Clinical assessment of sodium potassium magnesium calcium and glucose injection infused during surgery: a prospective, randomized, single-blind, positive drug controlled, multicentric clinical trial

Objective To compare with sodium lactate Ringer injection, this trial investigated the efficacy and safety of sodium potassium magnesium calcium and glucose injection infused during the surgery. Methods Patients with ASA grade Ⅰ -Ⅱ scheduled for elective general or orthopaedic surgery were randomly assigned to experimental group and control group. Sodium lactate Ringer injection(control group) or sodium potassium magnesium calcium and glucose injection (experimental group) was infused 500ml with the rate 15ml·kg-1·h-1 before the induction,infused with the rate 10 ml·kg-1·h-1 for 2 h after induction,and then infused with the rate 8ml·kg-1·h-1 until the surgery was finished.Routine blood test,renal and hepatic fuction,blood biochemistry test and coagulation function were detected before and after surgery. Hemodynamics parametres, arterial blood gas analysis and blood glucose were measured before infusion, pre-induction, 1 h after induction, 2 h after induction et al until the end of infusion. Results To evaluate the changes of hemodynamics, urine volumes, blood glucose, electrolyte, acid-base balance, the effective rate in the experimental group was 100% and in the control group is 99.53% with no statistically significant difference between two groups. The patients in the experimental group assessed as safety and rough safety were 89.69%(200) and 10.31%(23) respectively and the patients in the control group as safety and rough safety were 91.47% (193) and 8.53% (18) respectively with no statistically significantly difference between two groups. Conclusion Sodium potassium magnesium calcium and glucose injection was infused as the same efficacy and safety as commonly used sodium lactate Ringer injection during the surgery. Key words: Sodium potassium magnesium calcium and glucose injection; Sodium lactate ringer injection; Liquid therapy; Infusion