Effect of Dexmedetomidine Preconditioning on Myocardial Ischemia-reperfusion : a Randomized, Double-blind Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- troponin T level
研究概览
简要总结
About 200000 cardiac operations are performed in China every year. Cardiopulmonary bypass is the basic strategy of open-heart surgery, which may lead to myocardial ischemia-reperfusion injury and low cardiac output syndrome. It will inevitably affect the patient's postoperative recovery. A number of studies have shown that dexmedetomidine, as an auxiliary sedative, has the effects of inhibiting stress response, antiarrhythmia and cardiac protection.Dexmedetomidine has been widely used in anesthesia in cardiac surgery. However, at present, few clinical studies pay attention to its mechanism. In this study, dexmedetomidine will be used in cardiac surgery with cardiopulmonary bypass to explore the mechanism of cardiac ischemia-reperfusion injury and the protective effect of dexmedetomidine.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-70 years
- •American Society of Anesthesiologists(ASA) physical status of I-Ⅳ
- •BMI: 18.5-28 kg/m2
- •Type of operation: elective open-heart surgery with cardiopulmonary bypass
- •The patient and/or family members have signed the informed consent.
排除标准
- •Preoperative diagnosis of heart failure 、gradeⅡ-Ⅲ heart block and diabetes
- •Severe coagulation dysfunction
- •Severe heart, lung, liver and kidney insufficiency
- •Used to have immunosuppressive therapies such as radiotherapy, chemotherapy and glucocorticoid, or have immune system diseases
- •Perioperative allogeneic blood transfusion
研究组 & 干预措施
Group D
The participant will be infused with dexmedetomidine during anesthesia to protect the myocardium.
干预措施: dexmedetomidine (Drug)
Group R
The participant will use saline of the same volume as dexmedetomidine as a placebo during anesthesia.
干预措施: Placebo (Drug)
结局指标
主要结局
troponin T level
时间窗: 72 hours after operation
the level of troponin in the participant's serum
次要结局
- AQP4、iNOS andTNF-α level(the end of the operation)
研究者
Yibin Qin
associate chief physician
Affiliated Hospital of Nantong University