Inflammatory Response During Anesthesia and Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective, Randomized Trial to Study the Effects of Different Anesthetic Agents on the Perioperative Immune Response

Conditions
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Systemic Inflammatory Response Syndrome, Myocardial Ischemia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients older than 18 years and planned for elective Coronary Artery Bypass Grafting (CABG), aorta surgery or Implantable Cardioverter Defibrillator (ICD) replacement Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>elective CABG only patients | |
| 2<br>elective ICD replacement surgical patients requiring general anesthesia | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative inflammatory response through measurement of expression and responsiveness of Toll-like Receptor (TLR) 2 and 4 of monocytes from full blood samples. |  | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parameters of systemic haemodynamics |  | 72 hours | 
| Need of vasoactive medication to develop predefined haemodynamic goals |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Perioperative inflammatory response, General anesthesia, Toll-Like Receptors