Early Use of Norepinephrine in High-risk Patients Undergoing Major Abdominal Surgery: A Randomized Controlled Trial
Abstract
Background: Intraoperative hypotension is a strong predictor of adverse outcomes in major abdominal surgery. However, data on the occurrence of intraoperative hypotension during the induction of general anesthesia are scarce. We hypothesized that early prevention of postinduction hypotension using a vasopressor could reduce postoperative adverse outcomes. Methods: In this single-center randomized trial at Amiens Hospital University (Amiens, France), adults older than 50 yr with American Society of Anesthesiologists (Schaumburg, Illinois) Physical Status II or greater undergoing major abdominal surgery were assigned to ephedrine or norepinephrine groups. In the ephedrine group, titration with iterative boluses of ephedrine (3 mg · ml-1) was performed at the induction if intraoperative hypotension occurred. In the norepinephrine group, continuous intravenous injection of norepinephrine (0.016 mg · ml-1) was started at a rate of 0.48 mg · h-1 from the induction of anesthesia and was titrated if intraoperative hypotension occurred. The primary endpoint was any medico-surgical complication within 30 days (Clavien–Dindo score of 1 or greater). Secondary endpoints included hospital stay length, acute kidney injury, 1-month mortality, and cardiovascular, respiratory, neurologic, and infectious complications. Results were assessed by blinded evaluators. Results: A total of 500 patients were randomized, and 473 were included in the intention-to-treat analysis. The cumulative episodes…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 500 participants or records.
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