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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.

Publication ,  Journal Article
Silvestri, GA; Vincent, BD; Wahidi, MM; Robinette, E; Hansbrough, JR; Downie, GH
Published in: Chest
January 2009

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

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Published In

Chest

DOI

EISSN

1931-3543

Publication Date

January 2009

Volume

135

Issue

1

Start / End Page

41 / 47

Location

United States

Related Subject Headings

  • Young Adult
  • Treatment Outcome
  • Respiratory System
  • Propofol
  • Patient Satisfaction
  • Middle Aged
  • Male
  • Injections, Intravenous
  • Hypnotics and Sedatives
  • Humans
 

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Silvestri, G. A., Vincent, B. D., Wahidi, M. M., Robinette, E., Hansbrough, J. R., & Downie, G. H. (2009). 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. Chest, 135(1), 41–47. https://doi.org/10.1378/chest.08-0623
Silvestri, Gerard A., Brad D. Vincent, Momen M. Wahidi, Emory Robinette, James R. Hansbrough, and Gordon H. Downie. “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.Chest 135, no. 1 (January 2009): 41–47. https://doi.org/10.1378/chest.08-0623.
Silvestri, Gerard A., et al. “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.Chest, vol. 135, no. 1, Jan. 2009, pp. 41–47. Pubmed, doi:10.1378/chest.08-0623.

Published In

Chest

DOI

EISSN

1931-3543

Publication Date

January 2009

Volume

135

Issue

1

Start / End Page

41 / 47

Location

United States

Related Subject Headings

  • Young Adult
  • Treatment Outcome
  • Respiratory System
  • Propofol
  • Patient Satisfaction
  • Middle Aged
  • Male
  • Injections, Intravenous
  • Hypnotics and Sedatives
  • Humans