Impact of flumazenil on recovery after outpatient endoscopy: a placebo-controlled trial

Background: Flumazenil is an imidazobenzodiazepine that blocks the central effects of benzodiazepines by competitive interaction at the receptor level . In this study we assessed the impact of flumazenil use on postsedation ob servation time in outpatients undergoing endoscopy. Methods: Sixty outpatients received midazolam for conscious sedation and we re randomized after endoscopy to receive intravenous flumazenil (0.1 mg/mL) or placebo until awake or a total of 10 mL was given. All patients were as sessed using various psychomotor and cognitive tests at baseline and at 5, 15, 30, 45 and 60 minutes after flumazenil or placebo was administered. Results: The two groups were similar in age, gender, midazolam dose (mg/kg) , vital signs, and baseline parameters. The average dose of flumazenil give n was 0.41 mg. Sedation scores returned to presedation levels earlier in th e flumazenil group, with significant differences compared to placebo at 5 m inutes (84.6% vs. 24.2%), 15 minutes (88.5% vs. 57.6%) and 30 minutes (96.2 % vs. 66.7%). Other parameters tested were not significantly different for patients receiving placebo compared to those given flumazenil. Sedation sco res returned to baseline earlier than other psychomotor and cognitive tests in both groups. Flumazenil reduced the mean observation time from 23.5 min utes to 8.3 minutes (p < 0.0005), a difference of 15.2 minutes (64.7%) base d on sedation score. Conclusions: Flumazenil significantly reduces postsedation observation time . Actual cost savings will vary depending on staff end facility capacity, p atient volume, flumazenil cost, and unit cost of observation time.