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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

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Fospropofol for sedation

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  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

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