2005P-0267 Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
FDA Comment Number : EC128
Submitter : Dr. Alan Angel Date & Time: 11/01/2005 04:11:03
Organization : Dr. Alan Angel
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
I have used propofol sedation for several thousand endoscopic procedures over the last several years. Propofol is not an analgesic agent nor does it produce amnesia in a conscious patient. It only provides patient comfort during an endoscopic procedure when the drug is titrated to produce a state of deep sedation or light general anesthesia in the patient. Propofol is ineffective for endoscopic patients when titrated to a level that is less than deep sedation.

In evaluating the request for non-Anesthesiologist/CRNAs to administer propofol, the above reality must be kept in mind. The non- anesthesia providers are asking to use propofol to provide conscious or moderate sedation. Since propofol is effective for endscopic procedures only when titrated to a level of deep sedation or light general anesthesia, the FDA is being misled as to how propofol will be actually utilized.

To allow non-Anesthesiologists/CRNAs to routinely sedate patients with propofol to levels of deep sedation or light general anesthesia is an invitation to major problems. As an Anesthesiologist with over 20 years of experience, I find that providing propofol sedation to endoscopy patients every bit as challenging as providing general anesthesia to surgical patients. In fact, propofol sedation for endsocopy patients presents challenges not seen in the operating room.

In the operating room, we can give a relatively standard dose of propofol and then take over the patient's airway. In the endscopy suite, the propofol has to be titrated much more carefully. Too little, and the patient will move and be uncomfortable. Too much, and the patient may stop breathing or obstruct their airway. The amount of propofol that I use for a typical procedure can vary by more then 10-fold between patients. This takes a lot of experience to get right.

If a family member of mine was to have propofol sedation for an endoscopic procedure, I can say for certaintly that I would want to have a CRNA or Anesthesiologist providing the sedation. I would not want a nurse that took a two day course in sedation providing the care. The extra cost involved is worth the comfort and safety provided.

By the same token, if a family member of mine required an endoscopy, I would seek out a board certified gastroenterologist to do the procedure. I would not seek out a nurse who took a two day training course in the performance of endscopies.