|2005P-0267|| Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons|
|FDA Comment Number :||EC74|
|Submitter :||Dr. Leo Stemp||Date & Time:||09/19/2005 09:09:59|
|Organization :||Western Mass Critical Care, PC|
|Category :||Health Professional|
| I am an anesthesiologist who provides sedation in many gastroenterology endoscopy suites. Fairly heavy sedation is often necessary to complete endoscopic procedures. Although such can be accomplished with midazolam/fentanyl, or other sedative/opiate agents, propofol is certainly THE ideal agent to accomplish this with. However, the vast majority of gastroenterologists, and virtually all the endoscopy nurses (non-anesthesia trained) have no clue about how to manage patients under deep sedation, which by definition causes airway and respiratory compromise. The notion of non-anesthesia trained individuals using propofol is simply laughable, and would predictably lead to tragedies even greater than those that occurred with the original introduction of midazolam.
Attached is the policy I wrote in regards to the use of propofol for sedation.
I would appreciate your taking this into account during your deliberations.