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Completed

NCT Number: NCT00356746

Inflammatory Response During Anesthesia and Surgery

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.

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Key information

Conditions

Systemic Inflammatory Response Syndrome Cardiovascular Diseases Heart Diseases Inflammation Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UMC Utrecht, Division of Perioperative Care and Emergency Medicine, Department of Anesthesiology

Utrecht, 3508 GA, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Collaborators

  • European Association of Cardiothoracic Anaesthesiologists

Registry information

Official study title

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

Acronym: IRAS

Important dates

Study start
2006
Primary completion
2007
Study completion
2009
First posted
Jul 26, 2006
Registry last updated
Jun 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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