A C Chang1, M A Solinger, D T Yang, Y K Chen. 1. Division of Gastroenterology, Department of Medicine, Loma Linda University Medical Center, Loma Linda, California 92350, USA.
Abstract
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 observation time in outpatients undergoing endoscopy. METHODS:Sixty outpatients receivedmidazolam for conscious sedation and were 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 assessed 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 given was 0.41 mg. Sedation scores returned to presedation levels earlier in the flumazenil group, with significant differences compared to placebo at 5 minutes (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 scores returned to baseline earlier than other psychomotor and cognitive tests in both groups. Flumazenil reduced the mean observation time from 23.5 minutes to 8.3 minutes (p < 0.0005), a difference of 15.2 minutes (64.7%) based on sedation score. CONCLUSIONS:Flumazenil significantly reduces postsedation observation time. Actual cost savings will vary depending on staff and facility capacity, patient volume, flumazenil cost, and unit cost of observation time.
RCT Entities:
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 observation time in outpatients undergoing endoscopy. METHODS: Sixty outpatients received midazolam for conscious sedation and were 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 assessed 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 given was 0.41 mg. Sedation scores returned to presedation levels earlier in the flumazenil group, with significant differences compared to placebo at 5 minutes (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 scores returned to baseline earlier than other psychomotor and cognitive tests in both groups. Flumazenil reduced the mean observation time from 23.5 minutes to 8.3 minutes (p < 0.0005), a difference of 15.2 minutes (64.7%) based on sedation score. CONCLUSIONS:Flumazenil significantly reduces postsedation observation time. Actual cost savings will vary depending on staff and facility capacity, patient volume, flumazenil cost, and unit cost of observation time.