• World J. Gastroenterol. · Jun 2013

    Randomized Controlled Trial Comparative Study

    Deep sedation during gastrointestinal endoscopy: propofol-fentanyl and midazolam-fentanyl regimens.

    • Marcos Eduardo Lera dos Santos, Fauze Maluf-Filho, Dalton Marques Chaves, Sergio Eiji Matuguma, Edson Ide, Gustavo de Oliveira Luz, Thiago Ferreira de Souza, Fernanda C Simões Pessorrusso, Eduardo Guimarães Hourneaux de Moura, and Paulo Sakai.
    • Department of Gastroenterology, Hospital das Clínicas, University of Sao Paulo Medical School, Sao Paulo, CEP 05403-900, Brazil. marcoslera@gmail.com
    • World J. Gastroenterol. 2013 Jun 14;19(22):3439-46.

    AimTo compare deep sedation with propofol-fentanyl and midazolam-fentanyl regimens during upper gastrointestinal endoscopy.MethodsAfter obtaining approval of the research ethics committee and informed consent, 200 patients were evaluated and referred for upper gastrointestinal endoscopy. Patients were randomized to receive propofol-fentanyl or midazolam-fentanyl (n = 100/group). We assessed the level of sedation using the observer's assessment of alertness/sedation (OAA/S) score and bispectral index (BIS). We evaluated patient and physician satisfaction, as well as the recovery time and complication rates. The statistical analysis was performed using SPSS statistical software and included the Mann-Whitney test, χ² test, measurement of analysis of variance, and the κ statistic.ResultsThe times to induction of sedation, recovery, and discharge were shorter in the propofol-fentanyl group than the midazolam-fentanyl group. According to the OAA/S score, deep sedation events occurred in 25% of the propofol-fentanyl group and 11% of the midazolam-fentanyl group (P = 0.014). Additionally, deep sedation events occurred in 19% of the propofol-fentanyl group and 7% of the midazolam-fentanyl group according to the BIS scale (P = 0.039). There was good concordance between the OAA/S score and BIS for both groups (κ = 0.71 and κ = 0.63, respectively). Oxygen supplementation was required in 42% of the propofol-fentanyl group and 26% of the midazolam-fentanyl group (P = 0.025). The mean time to recovery was 28.82 and 44.13 min in the propofol-fentanyl and midazolam-fentanyl groups, respectively (P < 0.001). There were no severe complications in either group. Although patients were equally satisfied with both drug combinations, physicians were more satisfied with the propofol-fentanyl combination.ConclusionDeep sedation occurred with propofol-fentanyl and midazolam-fentanyl, but was more frequent in the former. Recovery was faster in the propofol-fentanyl group.

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