Safety and efficacy of propofol with EDTA when used for sedation of surgical intensive care unit patients

Objective: To compare propofol with disodium edetate (EDTA) and propofol wi thout EDTA when used for the sedation of critically ill surgical intensive care unit (ICU) patients. Design: Prospective, randomised, multicentre trial. Patients: A total of 122 surgical ICU patients who required intubation and mechanical ventilation. Interventions: Patients were randomised to receive either propofol or propo fol plus EDTA (propofol EDTA) by continuous infusion for sedation. Measurements and Results: The addition of EDTA to propofol had no effect on calcium or magnesium homeostasis, renal function, haemodynamic function, o r efficacy when used for the sedation of surgical patients in the ICU. The most common adverse events were hypotension, atrial fibrillation, and hypoc alcaemia. In this trial, a greater number of serious adverse events and adv erse events leading to withdrawal occurred in the propofol group relative t o the propofol EDTA group. There was a significantly lower crude mortality rate at 7 and 28 days for the propofol EDTA group compared with the propofo l group. There were no statistically significant differences between groups with respect to depth of sedation. Conclusion: The propofol EDTA formulation had no effect on calcium or magne sium homeostasis, renal function, or sedation efficacy compared with propof ol alone when used for sedation in critically ill surgical ICU patients. Th ere was a significant decrease in mortality in the propofol EDTA group comp ared with the propofol group. Further investigations are needed to validate this survival benefit and elucidate a possible mechanism.