Nurse-administered propofol regularly puts patients at risk

An overwhelming number of patients undergoing nurse-administered propofol sedation for upper and lower gastrointestinal endoscopy actually cross over into general anesthesia, putting them at significant risk for possible complications, including respiratory depression. A pilot study by researchers at Baylor University Medical Center has revealed the findings. Nurse-administered and gastroenterologist-supervised propofol sedation for endoscopy has been advocated in recent gastroenterology publications, and by The American College of Gastroenterology. While propofol’s rapid onset and recovery offer potential advantages in patients undergoing endoscopy, the agent’s therapeutic index is narrow enough that general anesthesia and respiratory depression can be easily induced with its increasing doses.

According to gastroenterologists, the safety of nurse administered propofol sedation in these patients is based upon data in 17,000 cases in which no major morbidity or mortality occurred, other than a few patients who required mask ventilation. These patients are usually monitored with pulse oximetry, and commonly undergo a standard sedation regimen that comprises an initial 30- to 50-mg bolus over five to 10 seconds, followed by subsequent 10- to 20-mg boluses, as required. The total propofol dose can easily exceed 200mg in a single procedure.

In an attempt to determine the depth of sedation attained by such patients, downloaded archived data from 23 ambulatory patients who had undergone colonoscopy using this same propofol technique at the institution, this time at the hands of anesthesiologists equipped with the PSA 4000 depth-of-sedation monitor. A score on the PSA 4000 above 70 represents sedation, commented at the annual meeting of the American Society of Anesthesiologists. Deep sedation is a score between 50 and 70, while scores between 25 and 50 are general anesthesia. And certainly below that is deep general anesthesia.

The investigators found that mean procedure length for the 23 participants was 48.5 minutes. Of this, 26 percent was spent at patient state index (PSI) levels > 70, 44 percent was spent at PSI levels between 50 and 69, 24 percent was spent at PSI levels between 26 and 49 and 6 percent was spent at PSI levels <25. In total, the investigators estimated, 74 percent of patients crossed into general anesthesia. Our conclusion is that these patients are not undergoing nurse-administered propofol sedation, but nurse-administered propofol anesthesia instead. Therefore, we feel they should be trained in anesthesia to do this, and the two weeks of training the nurses typically get is wholly inadequate.

Co-investigator added: His conclusion is maybe a little farther-reaching. He believes that gastroenterologists and nurses are well advised to inform their liability carriers that they are really engaging in general anesthesia. Indeed, both authors were concerned that more individuals in the 17,000-patient database experienced and survived significant unrecognized respiratory depression. The other issue to be mindful of is that anesthesiologists are sometimes made responsible for all anesthetics being given in their hospital. And it’s important for us to know who’s giving what in our hospital, and what our responsibilities are in that regard.

They’re basing the safety of the procedure on 17,000 patients, and think that’s enough. Eventually, they’re going to see some negative outcomes. This is the sort of practice that represents a clear and present danger to the patient population. That fact is that nurses . . . are not trained to administer general anesthesia. They cannot rescue the patients from general anesthesia, and eventually they’ll kill somebody. It just a matter of time. In an editorial, The American Journal of Gastroenterology, the moderate spoke to the fact that he already knew of at least one death associated with nurse-administered propofol. And I’m sure there are going to be a lot more. And this is purely a move by gastroenterologists related to reimbursement. It’s not for improved patient safety; it’s not for improved patient outcomes.

And unfortunately, patients are going to pay a price. The GI community does not appear to have learned its lesson from Versed. When that drug first came out, (it) killed people because they didn’t know how to handle it very well. And while propofol has different characteristics which may make it easier to deal with, expectation is that they’re going to kill people with this drug as well. Many doctors in the emergency rooms also use propofol. But if you look at the package insert, it says you have to be trained in the administration of general anesthesia to safely administer the drug. That warning was not put there lightly and without forethought; it was actually carefully considered. You cannot be an anesthesiologist with a couple of hours of training. It’s a disaster waiting to happen.