Patient controlled sedation

[toughlife]

CLINICAL ANESTHESIOLOGY



ISSUE: JANUARY 2007 | VOLUME: 33 printer friendly | email this article | more clinical anesthesiology

Patient-Controlled Sedation Viable for Colonoscopy

Rebecca Voelker




As controversy swirls around who should administer anesthesia during colonoscopy and how much, if anything, insurers will pay for it, a Philadelphia anesthesiologist has suggested ways to improve efficiency in the endoscopy suite while keeping anesthesiologists on board.

The solution: patient-controlled sedation with propofol and remifentanil, said Jeff E. Mandel, MD, MS, of the Hospital of the University of Pennsylvania. Dr. Mandel presented his findings at the 2006 annual meeting of the American Society of Anesthesiologists (ASA). The results, he said, hold important implications for the traditional model of staffing sedation during colonoscopy.

The question of who should be permitted to administer propofol (Diprivan, AstraZeneca) during colonoscopy is highly charged—and heavily freighted with dollar signs.

Gastroenterologists have argued that they are no less equipped than anesthesiologists to provide propofol to low- and average-risk patients, and that the presence of an anesthesiologist or anesthetist is not necessary when the drug is being given. Meanwhile, anesthesiologists have typically insisted that the risks to patients are greater in their absence.

Insurance companies such as WellPoint, Inc., have leveraged the dispute to restrict reimbursement for propofol colonoscopy, refusing to cover the sedative during routine endoscopic procedures. And in 2006, Aetna announced that it planned to suspend coverage of monitored anesthesia care (MAC) services during upper and lower gastrointestinal (GI) endoscopy procedures on most healthy patients.

The company subsequently put the new policy on hold. However, several sources told Anesthesiology News that Aetna was planning to restrict its MAC coverage for GI endoscopy starting in early 2007. The company would not confirm such a policy change.

Susan Millerick, an Aetna spokeswoman, said that the insurer had decided to act on MAC for GI endoscopy after a review of anesthesia delivery during endoscopy found “a wide variation” nationwide that can lead to “potential overuse, underuse or misuse of appropriate anesthesia services for GI procedures.” Ms. Millerick added that Aetna has “received input and feedback from professional societies and physicians on the issue of coding, including the ASA.”

That fact has irked some anesthesiologists, who feel that the ASA, by providing Aetna with diagnostic codes, violated its own policy of refusing to allow insurers to define “medically necessary” procedures. ASA, for its part, defended its actions, saying that failure to engage the company would have led to a far worse policy for anesthesiologists (see story below).

Technology-Based Compromise?

The latest research (A570) may not obviate the insurance issue, but it does suggest a possible middle ground between battling medical specialties.

Dr. Mandel’s study examined the use of patient-controlled sedation (PCS) in 25 patients who received propofol and remifentanil (Ultiva, GlaxoSmithKline) (PR) and 24 who received midazolam and fentanyl (MF).

Patients received either 10 mg/mL of propofol and remifentanil at 10 mcg/mL (2.5-mL load, 0.75-mL demand, no lockout) or a combination of 0.5 mg/mL of midazolam and fentanyl at 12.5 mcg/mL (4-mL load, 1-mL demand, one-minute lockout). Oxygen saturation below 85% for 60 seconds was the main safety end point. The randomized, double-blind study compared time to achieve sedation, procedure time and time to ambulation between the two groups.

Patients in the PR group were sedated more quickly (3.4±1.3 minutes vs. 7.6±3.6 with MF) and had shorter time to ambulation (9.2±4.0 minutes vs. 36.4±5.3 with MF). Two patients in the PR group required intervention—two breaths from an oxygen mask with a Mapleson circuit; neither needed intubation. Patient, nurse and endoscopist satisfaction was high.

PCS isn’t currently considered standard care in colonoscopy, but Dr. Mandel said he believes it improves patients’ safety by keeping them “in the loop” with their medication. Several studies have examined PCS during colonoscopy, and for most patients it appears to be as safe and effective as standard sedation.

Dr. Mandel said his findings are important for several reasons. Propofol-remifentanil used with PCS shaved about 3.5 minutes from each case, compared with MF. “That might seem like nothing, but if you’re doing 10 to 15 cases per day, you might fit in one or two additional cases,” he noted.

Quick recovery time in the PR group suggests the need for fewer staff in the postanesthesia care unit, he added. The resulting increased revenue could support the continued presence of anesthesiologists in the endoscopy suite, generating safety benefits for patients and bolstering the financial health of anesthesiology practices.

