Inflammatory Response During Anesthesia and Surgery (IRAS)

UMC Utrecht

Status: Completed

Conditions: Myocardial Ischemia; Systemic Inflammatory Response Syndrome

Study type: Observational

Funder types: Other

Identifiers

NCT00356746

METC-05/261-E

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

120 participants in 2 patient groups

1

Description:

elective CABG only patients

2

Description:

elective ICD replacement surgical patients requiring general anesthesia