The Great Debate:

Hailed by some as an answer to increased healthcare costs and patient satisfaction, others argue that Nurse-Administered Propofol Sedation (NAPS) is far from harmless. Here we present a variety of opinions from clinicians with first-hand experience.

The Gastroenterologist

John Walker, MD of Medford, Ore. and his partners in Gastroenterology Consultants, P.C., have had excellent results in more than 28,000 cases using propofol sedation as of December 2004. Dr. NAPS, Inc., is a focused training program for physicians and clinical staff on the proper use of propofol sedation.

“This program is not endorsed by any national society,” says Walker of the concise training program. “I don’t think it would be appropriate for me to say that people are qualified to do everything in the future. It would be like me saying, ‘You’ve passed your driving course and you can never have an accident.’ The essence of safety is continuous vigilance.

“We have not had to intubate anyone due to over-sedation in 28,670 cases,” Walker states. “When you start taking care of sick people in the hospital setting, there is no strategy that is perfect. Using an anesthesiology provider all of the time is not practical or acceptable. The other end of the spectrum — not ever using them — is not practical or acceptable either. It becomes a mixed bag in the hospital setting, but our results, quite clearly, are far better than anything published in any language with competing strategies of sedation.”

Many cite the lack of a reversal agent as one of propofol’s main dangers. RNs administering the drug may not be properly trained in airway management, or may not use the skills often enough to be able to respond in the event of an adverse reaction. “We actually think that such a happening is less likely with propofol,” says Walker. “If it were not a safer drug, why would it be the drug of choice for procedural sedation by anesthesiology specialists? I think if you’re giving anybody any kind of sedation, you should be able to take care of the issues that will eventually happen. My personal opinion is that doctors who do procedural sedation ideally ought to have one, two or three weeks working with anesthesiologists in training, regardless of what sedation they’re using. And they ought to have a certain number of ongoing hours every other year above and beyond advanced cardiac life support (ACLS). There are those who think that such amounts of training will not help you out, and that airway events are so rare that there’s no way to keep up your skills. I haven’t ridden a bicycle in a long time, and yet I know how to ride a bicycle.”

Walker is quick to point out that he is in no way cavalier about the subject. “I’m not naive about this,” he says. “If people without adequate training and without adequate respect for the drug were to broadly use this in every location overnight after reading an article, there would be problems.

“My overall attitude is that any syringe medicine needs to be properly identified in terms of what it is, treated with sterile technique, and administered carefully, in that there’s inherent danger in any sedation that we’re giving to people. They can have what I call a linear response — i.e., they get too much; they have too much sedation and perhaps stop breathing, or a non-linear event such as vomiting or laryngic spasm. Page one of my syllabus asks these questions: Is this patient in front of you ready for this procedure? Have you done everything you should? Should you use an anesthesiologist in this case?”

Doctors and nurses should know how to manage an airway, and should practice it, says Walker. “The most important aspect of airway management is being able to mask-ventilate with grace and style. I think the future should be that we look at the science of this, and work for the betterment of our patients, rather than just who’s got the political power. This should not be something that gets dragged down to who’s got dollars to lobby legislators, or lobby to influence boards of nursing. That’s bad medicine.”

The RN

Val Charley, RN, has served as the endoscopy department manager of the Surgery Center of Southern Oregon for almost four years. Eight nurses on staff use Diprivan® (Astra-Zeneca’s brand of propofol). “That’s all we use here unless the patient is allergic to one of the components of Diprivan,” she says. “It has really increased patient satisfaction — they have a totally painless experience, and wake up feeling like they’ve had the best nap of their life; they’re happy; they’re awake. Our goal is to prevent colon cancer, and right now there are a lot of people out there over the age of 50 who haven’t had their colonoscopy done because they’re afraid of pain. If we can spread the word that colonoscopy can be a painless exam, we’re going to get a lot more people who are willing to have it done.”

Charley notes that nurse and physician satisfaction are also increased because patients are not in pain. “It’s easier on the patient and it’s easier on us,” she says. “We get our exams done smoothly, more quickly, and propofol works really well on those patients who are difficult to sedate with benzodiazepine and narcotics — sometimes you just can’t sedate certain individuals with those kinds of drugs, and we end up having to call anesthesia anyway. This happened when I was working in the hospital and we weren’t using propofol — we would have to call anesthesia in to give them propofol, because it works nearly every time.

“The procedure start-up time is faster, we can usually start the procedure about one minute after we’ve begun sedation,” continues Charley. “Recovery time is quicker — usually 15 to 18 minutes. The patient has far better recall — we don’t have to keep repeating ourselves like you do when they’ve had Versed. Procedure times are shorter, so we can do more procedures per day.”

An additional benefit is that propofol is quickly out of the patient’s system, says Charley. “It has a very short half-life. About three to five minutes after we’ve stopped sedation, they’re beginning to wake up. There is no nausea, as it has an anti-emetic property to it.”

