Clinical Trials in Perioperative Medicine

Advances in anesthesia, surgery, and other perioperative practices over recent decades have led to amazing improvements in patient outcomes. Such quality improvement is dependent on evaluation and research. Large-scale studies provide very useful information that can assist in bench-marking, prognostication, and identification of effective interventions. Observational studies have many strengths but also have important limitations. Random assignment to treatment groups minimizes bias, and if the trial is large (e.g., >500 participants), it will balance both known and unknown confounding factors. Large randomized trials are therefore more reliable and because they are typically multicentered (i.e., involving different healthcare settings and clinicians), their results are more generalizable. This chapter explores these aspects and includes some excellent examples of practice-improving clinical trials evaluating perioperative beta-blockade, prevention of postoperative nausea and vomiting, the safety of dexamethasone in noncardiac surgery, and the risks of tight glucose control in critical care. Large pragmatic trials reflect “real-world” patients and clinical settings. They can also measure outcomes that matter to patients, including the potential adverse effects of the intervention. If clinical research in perioperative medicine is to provide more reliable and valid evidence to inform therapeutic decision making in the future, it is clear that a greater proportion of such research needs to be large, high-quality, multicenter randomized trials.