Rationale and design of the balanced anesthesia study: A prospective randomized clinical trial of two levels of anesthetic depth on patient outcome after major surgery

Abstract

BACKGROUND: An association between relatively deep anesthesia, as guided by the bispectral index (BIS), and increased postoperative mortality has been demonstrated in 6 of 8 published observational studies, but association does not necessarily mean causality. Small clinical trials of anesthetic depth have demonstrated increased delirium and postoperative cognitive dysfunction in patients who were relatively deeply anesthetized, but have been inadequately powered to study mortality. A large-scale randomized study is required to determine whether causality exists. METHODS: The primary hypothesis of our study is that "light" anesthesia, defined as a BIS target of 50, will reduce all-cause morta..