Today's SurgiCenter - Clinical Update

Anesthesia Operating in the Danger Zone

By John Roark

Projections for the year 2004 are that 80 percent of all surgery will be done on an outpatient basis, with 20 percent of all surgery done in a physician’s office. Yet when it comes to anesthesia, fewer than 10 states enforce any regulations or rules related to office-based surgery. Are those who are administering sedation adequately trained to respond in case of emergency?

“In the vast majority of states, not only do they not mandate accreditation, they also do not in any way, shape or form have rules, regulations or anything that applies to the office-based setting,” says Jeffrey Apfelbaum, MD, professor and chairman of the Department of Anesthesia and Critical Care at the University of Chicago Hospital. “It’s very scary, and that’s an area of deep concern to the profession. All of a sudden we’ve gone from what’s done in an office being miniscule to being a fifth of all surgical procedures. And very few states right now have any regulations regarding safety in the office setting. In the vast majority of states it is completely unregulated. That’s of enormous concern.”

Several accrediting bodies — the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), the American Association of Ambulatory Surgery Centers (AAASC) and the American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF) — have accreditation programs for office-based surgery.

“The American Society of Anesthesiologists has standards in place for office-based surgery, statements and policies in place that have been developed over the last several years, and it’s all public information — they’re available on the website, and there’s a number to call to request printed materials,” says Apfelbaum.

The Guidelines

In 1999, the ASA approved a Definition of General Anesthesia and Levels of Sedation/Analgesia, and defined four levels of sedation analgesia:

• Minimal sedation (anxiolysis) is a druginduced state during which patients respond normally to verbal commands. Although cognitive function and coordination may be impaired, ventilatory and cardiovascular functions are unaffected.
• Moderate sedation/analgesia (“conscious sedation”) is a drug-induced depression of consciousness during which patients respond purposefully* to verbal commands, either alone or accompanied by light tactile stimulation. No interventions are required to maintain a patent airway, and spontaneous ventilation is adequate. Cardiovascular function is usually maintained. (* Monitored anesthesia care does not describe the continuum of depth of sedation, rather it describes “a specific anesthesia service in which an anesthesiologist has been requested to participate in the care of a patient undergoing a diagnostic or therapeutic procedure.”)
• Deep sedation/analgesia is a drug-induced depression of consciousness during which patients cannot be easily aroused but respond purposefully** following repeated or painful stimulation. The ability to independently maintain ventilatory function may be impaired. Patients may require assistance in maintaining a patent airway, and spontaneous ventilation may be inadequate. Cardiovascular function is usually maintained. (**Reflex withdrawal from a painful stimulus is NOT considered a purposeful response.)
• General anesthesia is a drug-induced loss of consciousness during which patients are not arousable, even by painful stimulation. The ability to independently maintain ventilatory function is often impaired. Patients often require assistance in maintaining a patent airway, and positive pressure ventilation may be required because of depressed spontaneous ventilation or drug-induced depression of neuromuscular function. Cardiovascular function may be impaired.
• Because sedation is a continuum, it is not always possible to predict how an individual patient will respond. Hence, practitioners intending to produce a given level of sedation should be able to rescue patients whose level of sedation becomes deeper than initially intended. Individuals administering moderate sedation/analgesia (“conscious sedation”) should be able to rescue patients who enter a state of deep sedation/analgesia, while those administering deep sedation/analgesia should be able to rescue patients who enter a state of general anesthesia.1
• “The recommendations are that basically any provider of sedation can provide mild or moderate sedation, but that it really takes someone specially-trained in anesthesia to provide deep sedation or general anesthesia,” says Apfelbaum. “The logic behind that is, it is a continuum, and it’s easy to slide one level deeper than you intend to be. You need to have the skills necessary to rescue someone from one level deeper than you intend to be. Typically, if you look at these new definitions, you need those specialty skills to rescue someone from deep sedation or certainly from general anesthesia. Aspiration is one of the dangers. Cardiac arrest is not far down the road from that. It is a continuum, and it’s very easy to slide up or down the scale very quickly.”

The Danger Zone

“The advantage of conscious sedation is that in its simplest sense, it can be done anywhere,” says Joseph A. Stirt, MD. “Ninty-nine point nine percent of general anesthetics happen in operating rooms. Conscious sedation can happen in an operating room, in a dentist’s chair, a doctor’s office — anywhere that medical care of any sort is given. So therefore, the people who can give conscious sedation multiply as compared to those who can give a general anesthetic from the limited group of anesthesiologists and nurse anesthetists. All of a sudden, anybody who can hold a syringe and push the plunger down can give conscious sedation, which means in some cases ancillary office personnel, office assistants, people who don’t have formal training in the administration of drugs. That opens up the practice of conscious sedation to basically anyone. You could give a ten year old the syringe, and say, ‘Whenever the patient complains, just give a little more of that drug.’ But the problem then that you run into is that conscious sedation can become a general anesthetic. And when it becomes a general anesthetic, it becomes potentially much more lethal.”

“What happens, unfortunately a little bit too often, and what keeps my consulting business busy, is when the person administering the conscious sedation really wasn’t capable of understanding that he or she had crossed this sort of line,” continues Stirt. “It’s not a line, like stepping off a curb and you know you’re in the street. What you have here is kind of like a wheelchair ramp. The top is conscious sedation, and the bottom is general anesthetic. Somewhere along that ramp you get to a certain point where the patient is no longer conscious. To an untrained individual, that may not be clear.”

