• Gastrointest. Endosc. · Jan 2011

    Randomized Controlled Trial Comparative Study

    Sedation during upper GI endoscopy in cirrhotic outpatients: a randomized, controlled trial comparing propofol and fentanyl with midazolam and fentanyl.

    • Lucianna Motta Correia, Danielle Queiroz Bonilha, Gustavo Flores Gomes, Juliana Ramos Brito, Frank Shigueo Nakao, Luciano Lenz, Maria Rachel Silveira Rohr, Angelo P Ferrari, and Ermelindo Della Libera.
    • Disciplina de Gastroenterologia Clínica, Universidade Federal de São Paulo, São Paulo, Brasil.
    • Gastrointest. Endosc. 2011 Jan 1;73(1):45-51, 51.e1.

    BackgroundPatients with liver cirrhosis frequently undergo diagnostic or therapeutic upper GI endoscopy (UGIE), and the liver disease might impair the metabolism of drugs usually administered for sedation.Objective And SettingTo compare sedation with a combination of propofol plus fentanyl and midazolam plus fentanyl in cirrhotic outpatients undergoing UGIE.DesignA prospective, randomized, controlled trial was conducted between February 2008 and February 2009.Main Outcomes MeasurementsEfficacy (proportion of complete procedures using the initial proposed sedation scheme), safety (occurrence of sedation-related complications), and recovery time were measured.ResultsTwo hundred ten cirrhotic patients referred for UGIE were randomized to 2 groups: midazolam group (0.05 mg/kg plus fentanyl 50 μg intravenously) or propofol group (0.25 mg/kg plus fentanyl 50 μg intravenously). There were no differences between groups regarding age, sex, weight, etiology of cirrhosis, and Child-Pugh or American Society of Anesthesiologists classification. Sedation with propofol was more efficacious (100% vs 88.2%; P < .001) and had a shorter recovery time than sedation with midazolam (16.23 ± 6.84 minutes and 27.40 ± 17.19 minutes, respectively; P < .001). Complication rates were similar in both groups (14% vs 7.3%; P = .172).LimitationsSingle-blind study; sample size.ConclusionBoth sedation schemes were safe in this setting. Sedation with propofol plus fentanyl was more efficacious with a shorter recovery time compared with midazolam plus fentanyl. Therefore, the former scheme is an alternative when sedating cirrhotic patients undergoing UGIE.Copyright © 2011 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

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