A phase 3, randomized, double-blind study to assess the efficacy and safety of fospropofol disodium injection for moderate sedation in patients undergoing flexible bronchoscopy.

Journal Article (Clinical Trial, Phase III;Journal Article;Multicenter Study)

BACKGROUND: Fospropofol disodium is a water-soluble prodrug of propofol with unique pharmacokinetic/pharmacodynamic properties. This randomized, double-blind, multicenter study evaluated the use of fospropofol in patients undergoing flexible bronchoscopy. METHODS: Patients >or= 18 years of age were randomized (2:3) to receive fospropofol, 2 mg/kg or 6.5 mg/kg, after pretreatment with fentanyl, 50 microg. Supplemental doses of each were given per protocol. The primary end point was sedation success, which was defined as follows: three consecutive Modified Observer's Assessment of Alertness/Sedation scores of

Full Text

Duke Authors

Cited Authors

  • Silvestri, GA; Vincent, BD; Wahidi, MM; Robinette, E; Hansbrough, JR; Downie, GH

Published Date

  • January 2009

Published In

Volume / Issue

  • 135 / 1

Start / End Page

  • 41 - 47

PubMed ID

  • 18641105

Electronic International Standard Serial Number (EISSN)

  • 1931-3543

Digital Object Identifier (DOI)

  • 10.1378/chest.08-0623


  • eng

Conference Location

  • United States