An observational study in Systemic Inflammatory Response Syndrome and Myocardial Ischemia, sponsored by UMC Utrecht. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-06-24.
Sponsored by UMC Utrecht · Observational
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.
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.
3,233 studies on the registry are indexed under Myocardial Ischemia; 396 are open to participants now.
This study's enrollment of 120 is below the median of 332 across 1,140 observational studies indexed under Myocardial Ischemia.
Browse Myocardial Ischemia studies →UMC Utrecht is the lead sponsor of 350 studies on the registry; 80 are open to participants now.
Counted across the registry records on this site, refreshed daily.
specific surgical patients receiving general anesthesia of university teaching hospital
Exclusion Criteria:
elective CABG only patients
elective ICD replacement surgical patients requiring general anesthesia
Perioperative inflammatory response through measurement of expression and responsiveness of Toll-like Receptor (TLR) 2 and 4 of monocytes from full blood samples.
Time frame: 72 hours
Parameters of systemic haemodynamics
Time frame: 72 hours
Need of vasoactive medication to develop predefined haemodynamic goals
Time frame: 72 hours
Biochemical parameter of myocardial ischaemia and infarction (Troponin-I), measured immediately before and after surgery, 24 hr and 72hr after surgery
Time frame: 72 hours
Serious adverse events assessed 3 days after surgery, at discharge, 30 days and one year after surgery
Time frame: 1 year
This study is completed, as verified in Jun 2008. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
UMC Utrecht