The safety of addition of nitrous oxide to general anaesthesia in at-risk patients having major non-cardiac surgery (ENIGMA-II): a randomised, single-blind trial

Publication date: 18–24 October 2014 Source:The Lancet, Volume 384, Issue 9952 Author(s): Paul S Myles , Kate Leslie , Matthew T V Chan , Andrew Forbes , Philip J Peyton , Michael J Paech , W Scott Beattie , Daniel I Sessler , P J Devereaux , Brendan Silbert , Thomas Schricker , Sophie Wallace Background Nitrous oxide is commonly used in general anaesthesia but concerns exist that it might increase perioperative cardiovascular risk. We aimed to gather evidence to establish whether nitrous oxide affects perioperative cardiovascular risk. Methods We did an international, randomised, assessor-blinded trial in patients aged at least 45 years with known or suspected coronary artery disease having major non-cardiac surgery. Patients were randomly assigned via automated telephone service, stratified by site, to receive a general anaesthetic with or without nitrous oxide. Attending anaesthetists were aware of patients' group assignments, but patients and assessors were not. The primary outcome measure was a composite of death and cardiovascular complications (non-fatal myocardial infarction, stroke, pulmonary embolism, or cardiac arrest) within 30 days of surgery. Our modified intention-to-treat population included all patients randomly assigned to groups and undergoing induction of general anaesthesia for surgery. This trial is registered at ClinicalTrials.gov, number NCT00430989. Findings Of 10 102 eligible patients, we enrolled 7112 patients between May 30,...
Source: The Lancet - Category: Journals (General) Source Type: research