• Dig. Dis. Sci. · Aug 2012

    Randomized Controlled Trial Comparative Study

    Balanced propofol sedation versus propofol monosedation in therapeutic pancreaticobiliary endoscopic procedures.

    • Tae Hoon Lee, Chang Kyun Lee, Sang-Heum Park, Suck-Ho Lee, Il-Kwun Chung, Hyun Jong Choi, Sang Woo Cha, Jong Ho Moon, Young Deok Cho, Young Hwangbo, and Sun-Joo Kim.
    • Division of Gastroenterology, Department of Internal Medicine, Soonchunhyang University School of Medicine, Cheonan Hospital, 23-20 Bongmyung-dong, Cheonan-si, Chungcheongnam-do 330-721, Republic of Korea. thlee9@lycos.co.kr
    • Dig. Dis. Sci. 2012 Aug 1;57(8):2113-21.

    BackgroundProlonged or complex endoscopic procedures are frequently performed under deep sedation. However, no studies of therapeutic ERCP have yet compared the use of balanced propofol sedation (BPS) to propofol alone, titrated to moderate levels of sedation.AimThis prospective, randomized, double-blind study was planned to compare the sedation efficacy and safety of BPS (propofol in combination with midazolam and fentanyl) and propofol monosedation in therapeutic ERCP and EUS.MethodsBPS, or propofol monosedation titrated to a moderate level of sedation, was performed by trained registered nurses under endoscopist supervision. The main outcome measurements included sedation efficacy focusing on recovery time, sedation safety, endoscopic procedure outcomes, and complications.ResultsThere were no significant differences in sedation efficacy, safety, procedure outcomes, and complications, with the exception of recovery time. Mean recovery time (standard deviation) was 18.37 (7.86) min in BPS and 13.4 (6.24) min in propofol monosedation (P < 0.001). In a safety analysis, cardiopulmonary complication rates related to BPS and propofol monosedation were 7.8 % (8/102) and 9.6 % (10/104), respectively (P = 0.652). No patient required assisted ventilation or permanent termination of a procedure in either group. Technical success of the endoscopic procedures was 96.3 and 97.2 %, respectively (P = 0.701). Endoscopic procedure-related complications and outcomes did not differ depending on sedation procedure.ConclusionsPropofol monosedation by trained, registered sedation nurses under supervision resulted in a more rapid recovery time than BPS. There were no differences in the sedation safety, endoscopic procedure outcomes, and complications between BPS and propofol monosedation.

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