Inflammatory Response During Anesthesia and Surgery (IRAS)

This study has been completed.
European Association of Cardiothoracic Anaesthesiologists
Information provided by:
UMC Utrecht Identifier:
First received: July 24, 2006
Last updated: June 23, 2015
Last verified: June 2008
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
Myocardial Ischemia

Study Type: Observational
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

Resource links provided by NLM:

Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Parameters of systemic haemodynamics [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • Need of vasoactive medication to develop predefined haemodynamic goals [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Serious adverse events assessed 3 days after surgery, at discharge, 30 days and one year after surgery [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA
Full blood smaples

Enrollment: 120
Study Start Date: March 2006
Study Completion Date: March 2009
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
elective CABG only patients
elective ICD replacement surgical patients requiring general anesthesia

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
specific surgical patients receiving general anesthesia of university teaching hospital

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00356746

UMC Utrecht, Division of Perioperative Care and Emergency Medicine, Department of Anesthesiology
Utrecht, Netherlands, 3508 GA
Sponsors and Collaborators
UMC Utrecht
European Association of Cardiothoracic Anaesthesiologists
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
  More Information

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: WF Buhre, UMC Utrecht, Department of Anesthesiology Identifier: NCT00356746     History of Changes
Other Study ID Numbers: METC-05/261-E 
Study First Received: July 24, 2006
Last Updated: June 23, 2015
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by UMC Utrecht:
Perioperative inflammatory response
General anesthesia
Toll-Like Receptors

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Systemic Inflammatory Response Syndrome
Arterial Occlusive Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Pathologic Processes
Vascular Diseases processed this record on February 11, 2016