Effects of Dexmedetomidine on Patients With Coronary Heart Disease After Percutaneous Coronary Intervention:A Double-Blinded, Randomised Controlled Trial
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- the incidence of myocardial infarction type 4a (MI4a)
研究概览
简要总结
Coronary heart disease has a high incidence and high death rate. Percutaneous coronary intervention (PCI) is an important method for the treatment of coronary heart disease (CHD). However, PCI may cause myocardial cell injury and myocardial infarction 4 Type(MI4a, Type 4 a myocardial infarction related to PCI). Dexmedetomidine(Dex) is the only anesthetic which has sedative and analgesic effects. Dex currently has been widely used in perioperative management of various surgical.This study intends to verify the effect of heart protection of Dex in perioperative.
详细描述
Participants will be randomly assigned, in a 1:1 ratio, to receive Dexmedetomidine or control (0.9 %Sodium Chloride Solution,0.9%NaCl). The randomization sequence will be computer-generated, and randomization will be performed in blocks and will be stratified according to participating center. Dexmedetomidine and 0.9 % NaCl solution will be transfused when the operation began, ending 24 hours after the surgery. Troponin I level(but are not limited to these data) at pre-operation and 3h, 6h,12h, 24h, 48h after PCI will be recorded. At the same time, other dates will be recorded.The participation of each patient is scheduled for 12 months.
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, Investigator)
盲法说明
all of the participants, operators, investigators and outcomes assessors don't know the grouping situation before the study finished.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the patients were coincided to CHD combined with depression and anxiety according to diagnostic standard of World Health Organization(WHO)who need receive selective PCI in the First Affiliated Hospital of Xi'an Jiaotong University;
- •people aged over 18;
- •patients who will undergo PCI with Hamilton Anxiety scale of 14 points or more.
排除标准
- •severe comorbidity history;
- •coronary stenosis less than 70%;
- •severe cardiac dysfunction;
- •central nervous system disease;
- •troponin I levels have rised before entering the hospital;
- •pregnant woman；
- •history of mental disorders;
- •alcoholic and long-term use of sedatives and opioids history;
- •drug allergy history.
研究组 & 干预措施
study group
when the operation begin,dexmedetomidine will be pumped at 0.4μg/kg•h for 15 minutes ,then reduce the dose to 0.2μg/kg•h until 24 h after PCI.
干预措施: Dexmedetomidine (Drug)
control group
0.9%NaCl solution 0.1ml/kg•h when the operation begin and stopped until 24 h after PCI.
干预措施: 0.9%NaCl solution (Drug)
结局指标
主要结局
the incidence of myocardial infarction type 4a (MI4a)
时间窗: detect serum TnI level before and 3h、6h、12h、24h、48h after PCI
serum troponin(TnI) values at 48h after PCI is an important indicator for diagnosis of acute myocardial injury myocardial damage when troponin I lever rise.
次要结局
- post-procedural cardiac function(once 3 months for 6 months after PCI)
- major adverse cardiac events(MACEs)(once 3 months for 12 months after PCI)
- systemic inflammatory markers(before and 1 week after PCI)