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 GA, Vincent BD, Wahidi MM, Robinette E, Hansbrough JR, Downie GH. 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. 2009 Jan;135(1):41–7.
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.
Silvestri GA, Vincent BD, Wahidi MM, Robinette E, Hansbrough JR, Downie GH. 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. 2009 Jan;135(1):41–47.
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