Study objective: To evaluate postoperative renal function after patients were administered sevoflurane under conditions designed to generate high concentrations of compound A.
Study design and setting: A multicenter (11 sites), multinational, open-label, randomized, comparative study of perioperative renal function in patients who have received low-flow (< or = 1 L/min) sevoflurane or isoflurane.
Patients: 254 ASA physical status I, II and III patients requiring endotracheal intubation for elective surgery lasting more than 2 hours.
Interventions: After induction, low-flow anesthesia was initiated at a flow rate < or = 1 L/min. Blood and urine samples were studied to assess postoperative renal function.
Measurements and main results: Measurements of serum BUN and creatinine, and urine glucose, protein, pH, and specific gravity were used to assess renal function preoperatively and up to 3 days postoperatively. Serum inorganic fluoride ion concentration was measured at preinduction, emergence, and 2, 24 and 72 hours postoperatively. Compound A concentrations were measured at two sites for those patients receiving sevoflurane. Adverse experience data were analyzed. One hundred eighty-eight patients were considered evaluable (98 sevoflurane and 90 isoflurane). Peak serum fluoride concentrations were significantly higher after sevoflurane (40 +/- 16 microM) than after isoflurane (3 +/- 2 microM). Serum creatinine and BUN decreased in both groups postoperatively; glucosuria and proteinuria occurred in 15% to 25% of patients. There were no clinically significant differences in BUN, creatinine, glucosuria, and proteinuria between the low-flow sevoflurane and low-flow isoflurane patients.
Conclusions: There were no statistically significant differences in the renal effects of sevoflurane or isoflurane in surgical patients undergoing low-flow anesthesia for up to 8 hours. Low-flow sevoflurane anesthesia under clinical conditions expected to produce high levels of compound A appears as safe as low-flow isoflurane anesthesia.