Comparison of HES 130/0.4 and acetate Ringer′s solution versus HES 130/0.4 and normal saline for volume therapy in patients undergoing non-cardiac surgery with general anesthesia: a randomized, blinded, parallel-controlled, multicenter clinical trial / 中华麻醉学杂志

ABSTRACT

Objective:To compare the efficacy of HES 130/0.4 and acetate Ringer′s solution (A-HES) and HES 130/0.4 and normal saline (NS-HES) for volume therapy in the patients undergoing non-cardiac surgery with general anesthesia.Methods:Two hundred and fifty American Society of Anesthesiologist physical status Ⅰ or Ⅱ patients of both sexes, aged 18-64 yr, with body mass index of 18-32 kg/m 2, undergoing noncardiac surgery with general anesthesia, were divided into group A-HES and group NS-HES using the stratified block randomization technique.A-HES and NS-HES 15 ml/kg were intravenously infused over 1 h immediately after induction of anesthesia in A-HES and NS-HES groups, respectively.Mean arterial pressure (MAP), heart rate (HR) and central venous pressure (CVP) were recorded before and after infusion, and the maximum changing rate of MAP and HR and the maximum change in CVP were calculated.The pH value, BE and HCO 3- were recorded before infusion and at 15 min after the end of infusion, and Hb, Hct, electrolytes, blood glucose, blood biochemical parameters and parameters of coagulation function were measured.The occurrence of abnormal blood biochemical parameters, blood glucose, and parameters of coagulation function, intraoperative requirement for vasoactive drugs, occurrence of HES-related adverse events, and intraoperative fluid intake and output were recorded. Results:A total of 251 cases were actually enrolled in this study, with 125 cases in group A-HES, and 126 cases in group NS-HES.Compared with group NS-HES, no significant change was found in the maximum changing rate of MAP and HR and the maximum change in CVP ( P>0.05) in group A-HES, and non-inferiority analysis showed that group A-HES was not inferior to group NS-HES.Compared with group NS-HES, the concentrations of BE and HCO 3-, K + , Ca 2+ and Mg 2+ were significantly increased, the concentrations of Na + and Cl - were decreased, the PT was shortened, the incidence of abnormal PT was decreased at 15 min after the end of infusion ( P< 0.05), and no significant change was found in the other parameters mentioned above in group A-HES ( P>0.05). Conclusion:The volume expanding effect of A-HES and its effect on liver and kidney function are not significantly different from those of NS-HES, however, A-HES has certain advantages in maintaining acid-base balance, electrolyte stability and coagulation function.