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Please use this identifier to cite or link to this item: http://hdl.handle.net/11055/562
Title: Nitrous oxide and perioperative cardiac morbidity (ENIGMA-II) Trial: rationale and design.
Authors: Myles, Paul S
Leslie, Kate
Peyton, Philip
Paech, Michael
Forbes, Andrew
Chan, Matthew T V
Sessler, Daniel
Devereaux, Philip J
Silbert, Brendan S
Jamrozik, Konrad
Beattie, Scott
Badner, Neal
Tomlinson, James
Wallace, Sophia
Issue Date: Mar-2009
Citation: American heart journal 2009-03; 157(3): 488-494.e1
Abstract: Globally there are >200 million major surgical procedures undertaken annually, and about 20% of these involve patients who have coronary artery disease. Many receive nitrous oxide, which impairs methionine synthase, thus inhibiting folate synthesis and increasing postoperative homocysteine levels. Nitrous oxide anesthesia leads to postoperative endothelial dysfunction, and there is some evidence that it increases myocardial ischemia and, possibly, myocardial infarction. We have initiated the Nitrous oxide and perioperative cardiac morbidity (ENIGMA-II) Trial to test the hypothesis that in inpatients undergoing anesthesia for major noncardiac surgery, avoidance of nitrous oxide will reduce the incidence of death and major cardiovascular events. ENIGMA-II is a 7,000-patient, international randomized trial involving patients at risk of coronary artery disease undergoing noncardiac surgery. The patients, health care providers (except for the anesthesiologists), data collectors, and outcome adjudicators are blinded to whether patients receive nitrous oxide-containing or nitrous oxide-free anesthetic. The primary outcome is a composite of death and major nonfatal events (ie, myocardial infarction, cardiac arrest, pulmonary embolism, and stroke) at 30 days after surgery. At present, ENIGMA-II has randomized >1,000 patients in 22 hospitals in 5 countries. To date, patients' mean age is 70 years, 66% are men, 38% have a history of coronary artery disease, 19% have a history of cerebrovascular disease, and 84% have a history of hypertension. Most patients have undergone intra-abdominal 28%, vascular 32%, and orthopedic 16% surgery. The ENIGMA-II Trial will be the largest study yet conducted to ascertain the benefits and risks of removing nitrous oxide from the gas mixture in anesthesia. The results of this large international trial will guide the clinical care of the hundreds of millions of adults undergoing noncardiac surgery annually.
URI: http://hdl.handle.net/11055/562
DOI: 10.1016/j.ahj.2008.11.015
PubMed URL: https://www.ncbi.nlm.nih.gov/pubmed/19249419
Journal Title: American heart journal
Type: Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Appears in Collections:Scholarly and Clinical

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