2005P-0267

Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons

FDA Comment Number :

EC139

Submitter :

Dr. Samuel Budnyk

Date & Time:

11/01/2005 04:11:59

Organization :

None

Category :

Health Professional

Issue Areas/Comments

GENERAL

I am a practicing anesthesiologist.I have been delivering anesthesia since 1991. I have extensive experience administering propofol for intravenous sedation including sedation for colonoscopies and cardioversions. Both of these procedures are very stimulating/uncomfortable to the patient. Propofol is not a very effective medication for pain control. It is a very powerful hypnotic/sedative. Propofol is not used as a mild sedative. It is used to provide a very deep level of sedation/general anesthetia. Its advantage is that it allows a deep anesthetic to be delivered quickly and effectively which typically resolves in 5 to 15 minutes. Patients are typically brought in and out of levels of deep sedation and general anesthesia during the procedure as propofol is CLOSESLY titrated. The patients receive one-on-one care from the anesthesiologist/anesthetist as the patient's level of sedation, airway patentcy, respiratory rate, response to the procedure and vital signs are closely monitored. It is very common for the anesthesia provider to have their hand on the patient's chest to measure respiratory rate and chest wall excursion to help determine the level of sedation or to have one's hand in front of the patient's mouth feeling for good airflow during exhalation. The point being very close monitoring is necessary and currently is being provided.This will change if you allow those not skilled in providing general anesthetics administer propofol. Propofol sedation can and will be very dangerous for patients if they are not monitored closely, without distractions, from experienced anesthesia providers. There is a significant risk of cessation of breathing, loss of airway patentcy, loss of airway protective reflexes against aspiration, hypotension, bradycardia and oversedation with the use of propofol.

It is very common that through the course of the procedure that patients may stop breathing, their airway close off, or their blood oxygen saturations decease below 90%. The anesthesia care provider due to focused diligience and a immediate response time is able to minimize the frequency and the extent of these episodes. I would have to believe the the frequency and extent of these episodes would increase if person skilled in administering a general anesthetic was not present. I do not think more prolonged and frequent episodes of hypoxia would be good for the geriatric population, or anyone for that matter.The line from giving the amount of sedation needed for the procedure and too much is very fine, and the practioner administering the sedation needs to be vigilant and very skilled in airway management and resusitation. During sedation with propofol the provider administering the drug needs to be focused on the patient as many times during levels of severe stimulation from the procedure the patient sedation level may drift in and out of a general anesthetic as more propofol is given. I do not think this fact is appreciated when you are not intimately involved in giving the anesthetic versus just directing a nurse to give more, and that is what will happen. When the gastroenterologists (or other providers) get into trouble with their sedation, ie loss of airway, or arrest, they are not skilled in handling these situations and a outside provider is called in. Typically 'Anesthesia Stat to the GI Suite' is heard over the loud speaker. If you make this change it would be for the convenience of the proceduralist to the determent of the patient. The FDA would make something that currently is very safe due to the expertise and diligence of the anesthesia provider into a very risky procedure because you will have someone not skilled in monitoring, administering or managing an anesthetic be administering a general anesthetic. Remember propofol is not a very useful drug for mild sedation. This drug is used for deep sedation/general anesthesia.