1 / 11

Fospropofol for sedation

Fospropofol for sedation. Chris More, SRNA Jeff Varga, SRNA. Properties. Water soluble prodrug of propofol Sedative/hypnotic agent Indications: MAC/sedation in adults undergoing diagnostic or therapeutic procedures. Pharmacology. Pharmacologically inactive Hydrolyzed to propofol

marlow
Download Presentation

Fospropofol for sedation

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Fospropofol for sedation Chris More, SRNA Jeff Varga, SRNA

  2. Properties • Water soluble prodrug of propofol • Sedative/hypnotic agent • Indications: • MAC/sedation in adults undergoing diagnostic or therapeutic procedures

  3. Pharmacology • Pharmacologically inactive • Hydrolyzed to propofol • GABA-ergic • Fospropofol 1.86mg = Propofol 1mg • Sedation-hypnotic effects indistinguishable from propofol except: • More gradual onset • Longer duration

  4. Dosing • Initial dose: 6.5mg/kg • Onset: 40 seconds • Peak effect: 3-15 minutes • Duration: 20-45 minutes • Supplemental dose: 1.5mg/kg • Frequency: 4 minutes • Modified Dosing (>65yo or ASA 3-4): • Initial: 5mg/kg • Supplemental: 1mg/kg every 4 minutes

  5. Advantages • Less pain at injection site • Less hyperlipidemia with long term administration • Reduced risk of bacteremia

  6. Disadvantages • Paresthesia in perianal and perineal areas • Pruritis • Hypoxemia and hypotension • Currently no research on cost analysis comparing fospropofol, propofol, versed

  7. Research • Sedation for Colonoscopy (Cohen et al.) • 314 patients >18 years (ASA I-III) 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 • 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)

  8. Research • Sedation for Bronchoscopy (Silvestri et al.) • 252 patients, 150 were randomized to receive 6.5 mg/kg fospropofol; 102 were randomized to receive 2 mg/kg fospropofol • Results • Sedation success rates were 88.7% and 27.5%, respectively (p < 0.0001). Treatment success (91.3% vs 41.2%, respectively; p < 0.001), willingness to be treated again (94.6% vs 78.2%, respectively; p < 0.001), and absence of procedural recall (83.3% vs 55.4%, respectively; p < 0.001) were significantly better with the administration of 6.5 mg/kg fospropofol • median time to full alertness was slightly longer for the 6.5 mg/kg dose (5.5 vs 3.0 min, respectively).

  9. Research – Safety Evaluation • Sedation for minor surgical procedures (Gan et al.) • 123 patients ≥18 years (ASA I-IV) • Arthroscopy, AV shunt placement, bunionectomy, D & C, EGD, lithotripsy, TEE, and ureteroscopy. • Pretreatment with fentanyl 50 μg • Initial bolus dose of fospropofol 6.5 mg/kg • Supplemental doses of 1.63 mg/kg • Procedural duration 4 mins – 45 mins • Results • Need for alternative sedative medications during the procedure low (4.9% of pts) • Adverse events: • Paresthesia (n = 77, 62.6%) • Pruritus (n = 34, 27.6%) • Hypotension (n = 4, 3.25%) • Bradycardia (n = 1, 0.8%) • Hypoxemia (n = 1, 0.8%) • Fospropofol at an initial dose of 6.5 mg/kg is easily titrated to a target level of sedation for brief diagnostic and therapeutic procedures, and is associated with an acceptable safety and tolerability profile

  10. Summary • Safe • Effective for minor surgical procedures • Requires patience! • Further research needed • Experiences?

  11. References • Cohen, L.B., Cattau, E., Goetsch, A., et al. A random, double-blind, phase 3 study of fospropofol disodium for sedation during colonoscopy. Journal of Clinical Gastroenterology, 2010;44:345–353 • Gan, T.J., Berry, B.D., Ekman, E.F., et al. Safety evaluation of fospropofol for sedation during minor surgical procedures. Journal of clinical anesthesia, 2010;22:260-270 • Garnock-Jones, K. P., & Scott, L. J. (2010). Fospropofol. Drugs, 70 (4), 469-477 • Leslie, J. B. (2010). Fospropofol (lusedra) may be an alternative to propofol for monitored anesthesia. Anesthesia patient safety foundation newsletter, 25 (2), 21-44. • Silvestri GA, Vincent BD, Wahidi MM, 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 2009 Jan; 135 (1): 41-7 • US FDA. Center for drug evaluation and research summary review for application number 22-244, (fospropofol) [online]. Available from URL: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022244s000_SumR.pdf

More Related