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Flumazenil for Reversing Sedation?

ED protocols often require a period of observation after patients are sedated. These investigators postulated that the use of flumazenil would allow patients to recover faster from conscious sedation. In a multicenter, double-blind trial, they randomized 179 patients to flumazenil or placebo in a 3 to 1 ratio.

All patients were undergoing a short, painful procedure expected to last less than 20 minutes and were sedated with fentanyl (2 µg/kg) followed by midazolam in titrated doses. After the procedure, they received flumazenil (0.2 mg) or placebo in 2 ml of solution to a maximum of 10 ml (1.0 mg flumazenil) and were observed for at least 45 minutes. Demographics, procedures performed, and mean midazolam dose were comparable in the two groups.

Based on a scale created for this study, the flumazenil group returned to baseline alertness an average of 13.7 minutes sooner than the placebo group. However, the time from completion of the procedure to release from the ED was the same (98 vs. 97 minutes). Side effects (all minor) and patient and physician satisfaction were comparable.

Comment: Although these findings imply that flumazenil hastens alertness in patients receiving fentanyl and midazolam, beware. The only difference between patient groups was the "return to alertness" time on an unvalidated scale. Total ED time, which determines cost and resource demand, was identical in the groups, as was satisfaction. Moreover, this manufacturer-supported study should not be extrapolated to sedation with longer-acting benzodiazepines or combinations of opioids in higher doses than those used here.

— DM Birnbaumer

Published in Journal Watch Emergency Medicine December 1, 1997

Citation(s):

Chudnofsky CR et al. Safety and efficacy of flumazenil in reversing conscious sedation in the emergency department. Acad Emerg Med 1997 Oct 4 944-949.

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