Study Objective: To evaluate postoperative renal function after patients we
re administered sevoflurane under conditions designed to generate high conc
entrations of compound A.
Study Design and Setting: A multicenter (11 sites), multinational, open-lab
el, randomized, comparative study of perioperative renal function in patien
ts who have received low-flow (less than or equal to 1 L/min) sevoflurane o
r isoflurane.
Patients: 254 ASA physical status I, II and III patients requiring endotrac
heal intubation for elective surgery lasting more than 2 hours. Interventio
ns: After induction, low-flow anesthesia was initiated at a flow rate less
than or equal to 1 L/min. Blood and urine samples were studied to assess po
stoperative renal function.
Measurements and Main Results: Measurements of serum BUN and creatinine, an
d urine glucose, protein pH and specific gravity were used to assess renal
function preoperatively and up to 3 days postoperatively. Serum inorganic f
luoride ion concentration was measured at preinduction, emergence, and 2, 2
4 and 72 hours postoperatively. Compound A concentrations were measured at
two sites far 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 wer
e significantly higher after sevoflurane (40 +/- 16 mu M) than after isoflu
rane (3 +/- 2 mu M). Serum creatinine and BUN decreased in both groups post
operatively; glucosuria and proteinuria occurred in 15% to 25% of patients.
There were no clinically significant differences in BUN, creatinine, gluco
suria, and proteinuria between the low-flow sevoflurane and low-flow isoflu
rane patients.
Conclusions: There were no statistically significant differences in the ren
al effects of sevoflurane or isoflurane in surgical patients undergoing low
-flow anesthesia for up to 8 hours. I,ow-flow sevoflurane anesthesia under
clinical conditions expected to produce high levels of compound A appears a
s safe as low-flow isoflurane anesthesia. (C) 1999 by Elsevier Science Inc.