Department of Anesthesiology, Beijing Anzhen Hospital, Capital Medical University
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- microRNA
研究概览
简要总结
It has been reported that volatile anesthetics preconditioning mediates protection of organ via microRNA. We want to study on the effects of isoflurane preconditioning on expression of microRNA and mRNA in the specimens of internal mammary artery and ascending aorta.
详细描述
- Sixty patients scheduled for off-pump coronary artery bypass surgery were randomly assigned to isoflurane wash-in/wash-out group(S-I group, n=30)or propofol intravenous anesthesia group(P group, n=30).
- Anesthesia and monitoring method All patients were monitored according to the American Society of Anesthesia guidelines and received standard general induction of anesthesia.
- SI group:10min after intubation,begin to isoflurane wash-in/wash-out operation:isoflurane administration was interrupted for at least 10 min,by washout with a high fresh gas flow(10 l/min)to achieve a MAC value below 0.2. Following the interruption,sevoflurane was again washed in with a high fresh gas flow(6 l/min)to achieve 1 MAC end-tidal concentration as soon as possible,and repeated twice periods of 10 minutes.Discontinuation of the halogenated agent for at least 15 minutes during the last wash out time.
- P Group:propofol infusion 3-5μg/kg/h.
- When isoflurane inhaled anesthetic,propofol are stopped infusion.If during this interruption the BIS value increased to>50,0.5 mg/kg propofol was administered repeatedly in boluses until the BIS value have returned to<50.
6.1h after isoflurane preconditioning,specimens of internal mammary artery(surplus arterial tissue is obtained from the repair internal mammary artery)and ascending aorta(the stump after ascending aortic punch)will be saved, and before isoflurane preconditioning,1h,3h,5h after isoflurane preconditioning, central venous blood samples will also be drawn.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age >18 years
- •written informed consent;
- •scheduled procedures;
- •planned isolated OPCABG(multiple bypass are allowed; planned combined intervention such as CABG plus valve surgery are not allowed);
- •ejection fraction> 50%;
- •NYHA class Ⅱ~Ⅲ;
- •serum creatinine <150μmol / l;
- •preoperative platelet content > 100 × 109 / l;
- •preoperative hemoglobin> 120 g / l
排除标准
- •pregnancy;
- •planned valve surgery or surgery on the aorta;
- •left main coronary artery stenosis> 75%;
- •echocardiographic examination revealed moderate to severe mitral, tricuspid, or aortic regurgitation or stenosis;
- •unstable or ongoing angina;
- •recent (< 1 month) or ongoing acute myocardial infarction;
- •use of sulfonylurea, theophylline or allopurinol;
- •previous unusual response to an anesthetic agent;
- •inclusion in other randomised controlled studies in the previous 30 days; (10)any general anesthesia performed in the previous 30 days;
- •emergency operation (not scheduled);
- •kidney or liver transplant in medical history, liver cirrhosis (Child B or C);
- •chronic respiratory disease (such as chronic obstructive pulmonary emphysema)
研究组 & 干预措施
volatile anesthetics group
10min after intubation, begin to sevoflurane wash-in / wash-out operation: sevoflurane administration was interrupted for at least 10 min, by washout with a high fresh gas flow (10 l/min) to achieve a MAC value below 0.2. Following the interruption, sevoflurane was again washed in with a high fresh gas flow (6 l/min) to achieve 1 MAC end-tidal concentration as soon as possible, and repeated twice periods of 10 minutes. Discontinuation of the halogenated agent for at 15 minutes during the last wash out time.
干预措施: volatile anesthetics(isoflurane) (Drug)
propofol intravenous anesthesia group
propofol infusion 3-5μg / kg / h
干预措施: propofol intravenous anesthesia (Drug)
结局指标
主要结局
microRNA
时间窗: 1h after isoflurane treatment(specimens of internal mammary artery and ascending aorta stump are saved)
NOS3 mRNA,mRNA levels of adhesion molecule selectin -E,vascular cell adhesion molecule -1,vascular endothelial growth factor -1,intercellular adhesion molecule,RhoA and ROK
时间窗: 1h after isoflurane treatment(specimens of internal mammary artery and ascending aorta stump are saved)
phosphatidylinositol-3-kinase,alanine aminotransferase,endothelial nitric oxide synthase
时间窗: 1h after isoflurane treatment(specimens of internal mammary artery and ascending aorta stump are saved)
次要结局
- Change from microRNA(befor isoflurane treatment,1h,3h,5h after isoflurane treatment(central venous blood samples are drawn))
- Change from ON content in serum,vascular cell adhesion molecule-1,intercellular adhesion molecules-1,adhesion molecule selectin-E,monocyte chemoattractant protein-1 and vascular endothelial growth factor-1(befor isoflurane treatment,1h,3h,5h after isoflurane treatment(central venous blood samples are drawn))
- Change from tumor necrosis factor-a,interleukin 1β,IL-6,IL-8 and IL-10(befor isoflurane treatment,1h,3h,5h after isoflurane treatment(central venous blood samples are drawn))
研究者
Liang Zhang
Principal Investigator
Beijing Anzhen Hospital