title: Prospective, randomized, placebo-controlled trial evaluating the efficacy and safety of propofol sedation by anesthesiologists and gastroenterologist-led teams using computer-assisted personalized sedation during upper and lower gastrointestinal endoscopy.
abstract: OBJECTIVE
  No randomized controlled studies comparing propofol versus no sedation have been reported. Comparative data demonstrating the efficacy and safety of propofol sedation by anesthesiologists (ANES), and gastroenterologist-led teams (GLT) using computer-assisted personalized sedation (CAPS), during routine gastrointestinal (GI) endoscopy in Japan do not exist. We aimed to demonstrate the safety and efficacy of propofol sedation versus no sedation (PLCB) when propofol is given by ANES or GLT, during routine GI endoscopy.
  
  
  METHODS
  Two hundred and seventy two American Society of Anesthesiologists (ASA) class I or II adults were prospectively enrolled in this multicenter study and randomized into three groups (PLCB, ANES, GLT). Ability to maintain moderate sedation, defined as MOAA/S scores of 2-4 for ≥50% of all MOAA/S measurements from scope-in to scope-out, was the primary endpoint. Secondary endpoints included patient (PSSI) and clinician (CSSI) satisfaction.
  
  
  RESULTS
  Proportion of subjects maintained in moderate sedation by ANES (88.1%) and GLT (94.5%) was significantly higher than PLCB (21.6%; P < 0.001); there was no difference between the ANES and GLT groups (P = 0.116). Mean PSSI scores for subjects sedated by ANES (81.2 ± 12.5) and GLT (80.8 ± 14.1) were significantly higher than PLCB (65.3 ± 19.7; P < 0.001) and mean CSSI scores were also significantly higher in both active treatment groups (75.5 ± 10.2, 77.9 ± 10.3) than PLCB (60.8 ± 18.6; P < 0.001).
  
  
  CONCLUSIONS
  Moderate sedation can be achieved and maintained with propofol, improving both patient and physician satisfaction, when propofol is given by an anesthesiologist or a gastroenterologist-led team using CAPS.
authors.affiliation: Center for Diagnostic and Therapeutic Endoscopy, School of Medicine, Keio University, Tokyo, Japan.
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Kashiwagi
authors.affiliation: Center for Diagnostic and Therapeutic Endoscopy, School of Medicine, Keio University, Tokyo, Japan.
authors.forename: Naoki
authors.initials: N
authors.lastname: Hosoe
authors.affiliation: Matsushima Clinic Coloproctology Center Matsushima Hospital, Yokohama-city, Japan.
authors.forename: Keiji
authors.initials: K
authors.lastname: Takahashi
authors.affiliation: Matsushima Clinic Coloproctology Center Matsushima Hospital, Yokohama-city, Japan.
authors.forename: Haruo
authors.initials: H
authors.lastname: Nishino
authors.affiliation: Digestive Disease Center, Showa University Northern Yokohama Hospital, Yokohama-city, Yokohama, Japan.
authors.forename: Hideyuki
authors.initials: H
authors.lastname: Miyachi
authors.affiliation: Digestive Disease Center, Showa University Northern Yokohama Hospital, Yokohama-city, Yokohama, Japan.
authors.forename: Shin-Ei
authors.initials: SE
authors.lastname: Kudo
authors.affiliation: Ethicon Endo-Surgery, Inc., Cincinnati, USA.
authors.forename: James F
authors.initials: JF
authors.lastname: Martin
authors.affiliation: Center for Diagnostic and Therapeutic Endoscopy, School of Medicine, Keio University, Tokyo, Japan.
authors.forename: Haruhiko
authors.initials: H
authors.lastname: Ogata
mesh_terms: D000328:Adult; D000072080:Anesthesiologists; D016292:Procedural Sedation; D016099:Endoscopy, Gastrointestinal; D005260:Female; D000072102:Gastroenterologists; D006801:Humans; D006993:Hypnotics and Sedatives / Q000627:therapeutic use*; D007564:Japan; D008297:Male; D015742:Propofol / Q000627:therapeutic use*; D011446:Prospective Studies
chemical_list: D006993:Hypnotics and Sedatives; D015742:Propofol
keywords: Endoscopy; moderate sedation; propofol