A Prospective, Randomized Trial to Study the Effects of Different Anesthetic Agents on the Perioperative Immune Response
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- UMC Utrecht
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Perioperative inflammatory response through measurement of expression and responsiveness of Toll-like Receptor (TLR) 2 and 4 of monocytes from full blood samples.
研究概览
简要总结
The purpose of this study is to investigate the effects of total intravenous anesthesia versus volatile anesthesia on the perioperative inflammatory response during and after major surgery.
详细描述
Patients undergoing major surgical procedures, in particular those undergoing cardiac surgery, develop a severe inflammatory response in up to 50% of cases leading to increased mortality and morbidity. The inflammatory response depends on the surgical procedure and on patient related factors like genetic predisposition and co morbidities. However, in vitro studies showed that the type and duration of general anaesthesia also influences the extent of perioperative inflammation.
Comparison: total intravenous anesthesia by propofol is compared to volatile anesthesia by isoflurane with respect to development of perioperative inflammatory response.
The IRAS study is a single centre study, executed in the University Medical Centre Utrecht, The Netherlands. Four different patient groups are included. 1) Patients undergoing coronary artery bypass grafting (CABG) with use of cardiopulmonary bypass (CPB), 2) patients undergoing aorta aneurysm repair via endovascular approach and 3) via conventional open procedure, and 4) patients undergoing surgery for replacement of implantable cardioverter defibrillator (ICD).
The IRAS is a prospective, randomized clinical trial. Patients are randomly assigned to a intravenous or a balanced anaesthesia technique. Peripheral blood samples are drawn before, during and up to 72h after surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients older than 18 years and planned for elective Coronary Artery Bypass Grafting (CABG), aorta surgery or Implantable Cardioverter Defibrillator (ICD) replacement
排除标准
- •Emergency operations
- •Patients undergoing combined or re-do procedures
- •Patients who are diagnosed with or undergoing treatment for a steroid or hormone disorder, excluding diabetes
- •Patients suffering from chronic inflammatory diseases
- •Patients suffering form current infections
- •Patients currently treated with steroids
- •Patients undergoing treatment or care for a malignancy
- •Patients participating in another study that may interfere with the endpoints of the IRAS trial
结局指标
主要结局
Perioperative inflammatory response through measurement of expression and responsiveness of Toll-like Receptor (TLR) 2 and 4 of monocytes from full blood samples.
时间窗: 72 hours
次要结局
- Need of vasoactive medication to develop predefined haemodynamic goals(72 hours)
- Parameters of systemic haemodynamics(72 hours)
- Biochemical parameter of myocardial ischaemia and infarction (Troponin-I), measured immediately before and after surgery, 24 hr and 72hr after surgery(72 hours)
- Serious adverse events assessed 3 days after surgery, at discharge, 30 days and one year after surgery(1 year)