Are RNs adequately trained to handle an airway emergency? They should be, if they’re administering any kind of sedation, says Charley. “First of all, it’s not likely that something is going to go wrong if they’re trained properly and they’re diligent in what they’re doing,” she says. “In the doses that we give, it would be very unlikely that something would go terribly wrong. The same thing can happen with Versed and Fentanyl or any of the benzodiazepines/ narcotic combinations used for sedation. It’s the same thing — if something happens, we’re still going to be in trouble. Whatever you’re using, there is a risk. I don’t mean to sound like nothing could ever happen with propofol. I have a profound respect for this drug. Sooner or later with any type of sedation or anesthesia, something is going to happen. The longer you do something, the greater the chances are that something will go wrong. I’m just saying that with good airway management skills, good support and backup, and extensive training and competencies in place, you lessen your risk.”

Charley believes that those who are opposed to NAPS are those who are unfamiliar with the drug. “The ones who are for it are the ones who have actually used it, and know what a wonderful drug it is,” she says. “I’ve been backed up by a lot of anesthesiologists who are in agreement with this: Propofol is a very safe drug given by RNs. If the RN’s No. 1 priority is patient safety, if the RN has been trained and is competent in airway management, and is diligent in adhering to the protocols that have been put in place, I feel it’s a lot safer. No.1, you can titrate your dose; you have more control. No. 2, the half-life is so short.”

The Anesthesiologist

Jospeh Stirt, MD is a board-certified anesthesiologist, well-versed in the use of propofol for sedation in the endoscopy setting.

“By the time propofol was released, after many, many years of study, I knew that its side effect profile was that it hurts like hell when it goes in — it burns,” says Stirt. “To me, this is why it’s a brain-dead drug and I don’t understand it. Everyone’s known that from the beginning. Everyone adds lidocaine to the propofol syringe.

“You learn that real soon, after the first time you give it and the patient screams that his arm is burning. When you’re selling me an expensive drug that you have to dilute with something else in order to prevent it from hurting someone, and telling me that this is better than what you had before, I don’t buy it.”

Although Stirt is categorically propropofol for use in endoscopy, “It’s deceptively dangerous,” he says. “People use it over and over and don’t get into trouble, and they think they’ll never get in trouble. Therefore, the guard goes down, trouble happens and there’s no one in the endoscopy suite who knows how to manage an airway. And the usual cascade of disaster occurs.

“I am totally pro-Propofol for endoscopy — don’t get me wrong,” Stirt continues. “I am only saying that those who use it still have to have airway management expertise. That’s where I have trouble, but I had that same objection with Pentathol or Valium or narcotics in the endoscopy suite.”

The RN must be adequately trained, stresses Stirt. “Some RNs are fine. Some RNs can manage an airway, and I have no problem with them. But some have no clue about it — all they do is take care of the patient in the recovery room, and then the surgeon or the endoscopist says, ‘Push the propofol.’ The endoscopist has no clue; that patient is heading for death in the endoscopy suite. I review cases like this every year, in which a patient dies or becomes a vegetable from drugs administered in the endoscopy suite. I know whereof I speak. Some people have opinions. I’ve got a basement full of files that tell the story. It’s frightening.”

Stirt also cautions that even given the low dosage used in endoscopy, trouble still exists. “Occasionally, a reduced dose will unexpectedly cause a major respiratory depression. You can give the drug safely to most people; nothing will happen.

But there’s someone out there — one in 100 patients, one in 28,000 — whatever you want to use for your denominator — who is all of a sudden going to stop breathing, and now you’ve got a problem. Especially in a dark room, where everybody’s buzzing around doing other things, and there’s not a person dedicated to simply watching the patient in terms of vital signs, airway, etc. Extremely infrequently, but it happens.”

Stirt does not believe that the answer lies in endoscopic anesthesia being administered by an anesthesiologist. “It’s impossible,” he says. “There aren’t enough to go around, not even close, not even certified registered nurse anesthetist (CRNA)s. There’s no question that other people have to do it, that you can’t maintain American medicine and do the cases if we’re going to demand a board-certified CRNA or anesthesiologist to push drugs in the endoscopy suite.

“First of all, the insurance companies are not going to pay for it,” he continues. “Secondly, there aren’t enough to go around. It’s got to be done by people without primary airway expertise. My only advice would be that someone should try to gain some degree of familiarity with how to maintain an airway. People say, ‘I take ACLS.’ It doesn’t matter what you take, it’s what can you do? Managing airway is very difficult.”

The skills used in maintaining an airway have to be used to remain effective, says Stirt. “At one extreme there’s, is it a skill— is it like riding a bicycle? Is it like swimming? You can go 20 years and most people who know how to swim, if you get back into the water, you won’t drown. You won’t swim like you did 20 years ago, but you won’t drown. That’s what we’re trying to get the equivalent of here in the endoscopy suite in an emergency. We’re not asking for a perfect airway, we’re asking for enough oxygen and CO2 to be moved back and forth that the patient can be kept alive and brain intact until expert airway assistance arrives.”