In essence, Dr. Mandel is trying to revamp the traditional surgicenter model of anesthesia during endoscopy. By pairing PCS with fast-acting sedation and quick recovery times, surgicenters might have one anesthesiologist for every three to five procedure rooms.

“With technology for monitoring, we could watch the patients from outside the room,” he said. “[Anesthesiologists] determine what drug is given, what the pre-op risks are, what goes into the pump, and then are available in an outside area for rescue,” he said. Automated systems can take care of record-keeping and control functions, he added.

Dr. Mandel plans to determine more exact cost savings with the model he suggests. Without a change in current trends, he added, anesthesiologists “will be out of routine sedation in the endoscopy suite within two years.”

Not everyone agrees. Stacie Deiner, MD, an anesthesiologist in Port Jefferson, N.Y., said she wouldn’t be comfortable with having remifentanil in a propofol infusion in a room where she wasn’t present. Dr. Deiner said remifentanil may cause apnea or blunt airway reflexes, especially when used with other drugs—most notably propofol. “Unsupervised PCS with these extremely potent drugs is against our core values,” she said. Her practice, Long Island Anesthesia Physicians, performs 600 to 700 colonoscopies per month at John T. Mather Memorial Hospital in Port Jefferson and at outpatient surgicenters. “We use anesthesiologist-administered propofol,” she said. Dr. Deiner noted that PCS could increase time to sedation and procedure duration because of the small doses patients receive. Also, patients have to regain consciousness to redose themselves and therefore risk injury if they move during the procedure.

Dr. Deiner also disagreed that anesthesiologists will be replaced in endoscopy. Even though gastroenterologists sedated their own patients until recently, she said, many are not comfortable using newer, fast-acting agents such as propofol. Also, their staff are trained in conscious sedation but can’t safely administer intravenous general anesthesia. “The staff loves having anesthesiologists there because they know we are trained to rescue patients who have adverse reactions or have higher dose requirements and need different regimens.”

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[Gasboy07]

Sorry are they nuts? Did I hear someone even thinking about giving remi and propofol without someone in the room who is giving their undivided attention to their patient's airway and safety?

The bigger problem might be the fact that the patient needs to be reasonably awake to control the PCS, and not having had a colonoscopy myself, my patients seem to want to not be that awake. My usual practice is to use propofol only, and get them deep enough so they don't move (but aren't apnoeic), then give a bit more when they show signs of stirring (or when I think it's about right). Different story for gastroscopes...

And let's see - how much do you need to save to pay for one perforated bowel?

 

[JeffEMandel]

Sorry are they nuts? Did I hear someone even thinking about giving remi and propofol without someone in the room who is giving their undivided attention to their patient's airway and safety?

This is a correct interpretation of what I said in my interview with Anesthesiology News (as well as Gastroendoscopy News). The intent of this project is to determine a safe model for sedation of patients undergoing colonoscopy without single provider coverage. Unfortunately, Anesthesiology News is not quite the peer-reviewed journal from which one would want to get the total picture. The full manuscript is under review, and will hopefully be available "real soon", but I can address some of your concerns.
First, the current study was not a safety study, it was a facility utilization study. What that mens is that the study was not designed to determine whether propofol-remifentanil could be used without an anesthesiologist in the room, only to compare the two mixtures for speed of sedation and recovery under identical conditions. I was present in the room for all 49 procedures, and intervened twice for the propofol-remifentanil. The endpoint for intervention was 60 seconds of saturation < 85%. We can discuss the merits of that endpoint, but try googling "Severinghaus hypoxia" and you'll get a feel for how well people tolerate short episodes of hypoxia. Since I don't need to be in the room to detect the onset of desaturation, the question is how far away can I safely be and get there to intervene, which is in many ways analogous to the question of how far away from a CA-1 resident can I be.
Second, the gastroenterologists already have statistics demonstrating over 100,000 colonoscopies under NAPS (nurse-administered propofol sedation). I'm not advocating it, I'm just telling you it has been done. The person most associated with this is Doug Rex, who assures me that he only does NAPS in an environment where he can hit a button on a wall to summon an anesthesiologist. This is significantly more risky an approach than that which I'm advocating.
Third, how many patients get labor analgesia with dedicated anesthesia coverage? I guarantee you that bupivacaine is more toxic than propofol-remifentanil; I was working in the OR t the Brigham the day Rick van Pelt did the popliteal fossa block that resulted in a 30 minute pump run. We have worked out safe ways to have patients get dangerous drugs safely with multitasking anesthesiologists.

