Anyone Familiar W/Fospropofol Research ??

  1. :typing Fospropofol is a prodrug of propofol under development for sedation for a variety of procedures, including colonoscopy.[33, 34] Blood levels of propofol after administration of fospropofol reach lower peak levels and are more sustained than after administration of intravenous propofol (Figure 1). This effect creates ease of administration, because for short-duration endoscopic procedures, such as upper endoscopy or colonoscopy, patients may only require a single dose of fospropofol. To improve pain control and to facilitate targeting moderate sedation, fospropofol is co-administered with a narcotic, typically fentanyl. Fospropofol is associated with slight increases in serum phosphorus levels after intravenous administration, but no clinically significant adverse effects from increased phosphorus levels have been observed.[33, 34] Fospropofol administration can be accompanied by the development of paraesthesias during the initial administration, particularly in the groin area.[33] Despite this, a preliminary report of a clinical trial indicates that patient satisfaction is very good.[35]

    A major potential advantage of fospropofol is that the drug manufacturer is seeking approval from the Food and Drug Administration for administration by non-anaesthesiologists. A successful application will avert a situation like that of propofol, for which the package insert suggests that administration should be performed by persons trained in general anaesthesia.

    Following the administration of fospropofol 12.5 mg/kg (the maximum recommended dose) loss of consciousness takes about four minutes, compared to one circulatory time with propofol 2.5 mg/kg (the maximum recommended dose).[1]

    [1] Gan TJ (2006). "Pharmacokinetic and pharmacodynamic characteristics of medications used for moderate sedation". Clin Pharmacokinet 45 (9): 855-69. PMID 16928150

    Your ???
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    About CrohnieToo

    Joined: Jul '05; Posts: 169; Likes: 55


  3. by   Booty Nurse
    Since Fospropofol metabolizes into Propfol, I don't understand why it would be safer than Propofol for a non-anesthetist to administer. There is stll no reversal agent. Why should it be labelled differently than Propofol?

    The ASA is opposed to non-anesthetists giving it: "The ASA submitted formal comments and testified before the Food and Drug Administration’s (FDA) Anesthetic and Life Support Drugs Advisory Committee (ALSDAC) requesting that the labeling for fospropofol disodium injection 35 mg/ml (fospropofol) include a similar warning to that which is included on the label for propofol. Because fospropofol is a pro-drug of propofol and is metabolized in the blood stream into propofol, for patient safety reasons the ASA believes that the drug should be administered only by persons trained in the administration of general anesthesia and not involved in the conduct of the surgical/diagnostic procedure." ASA site Is this due to safety issues, turf battles, or both?

    While I think Propofol is a great drug and part of me would like to be able to give it, I think because of the safety profile, especially the apneic effects and the lack of a reversal agent, an anesthetist should be present.

    Very interesting, Crohnie -- thanks for bringing this to our attention. I had vaguely heard of Fospropofol, but didn't know anything about it.
    Last edit by Booty Nurse on Sep 7, '08