2005P-0267 Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
FDA Comment Number : EC135
Submitter : Mr. Nick Hill Date & Time: 11/01/2005 04:11:21
Organization : Mr. Nick Hill
Category : Health Professional
Issue Areas/Comments
I am a CRNA and have done literally thousands of g.i. cases over my 20 years of experience. Prior to the use of propofol sedation for g.i. procedures were
done by docs ordering RNs to administer large doses of narcotics and benzodiazpines to patients who then required the use of narcan and other reversal agents. with the adv ent of propofol anesthesia providers were invited into the g.i. labs to assist with sedation. That was a good thing. But putting propofol in the hands of g.i.docs and rns in the g.i. labs without
an anesthesia provider is not a safe idea. We all get tunnel vision when it comes to our own areas of expertise and when the doc is looking at the scope monitor and the nurse is assisting them and the lights are out becomes a potential death trap. Even with the addition of a 2nd nurse to monitor the patient. Only persons trained in the use of general anesthesia are qualified to give general anesthetics. Dosing is relative to too many subjective criteria and our ablities that are honed for many years in O.R. Is the only thing that insures saftey in the use of propofol in the G.I. labs