Midazolam for continuous sedation in Japanese critical care patients: Phase II study

This prospective study was undertaken to evaluate the efficacy and safety o f midazolam as a sedative agent in 14 critically ill patients without coma admitted to the intensive care unit at Nihon University Itabashi Hospital, Japan. Adequate sedation (sedation score [SS] 4 - 6) was induced with 0.058 - 0.372 mg/ kg midazolam and maintained with a dose range of 0.03 - 0.4 mg /kg per h. Most burn or trauma patients required higher midazolam doses tha n patients with cardiovascular disease. The most frequent adverse events ob served were hypotension, heart-rate fluctuation and electrocardiogram abnor malities. Pharmacokinetic analysis of the population suggested that lower d rug clearance rates correlated with presence of complications. Plasma conce ntrations (EC50) of SS 5, estimated by logistic regression analysis, varied among patients (mean 194 ng/ml). Midazolam infusion achieved successful se dation in this critical care setting, but the optimum dose differed by pati ent and was influenced by the presence of complications.