A randomized, double-blind, phase 3 study of fospropofol disodium for sedation during colonoscopy.
OBJECTIVE
This double-blind, multicenter study evaluated the safety and efficacy of intravenous fospropofol (6.5 mg/kg vs. 2 mg/kg) for moderate sedation in patients undergoing colonoscopy.


METHODS
In all, 314 patients >or=18 years (American Society of Anesthesiologists PS1 to PS3) were randomized to receive fospropofol 2 mg/kg, fospropofol 6.5- mg/kg, or midazolam 0.02 mg/kg, after pretreatment with intravenous fentanyl 50 mcg. Supplemental doses of study medication were permitted to achieve a Modified Observer's Assessment of Alertness/Sedation scale score <or=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 6.5 mg/kg versus 2 mg/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 6.5 mg/kg and 2 mg/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 2 mg/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.
Cohen
Lawrence B
LB
Department of Medicine, The Mount Sinai Hospital, New York, NY 10021, USA. lawrence.cohen@nyga.md
Cattau
Edward
E
Goetsch
Allen
A
Shah
Atul
A
Weber
John R
JR
Rex
Douglas K
DK
Kline
Jacqueline M
JM
D000328:Adult; D000368:Aged; D000762:Anesthesia Recovery Period; D018686:Anesthetics, Intravenous / Q000627:therapeutic use; D003113:Colonoscopy / Q000379:methods*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005283:Fentanyl / Q000627:therapeutic use; D006801:Humans; D006993:Hypnotics and Sedatives / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008568:Memory / Q000187:drug effects; D008874:Midazolam / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D015742:Propofol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome
D018686:Anesthetics, Intravenous; D006993:Hypnotics and Sedatives; C472965:fospropofol; D008874:Midazolam; D005283:Fentanyl; D015742:Propofol