Effect of Controlled Hypotension Guided by Cerebral Oxygen Saturation Monitoring on Postoperative Cognitive Function of Elderly Patients Undergoing Shoulder Arthroscopy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 400
- 主要终点
- Incidence of postoperative cognitive dysfunction(POCD) 3 days after operation
研究概览
简要总结
To observe whether adjusting the level of intraoperative controlled hypotension through cerebral oxygen saturation monitoring can improve postoperative cognitive function(POCD) and reduce postoperative neurological complications, a prospective randomized controlled study method will be used in this study. 400 elderly patients undergoing shoulder arthroscopic surgery under general anesthesia combined with brachial plexus block will be selected. They will be randomly divided into control group and experimental group according to whether cerebral oxygen saturation monitoring was used during the operation. The control group maintain the target blood pressure only according to the controlled hypotension guideline, and the experimental group adjust the controlled hypotension level under the guidance of cerebral oxygen saturation monitoring. The general condition, operation, anesthesia and hospitalization related data of the patients will be recorded.
详细描述
Cognitive function will be evaluated within 3 days before operation and 3 days, 14 days and 3 months after operation. Delirium and VAS pain score will be evaluated 24 hours after operation. Venous blood will be taken before operation and 24 hours after operation to detect cognitive related markers and inflammatory factors. In addition, 10 blood samples of patients in each group were selected for RNA omics test. One month, six months and 12 months after operation, cognitive function was evaluated by cognitive function telephone questionnaire (TICS-M), and the ability of daily living was evaluated by IDAL. In addition, 20 non-surgical patients were selected for cognitive function evaluation at the same time point as the exercise effect of POCD detection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
In this study, different researchers will be responsible for randomization, anesthesia and visit. A researcher is responsible for assigning random numbers to ensure the randomness of the study groups. Due to the intraoperative monitoring of cerebral oxygen saturation in the experimental group, it is impossible to blind the researchers implementing anesthesia. In order to ensure that the whole study is not affected by subjective factors, the visiting researchers are blinded, who do not know the anesthesia grouping, and are responsible for case enrollment screening, signing informed consent, preoperative and postoperative cognitive function evaluation, postoperative pain evaluation, complications and safety evaluation.
入排标准
- 年龄范围
- 60 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing elective shoulder arthroscopic surgery under general anesthesia combined with brachial plexus block;
- •ASA grade ≤ grade III;
- •Patients Can communicate normally, can cooperate and complete cognitive function test;
- •Patients volunteered and signed informed consent.
排除标准
- •BMI < 18 or > 27 kg / m2;
- •Previous history of dementia, psychosis or other central nervous system diseases or mental diseases, such as cerebral infarction, stroke, Parkinson's disease, etc;
- •Patients taking sedatives or antidepressants;
- •Alcoholics or drug addicts;
- •Illiteracy, severe hearing or visual impairment;
- •Patients with cognitive impairment before operation (MMSE score < 23);
- •Patients with peripheral vascular diseases and contraindication of arterial puncture and catheterization;
- •Patients unable to carry out long-term follow-up or poor compliance.
结局指标
主要结局
Incidence of postoperative cognitive dysfunction(POCD) 3 days after operation
时间窗: 3 days after operation
The Neuropsychological test, includes: (1) Vocabulary learning; (2) Vocabulary recall; (3) Connection test; (4) Stroop Color word interference; (5) Letter-number coding test.
次要结局
- Incidence of postoperative cognitive dysfunction(POCD) 14 days after operation(14 days after operation)
- Incidence of postoperative cognitive dysfunction(POCD) 3 months after operation(3 months after operation)
- Expression changes of cognitive function related markers 24 hours after operation(24 hours after operation)
- Hospital stay(through hospitalization period, an average of 15 day)
- Hospital expenses(through hospitalization period, an average of 15 day)
- Perioperative complications(1 day (during the surgical period))