title: Balanced propofol sedation versus propofol monosedation in therapeutic pancreaticobiliary endoscopic procedures.
abstract: 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.
  
  
  OBJECTIVE
  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.affiliation: 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
authors.forename: Tae Hoon
authors.initials: TH
authors.lastname: Lee
authors.forename: Chang Kyun
authors.initials: CK
authors.lastname: Lee
authors.forename: Sang-Heum
authors.initials: SH
authors.lastname: Park
authors.forename: Suck-Ho
authors.initials: SH
authors.lastname: Lee
authors.forename: Il-Kwun
authors.initials: IK
authors.lastname: Chung
authors.forename: Hyun Jong
authors.initials: HJ
authors.lastname: Choi
authors.forename: Sang Woo
authors.initials: SW
authors.lastname: Cha
authors.forename: Jong Ho
authors.initials: JH
authors.lastname: Moon
authors.forename: Young Deok
authors.initials: YD
authors.lastname: Cho
authors.forename: Young
authors.initials: Y
authors.lastname: Hwangbo
authors.forename: Sun-Joo
authors.initials: SJ
authors.lastname: Kim
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D018686:Anesthetics, Intravenous / Q000008:administration & dosage; D002760:Cholangiopancreatography, Endoscopic Retrograde; D004311:Double-Blind Method; D005260:Female; D005283:Fentanyl / Q000008:administration & dosage; D006801:Humans; D006993:Hypnotics and Sedatives / Q000008:administration & dosage* / Q000009:adverse effects / Q000191:economics; D008297:Male; D008874:Midazolam / Q000008:administration & dosage; D008875:Middle Aged; D015742:Propofol / Q000008:administration & dosage* / Q000009:adverse effects / Q000191:economics; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D018686:Anesthetics, Intravenous; D006993:Hypnotics and Sedatives; D008874:Midazolam; D005283:Fentanyl; D015742:Propofol