Anesthesia Clinical Trials Session
Sunday, 1:10-3:10 p.m.
Upper Level 20A

James C. Eisenach, M.D.

ASA is unveiling three major clinical trials Sunday with simultaneous publication in major medical journals. This is the first year the Society is presenting key results on the day of publication.

“We have been waiting for these results for years,” said James C. Eisenach, M.D., Professor of Anesthesiology at Wake Forest University School of Medicine and Editor-in-Chief of the journal Anesthesiology. “These trials will answer major questions the anesthesia community has posed.” He is moderator of tomorrow’s “Anesthesia Clinical Trials Session” from 1:10 to 3:10 p.m.

Appearing in Anesthesiology

“Nitrous Oxide and Serious Long-term Morbidity and Mortality in the Elimination of Nitrous Oxide in the Gas Mixture for Anesthesia II (ENIGMA-II)” compares the effects on one-year mortality of 70-percent nitrous oxide versus 70-percent nitrogen with 30-percent oxygen. ENIGMA-I, published in 2014, found that nitrous oxide had no effect on 30-day outcomes following elective surgery.

“People don’t often die in the operating room, but if you look one year out, surgery can be a pretty risky thing for patients having major surgery, especially those with comorbidities,” Dr. Eisenach said. “Knowing what, if any, effect nitrous oxide has on outcomes is an important question.”

So is the potential effect of corticosteroids on chronic pain. “Methylprednisolone Does Not Reduce Persistent Pain After Cardiac Surgery” examines the effect of high-dose steroids on chronic pain following cardiac surgery. An earlier analysis of the more than 1,000 patients found no effect on rates of myocardial infarction or death following cardiac surgery.

“About one patient in six has persistent pain following cardiac surgery,” Dr. Eisenach noted. “This study address a fairly common problem that too many people are unaware of.”

Appearing in The Lancet

One of the hottest debates in anesthesiology revolves around whether anesthesia and surgery in infants results in developmental toxicity. “Neurodevelopmental Outcome at 2 Years of Age After General and Awake Regional Anaesthesia in Infancy: Results from the GAS Trial” provides an initial answer. Results of the trial also will be published in The Lancet.

“This is the first large, prospective study asking whether anesthesia alters cognitive development in humans,” Dr. Eisenach said. “This question has generated a lot of angst. A total of 660 infants undergoing hernia repair were randomized to general or regional anesthesia with the primary outcome being their scores on the Wechsler Preschool and Primary School Scale of Intelligence. In this session, we will hear for the first time the results at two years after surgery.”