“The precise danger of the shift from consciousness to unconsciousness, in practical terms, is the fact that unconsciousness is correlated with the lack of ability to control the airway,” says Stirt. “The absence of the patient’s ability to respond appropriately, and the ability to close the vocal cords should there be reflux and regurgitation from the stomach — those two things happen pretty much in parallel. The danger is not that the patient becomes unconscious per se, because an unconscious person will breathe, the heart will beat, blood pressure is fine. The danger is that should that patient have regurgitation or reflux of stomach contents, because of the administration of drugs that made the airway and the brain stem basically lose consciousness — those protective reflexes that would cause you or I immediately to gag and choke and cough, aren’t there, and that patient will aspirate.”

“When you sedate a patient with narcotics, you get respiratory depression,” says Stirt. “These drugs depress the brain stem and respiratory centers. They decrease respiratory rate and volume. So, associated with the sedation is a decrease in gas exchange. Often the person administering sedation unfortunately isn’t doing just that, but is doing a lot of other things. Overhead is high, and labor costs a lot of money. That person may be getting instruments, writing vital signs down, going to the head of the table and push some drugs, then running back to get another instrument that they need. Respiration doesn’t just stop, it slows down gradually. The question is, How slow is too slow? For instance, I can be comfortable with someone breathing eight times a minute if I’m satisfied that they’re oxygenating well and that there’s enough gas exchange and blood pressure is okay. But some other patients whose respiration drops to eight a minute may be shallow, they may have decreased cardiac output, they may be retaining carbon dioxide, they may be heading towards some cardiac arrhythmias.”

“When I start my anesthetics, I give small doses,” continues Stirt. “Enough times that it is remarkable — and it makes me pay very close attention, and never turn my back on a patient when I’m doing all this stuff — that first cc will knock the patient out. I’ll turn to them and say, ‘Are you comfortable?’ and they’re out. That’s no longer conscious sedation — that’s a general anesthetic right there.”

“The problem is that the casual administer, the person who has not really been trained in a formal sense, doesn’t have enough exposure to disaster,” says Stirt. “Every resident nurse anesthetist has dealt with disaster in the OR, whether it’s their fault or someone’s else’s or no one’s fault. They still are experienced enough that they at least have a passing sense of what to do when the patient starts regurgitating, such that it’s not immediately a death or brain death outcome. Patients do aspirate, they do regurgitate, and they do fine if the disaster is handled right. It’s the lack of experience in extremis that leads to real disaster.”

“My feeling is that most of these procedures have to be done, and they’re certainly not all going to be done in an OR, because nobody’s going to pay for it,” maintains Stirt. “So they’ll have to be done in a doctor’s office by whoever’s there. But I have to say that there is a small but real risk. Most of the time you can screw up and nothing happens. Most of the time people don’t screw up, so you’re talking about the times you do screw up and something bad happens. It’s not often, but it’s often enough if you’re that person.”

“Who should be administering moderate sedation or whatever type of sedation is being given?” asks Stirt. “Should it be an RN, LPN, a physician’s assistant, the office business manager, secretary? Under the direction of the physician, endoscopist, surgeon or practitioner?

Independently, or the two of them working together? The drugs are so secondary to the person giving them that it almost pales in comparison. It really boils down to who is prepared to intubate the patient should they develop a respiratory obstruction. Basically the only people who can be relied on to intubate in a hurry with certainty are people who are trained in anesthesiology.”

The Fast Track

Changes in surgical technology and advancements in surgery combined with the development of newer, faster-acting anesthetics has enabled providers to offer care to patients and send them home safely after surgery in ways that are very different from the procedures of yesterday. “As little as 10 years ago, if you had your gallbladder removed surgically, it was common for you to have a nine to ten day hospitalization,” says Apfelbaum. “Now, between the advancements in surgery and the advancements in anesthesia, with over half of all cholecystectomies performed, the patients are able to go home the same day.”

“Fast tracking” is popular with anesthesiologists because of advances in rapid-onset, fast-emergence general anesthetics (e.g., propofol, desflurane, sevoflurane), bispectral index monitoring/the increased use of prophylactic drugs for postoperative nausea and vomiting, and preemptive pain control. With the use of these anesthesia techniques, patients can be completely awake and oriented with stable vital signs in the OR shortly after a brief surgical procedure with general anesthesia. When done correctly, patients spend less time under anesthesia and have fewer complications, with less postoperative pain, nausea, and vomiting.

Financial considerations have also contributed to the popularity of fast tracking. Fast tracking is seen as a way to improve efficiency in patient care and to decrease the amount of time that patients spend in phase I PACU. Costs can be reduced even more if patients can completely skip phase I and proceed directly to phase II PACU.2

What’s Ahead

“Clearly, leadership from the ASA has been at the forefront of developing new techniques and pushing the forefront of science, if you will, to understand how and why these things enable us to change practice patterns,” says Apfelbaum. “Typically it takes generations to change the way people practice clinically. The ASA and the scientists involved in that organization have really been at the forefront of understanding the mechanisms of sedation, the mechanisms of interoperative anesthesia, as well as post-operative analgesia — post-operative relief of pain — and there are new techniques that are literally being developed as we speak with regard to all three of those. It’s hard to predict where we’re going to go. I think it’s safe to predict that there are going to be significant changes.”

Stirt, on the other hand, believes things will stay primarily the same in the foreseeable future. “The drug companies will tell you that they’ve got all this great new stuff coming out,” he says “I started my training in 1977. The drugs I used then for conscious sedation were Fentanyl and Valium. Now it’s 2003, and when I have a patient and use conscious sedation, the drugs I use now are Fentanyl and Lorazepam, which is a shorter-acting Valium. That’s 26 years and I’m using the same drugs. I read the journals every month — I don’t see any new awesome great drugs or techniques in the pipeline. Basically I think things are going to stay the way they are for the foreseeable future 10, 20 years.”

References:

1. http://www.asahq.org/publicationsAndServices/standards/20.htm. Referenced August 11, 2003.

2. Conner R. AORN Journal. June 1999.