Anesthesia and Outcome after Neonatal Surgery

Abstract
SEVERAL studies in young rodents and primates have identified anesthetic-induced neuronal cell death.1 There is also evidence that surgery in some human infant populations is associated with poor neurodevelopment outcome.2,3 The relevance of these findings to clinical anesthetic practice is an important and controversial question—a question unlikely to be answered with a single study. To address this issue, various studies with various designs have been proposed. In this editorial, we describe a randomized trial that we and colleagues are conducting. Randomized trials provide strong clinical evidence but are not without limitations and challenges. These include the ethics of randomization, choice of comparison group, choice of relevant dose in the treatment arm, definition of suitable outcome measure, and protocol adherence. By describing this trial, we illustrate not only the advantages and rationale for randomized trials, but also some of the problems in general for such trials in infant populations.