Propofol leaves the patient’s system faster than other sedatives, but that’s deceptive too, says Stirt, when other narcotics are added to manage the burning sensation the patient feels when propofol first enters their system. “If you’re going to add other drugs to the cocktail, you create an entirely new situation for yourself. Propofol will leave rapidly compared to other drugs, which will hang around. If you add the other drugs, now you’re in a situation where you’ve got a much longer wait until you get a return of function in general.

“Propofol by itself is probably the safest way to go in the endoscopy suite,” says Stirt. “If you asked which drug or drugs should I use to give the patients sedation for endoscopy, I would say propofol by itself. No question. Because it is relatively rapidly acting and offsetting, and once it starts to go away, the patient does wake up.”

The Attorney

Deborah A. Krohn, RN, BA, JD, Siegel & Krohn, PC is both a part-time endoscopy nurse and part-time attorney, knowledgeable on the topic of NAPS from both a clinical and a legal concern.

“It’s such a complex issue,” she says. “First and foremost, I’m a patient advocate. I have big, big patient safety concerns, because I believe patients should have their airways managed expertly when and if they need it. My second concern is always nurses. I’m concerned for nurses that have either been asked to practice outside their scope of practice, who feel pressured, even feel the economic pressure of, ‘If we don’t acquiesce to training for propofol administration, we’re going to have anesthesia in the rooms, there will just be techs, and there won’t be any need for nurses.’ There’s an economic influence there that nurses fear — loss of job.”

Krohn did some independent research on the subject, emailing literally every nursing board in the country. In response to the standard question, “Does your nurse practice act allow for the practice of nurse- (meaning RN, not CRNA) administered propofol for the purposes of procedural sedation?” The results were enlightening:

22 states: Permitted/no prohibition
21 states: Not permitted
5 states: No position/unclear
2 states — Michigan and Nebraska —did not respond.

Krohn says it is important to define the terms. “We’re not talking about sedation of intubated patients in the ICU, we’re talking about 50-year-olds walking in off the street for a screening colonoscopy and expecting to go shopping on the way home.”

The bottom line, Krohn says, is this is very much an evolving situation, in as much as it is on the dockets of nursing boards on a monthly basis. “It’s getting attention. It’s a very dynamic, evolving issue. And you’d better pay attention because chances are, your hospital doesn’t allow it — that’s the trend right now.”

As a clinician, Krohn is quick to point out propofol’s good points. “There are clinical attributes that contribute to its curb appeal,” she says. “It is ultra-fastacting — within 45 seconds of it hitting your system, you are sedated. It’s very effective — people have no complaints about being under- or over-sedated, and recovery is shockingly fast.

“The economic appeal is it is considered to be such a safe drug,” Krohn continues. “The safeness lies in the fact that it’s metabolized so quickly. They believe that even if you get into trouble, you can get bagged, your airway could be supported. However, in two minutes you’re going to be awake, so what’s the harm? But when I talk to my friends who are anesthesiologists, they tell me the bottom line is, it fails the big test: would you do this to your baby? Would you let a nurse give your baby or your mother this drug, knowing that there is no reversal agent and the nurse is not experienced in bagging a patient? The opportunity for an endoscopy nurse to bag a patient is hardly ever. Even if you get trained in it, if you don’t use the skill, you lose it. It fails the baby test; it fails the mother test. Then you tie in a nurse’s ethical responsibility — to be a patient advocate.”

This raises the issue of informed consent, says Krohn. “I don’t have the answer. But I think if there is a misadventure with propofol, it could be a valid question posed by a plaintive attorney: Did the doctor explain to the patient before the procedure that he was going to have administered a drug for which there is no reversal, and the rescue of the patient would be in the hands of a nurse who is not an expert in airway management? And that the very administration of that drug was something about which there is no consensus? Meaning, it’s not the standard of care.

“Does your professional liability insurance carrier know what you are doing, and if so, are they on board with it?” Krohn continues. “Insurance companies presume that you are practicing within the standard of care, and that if you’re going outside the standard of care, you ‘re going to have fabulous reasons for doing it, well-documented and supported by the literature, etc.”

Another area that begs attention from a legal point of view, Krohn says, is the wording on propofol’s package insert. AstraZeneca provides the following inpackage warning: “For general anesthesia or monitored anesthesia care (MAC) sedation, DIPRIVAN Injectable Emulsion should be administered only by persons trained in the administration of general anesthesia and not involved in the conduct of the surgical/diagnostic procedure. Patients should be continuously monitored, and facilities for maintenance of a patent airway, artificial ventilation, and oxygen enrichment and circulatory resuscitation must be immediately available.”

“If I was a plaintiff attorney suing a hospital doctor and nurse for a propofol misadventure, the package insert does not carry the day in terms of positive proof of violating the standard of care, which is what you have to prove in malpractice,” says Krohn. “But it’s a very strong weapon in the arsenal that a plaintive attorney will bring to the trial. The plaintive attorney will say, ‘Did you not read this? Do you think this is information that has value, and that’s why it’s on the package insert — because the manufacturer wants to communicate it to all users, or do you think that you’re in a position to dismiss information? Why do you feel free to disregard it?’ You really could have a field day with that — here it is in black and white from the person who makes the drug.”