Inflammatory Response During Anesthesia and Surgery (IRAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00356746
Recruitment Status : Completed
First Posted : July 26, 2006
Last Update Posted : June 24, 2015
European Association of Cardiothoracic Anaesthesiologists
Information provided by:
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.

Condition or disease
Systemic Inflammatory Response Syndrome Myocardial Ischemia

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 Type : Observational
Actual Enrollment : 120 participants
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
Study Start Date : March 2006
Actual Primary Completion Date : December 2007
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

elective CABG only patients
elective ICD replacement surgical patients requiring general anesthesia

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Parameters of systemic haemodynamics [ Time Frame: 72 hours ]
  2. Need of vasoactive medication to develop predefined haemodynamic goals [ Time Frame: 72 hours ]
  3. 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 ]
  4. Serious adverse events assessed 3 days after surgery, at discharge, 30 days and one year after surgery [ Time Frame: 1 year ]

Biospecimen Retention:   Samples Without DNA
Full blood smaples

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

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
First Posted: July 26, 2006    Key Record Dates
Last Update Posted: June 24, 2015
Last Verified: June 2008

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

Additional relevant MeSH terms:
Myocardial Ischemia
Coronary Artery Disease
Systemic Inflammatory Response Syndrome
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arterial Occlusive Diseases
Central Nervous System Depressants
Physiological Effects of Drugs