Inflammatory Response During Anesthesia and Surgery (IRAS)
Recruitment status was Active, not recruiting
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.
Systemic Inflammatory Response Syndrome
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Prospective, Randomized Trial to Study the Effects of Different Anesthetic Agents on the Perioperative Immune Response|
- Assessment of perioperative inflammatory response through measurement of expression of TLR-2 and 4 on monocytes and via in vitro assessment of responsiveness of immune system to exogenous ligands by measuring resulting cytokines in full blood samples [ Designated as safety issue: No ]
- Parameters of systemic haemodynamics [ Designated as safety issue: No ]
- Need of vasoactive medication to develop predefined haemodynamic goals [ Designated as safety issue: No ]
- Biochemical parameter of myocardial ischaemia and infarction (Troponine-I), measured immediately before and after surgery, 24 hr and 72hr after surgery [ Designated as safety issue: No ]
- Serious adverse events assessed 3 days after surgery, at discharge, 30 days and one year after surgery [ Designated as safety issue: No ]
|Study Start Date:||March 2006|
|Estimated Study Completion Date:||March 2009|
|Estimated Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
elective CABG patients
elective ICD replacement surgical patients
elective endovascular aorta repair patients
elective conventional abdominal aorta aneurysm surgical patients
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00356746
|UMC Utrecht, Division of Perioperative Care and Emergency Medicine, Department of Anesthesiology|
|Utrecht, Netherlands, 3508 GA|
|Study Chair:||Cor J Kalkman, Prof MD PhD||University Medical Centre Utrecht, The Netherlands|
|Study Director:||Wolfgang F Buhre, MD PhD||University Medical Centre Utrecht, The Netherlands|
|Study Director:||Gerard Pasterkamp, Prof MD PhD||University Medical Centre Utrecht, The Netherlands|