Abstract
PURPOSE: This study aimed to compare the electrolyte balance efficacies of two Gelatin-Balanced Crystalloid in clinical applications. METHODS: A multi-center, prospective, randomized, single-blind, parallel controlled study was conducted among non-cardiac surgery patients, with clinical registration number ChiCTR2200062999. They were randomized into Succinylated Gelatin, Multiple Electrolytes and Sodium Acetate Injection (SG-MESAI) group (experimental group) and Succinylated Gelatin Injection (SGI) infusion group (control group). The same anesthetic induction technique, anesthetic method, and calculation method for the volume of colloid infusion were used in the two groups. Between-group differences in the changes in base excess (BE), Chloride ion (Cl(-)), bicarbonate radical (HCO(3)⁻) and other parameters were recorded at 15 min, 30 min after the infusion relative to the baseline. Hemodynamic indicators were determined at 30 min after colloid infusion. Safety follow-up was conducted by administering the following tests within 48 h±12 h after surgery. RESULTS: A total of 225 subjects (full analysis set) were finally enrolled, with 110 subjects in the experimental group and 115 subjects in the control group. The baseline data were comparable between the two groups. At 15 min after infusion, the mean changes in BE, Cl(-) and HCO(3)⁻ concentration in the experimental group were smaller than those of the control group (P<0.001). At 30 min after surgery, the mean changes in BE, Cl(-), HCO(3)⁻concentration and pH value were smaller in the experimental group than in the control group (P<0.05). The incidences of adverse events and adverse reactions in the experimental group was less than the control group, but the difference was not statistically significant (P≥0.05). Besides, no serious adverse events or adverse reactions were reported in any subjects. CONCLUSION: Succinylated Gelatin, Multiple Electrolytes and Sodium Acetate Injection maintained the balance of BE, Cl(-), HCO(3)⁻ and pH value in a better way than Succinylated Gelatin Injection in non-cardiac surgery patients under general anesthesia.