 points;
- •no history of craniocerebral diseases;
- •For patients who plan to choose abdominal surgery under general anesthesia, the operation time is expected to be about 2h-4h;
- •ASA anesthesia grade I ~ III;
- •No general anesthesia contraindications;
- •Sign informed consent voluntarily;
排除标准
- •Relative contraindications of general anesthesia: patients with serious heart and lung function diseases, drug allergy history, etc.
- •Patients with a history of mental illness or long-term psychiatric drugs (dementia, schizophrenia), chronic analgesic drug use history, alcoholism history and cognitive dysfunction;
- •any cerebrovascular accident occurred within 3 months, such as stroke, transient ischemic attack (TIA), etc.
- •Diabetic patients with severe diabetic complications (diabetic ketoacidosis, hyperosmolar coma, various infections, macrovascular disease, diabetic nephropathy);
- •Chronic hypoxia and carbon dioxide storage, such as chronic obstructive emphysema;
- •a long history of alcohol abuse;
- •Unable to cooperate to complete the test, the patient or family rejected the participant.
结局指标
主要结局
wave time-frequency analysis
时间窗: one day before surgery, 7-10 days after surgery
The characteristics of four kinds of brain wave α, β ,δ and θ were analyzed by professional EEG analysis software
Incidence of postoperative short-term cognitive dysfunction
时间窗: postoperative 1,3,6 months
A telephone return visit was conducted on patients using the Revised Cognitive Function Telephone Questionnaire (TICS-M) at 1, 3, and 6 months after discharge.The total score was less than 28 points, which was considered as cognitive impairment.
EEG event-related potential accuracy and response time
时间窗: one day before surgery, 7-10 days after surgery
The accuracy of task EEG was analyzed statistically by using professional EEG analysis software
P300 latency and peak changes
时间窗: one day before surgery, 7-10 days after surgery
The feature analysis of event-related potentials was carried out through professional EEG analysis software
次要结局
- Mean pressure(perioperative period)
- Complication(During the perioperative period, up to 1 month after surgery)
- Length of hospitalization(After the patient is discharged from the hospital, average 1 month)
- Maximum postoperative C-reactive protein (CRP)(Up to 1 month after surgery)
- Diastolic pressure(perioperative period)
- Minimum postoperative albumin(Up to 1 month after surgery)
- Systolic pressure(perioperative period)
- Heart rate(perioperative period)
- Postoperative pain(1, 3, and 7 days after surgery)
研究者
Fuzhou Hua
Director
Second Affiliated Hospital of Nanchang University