COMPARATIVE-STUDY OF PROPOFOL VERSUS MIDAZOLAM IN THE SEDATION OF CRITICALLY-ILL PATIENTS - RESULTS OF A PROSPECTIVE, RANDOMIZED, MULTICENTER TRIAL

Objectives: To compare the effectiveness, characteristics, duration of action, hemodynamic and biochemical effects, and side effects of prop ofol and midazolam used for continuous intravenous sedation of ventila ted critically ill patients. Design: Multicenter, prospective, randomi zed, nonblinded study. Patients: Ninety-eight patients admitted to the ICU who were mechanically ventilated and required sedation for a mini mum of 48 hrs. Interventions: Propofol or midazolam was used for induc tion and maintenance of continuous intravenous sedation for a maximum of 5 days. The effectiveness of those two regimens was assessed accord ing to their effects on ventilatory management and the presence of agi tation. Measurements and Main Results: In 93% of the patients studied, there was a medical cause necessitating mechanical ventilation. The m ean (+/- SD) duration of sedation was 81 +/- 25 hrs and 88 +/- 27 hrs for the propofol and midazolam groups, respectively. The induction dos e was 2.24 +/- 0.43 mg/kg over 318 +/- 363 sees for propofol, and 0.22 +/- 0.07 mg/kg over 33 + 29 sees for midazolam. The maintenance dose was 2.8 +/- 1.1 mg/kg/hr for propofol, and 0.14 +/- 0.10 mg/kg/hr for midazolam. There was no difference regarding the opiate and muscle rel axant requirements between the two groups. Sedation with propofol was more effective in achieving patient-ventilator synchrony than that wit h midazolam after the first hour of treatment (p < .01). patients seda ted with propofol awoke more rapidly and with less variability than th ose patients sedated with midazolam (23 +/- 16 mins vs. 137 +/- 185 mi ns, respectively, p < .05), particularly in those patients requiring d eep sedation (27 +/- 16 mins vs. 237 +/- 222 mins, respectively, p < . 01). No hemodynamic or biochemical changes were detected in any of the treatment groups. During induction, five patients in the propofol gro up and two patients in the midazolam group had hypotension. Conclusion s: in this population of critically ill patients, propofol is an effec tive and safe alternative for sedation, with some advantages, such as short duration of action and high effectiveness, ever the conventional regimen with benzodiazepines and opiates.