BACKGROUND: Prolonged 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. AIM: This 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. METHODS: BPS, 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. RESULTS: There 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. CONCLUSIONS:Propofol 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.
RCT Entities:
BACKGROUND: Prolonged 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. AIM: This 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. METHODS:BPS, 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. RESULTS: There 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. CONCLUSIONS:Propofol 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.
Authors: Gregory A Coté; Christine E Hovis; Richard M Hovis; Lawrence Waldbaum; Dayna S Early; Steven A Edmundowicz; Riad R Azar; Daniel K Mullady; Sreenivasa S Jonnalagadda Journal: Clin Gastroenterol Hepatol Date: 2010-05-23 Impact factor: 11.382