A randomized, double-blind, phase 3 study of fospropofol disodium for sedation during colonoscopy

Lawrence B. Cohen, Edward Cattau, Allen Goetsch, Atul Shah, John R. Weber, Douglas K. Rex, Jacqueline M. Kline

Research output: Contribution to journalArticle

42 Scopus citations

Abstract

Goals: This double-blind, multicenter study evaluated the safety and efficacy of intravenous fospropofol (6.5mg/kg vs. 2mg/kg) for moderate sedation in patients undergoing colonoscopy. Methods: In all, 314 patients 18 years (American Society of Anesthesiologists PS1 to PS3) were randomized to receive fospropofol 2mg/kg, fospropofol 6.5-mg/kg, or midazolam 0.02mg/kg, after pretreatment with intravenous fentanyl 50mcg. Supplemental doses of study medication were permitted to achieve a Modified Observer's Assessment of Alertness/Sedation scale score ≤4 and to enable the investigator to begin a procedure. The study end points included sedation success, recovery, memory retention, physician satisfaction, and safety. Results: Sedation success was higher in the fospropofol 6.5mg/kg versus 2mg/kg group (87% vs. 26%; P<0.001) and was 69% in the midazolam group. Patients in the 6.5-mg/kg group were significantly less likely to remember being awake during the procedure (51% vs. 100% in the 2-mg/kg group, P<0.001; 60% for the midazolam group). Patients in the fospropofol groups had similar memory retention (70% and 82% for the 6.5mg/kg and 2mg/kg groups, respectively) compared with 41% for the midazolam group. Mean physician satisfaction scores were higher in the fospropofol 6.5-mg/kg group (7.7) than the 2-mg/kg group (4.5), P<0.001. Most adverse events were mild to moderate in intensity; the most common treatment-related adverse events were paresthesias (68% vs. 60%) and pruritus (16% vs. 26%) in the fospropofol 6.5 and 2mg/kg groups, respectively. Conclusions: The fospropofol 6.5-mg/kg dosing regimen was well tolerated and effective for sedation during colonoscopy and was associated with higher rates of sedation success, memory retention, and physician satisfaction than the fospropofol 2-mg/kg dose.

Original languageEnglish (US)
Pages (from-to)345-353
Number of pages9
JournalJournal of Clinical Gastroenterology
Volume44
Issue number5
DOIs
StatePublished - May 1 2010

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Keywords

  • Colonoscopy
  • Fospropofol disodium
  • Moderate sedation
  • Randomized clinical trial

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Cohen, L. B., Cattau, E., Goetsch, A., Shah, A., Weber, J. R., Rex, D. K., & Kline, J. M. (2010). A randomized, double-blind, phase 3 study of fospropofol disodium for sedation during colonoscopy. Journal of Clinical Gastroenterology, 44(5), 345-353. https://doi.org/10.1097/MCG.0b013e3181c2987e