Inflammatory Response During Anesthesia and Surgery

Completed

• Conditions: Systemic Inflammatory Response Syndrome; Myocardial Ischemia

• Registration Number: NCT00356746
• Lead Sponsor: UMC Utrecht

Brief Summary

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

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.

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-07-24
• Study First Submitted QC: 2006-07-24
• Study First Posted: 2006-07-26
• Primary Completion: 2007-12
• Status Verified: 2008-06
• Study Completion: 2009-03
• Last Update Submitted: 2015-06-23
• Last Update Posted: 2015-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

UMC Utrecht, Division of Perioperative Care and Emergency Medicine, Department of Anesthesiology; 🇳🇱 Utrecht, Netherlands