The bigger problem might be the fact that the patient needs to be reasonably awake to control the PCS, and not having had a colonoscopy myself, my patients seem to want to not be that awake.

The satisfaction numbers in my study would indicate otherwise; patient controlled sedation is very well tolerated, particularly if you have an adequate level of analgesia. When I designed my protocol, I did a pilot study of 5 patients; I was #3. I needed to be confident that it would work. It did.

My usual practice is to use propofol only, and get them deep enough so they don't move (but aren't apnoeic), then give a bit more when they show signs of stirring (or when I think it's about right). Different story for gastroscopes...

A fairly common technique. I would suggest that targetting movement oversedates most patients, and results in a fairly high rate of airway obstruction. I generally use pumps and look for stable control in colonoscopies. I use a coctail of propofol + remifentanil 10 mcg/cc + phenylepherine 40 mcg/cc. We call it "The Juice". I always preoxygenate using a Mapleson system (the M, because of my fondness for that letter). The average colonoscopy gets ~ 10 cc, and can walk to the PACU.
I also use straight sevoflurane ~1% end tidal for the patients with no IV access. Another controversy, but I figure a colonoscopy without an IV is less risky than an IJ cannulation without one. I've never seen a plaque pushed off the bowel directly into the brain, but the carotid is another matter.

And let's see - how much do you need to save to pay for one perforated bowel?

There is no support for the contention that bowels are perforated due to undersedation, in fact, there is considerable concern in the GI community that oversedation takes away the safety margin of stopping because something hurts prior to perforation. Most of the gastroenterologists I work with target amnesia and tolerate discomfort.

The bottom line on this is that colonoscopy reduces the mortality associated with colon cancer. We probably need to do 10,000,000 colonoscopies a year to maximally reduce colon cancer deaths. If I'm really efficient, I can do 20 cases a day. If I do nothing else all year I can probably do 4000/year. If I can get 2,500 anesthesiologists to do the same, we're set. Of course, that's 1/40 th of the anesthesiologists in the US. The numbers aren't much better for CRNAs. We simply don't have the number of providers to solve the problem, even assuming we wanted to spend half the budget available for cancer screening on anesthesiologists. We either have a two-tiered system, or develop new models for care delivery.

Anyone wanting to discuss this off-line can figure out how to get in touch with me. No flame wars.

 

[Planktonmd]

I think that patient controled anesthesia will ultimately be used as another method to replace anesthesiologists in GI procedures, and this study is just another step towards that objective, Thank you Dr. Mandel!

 

[JeffEMandel]

I don't see it as replacing anesthesiologists. In my institution, we cover less than 10% of the endoscopy cases. To book a case with anesthesia, the endoscopist must fill out a form specifying a reason - failure to sedate with conventional agents, intercurrent illness, etc. 90% are done with fentanyl & midazolam, benadryl for the hard cases. If someone has waited a month to get in with one of the experts who handle bad biliary strictures, submucous resections, or esophageal dilations, and they can't tolerate the procedure with 10 mg midazolam, 250 mcg fentanyl, 50 mg benadryl, and three RNs sitting on them, and one of the 5 anesthesiologists (out of a faculty of 50) who rotate through endoscopy isn't available, they go home, get rescheduled, and go through another bowel prep. So I don't see this threatening my job security.

As the process of providing anesthesia evolves, so will our roles. My CA-1 residents don't know how to keep a paper record, but are better than I am at completing the electronic record. Most of my anesthetics are TIVA done entirely by programming pumps - I joke that the only syringe I touch is the one on the ETT or LMA. Most of the monitoring is automated. There is a thread going on the Society for Technology in Anesthesia listserver about why no one listens to an esophageal stethoscope anymore. The need for an anesthesiologist to be physically present is diminishing, and at some point, we will cross a line in which we will function much more like ICU doctors than anesthesiologists.

We need to think about what the core skills of anesthesiologists are, and how we enhance patient care, rather than fighting to protect turf we aren't in a position to hold. I've never seen an anesthesiologist on Star Trek, but I'd like to think Star Fleet employs a number of them who sit at consoles at headquarters overseeing patient safety throughout the galaxy, while Dr. McCoy gets beamed down to the planet surface to do the grunt work. Not that I don't like travel and adventure...

 

[Gasboy07]

I appreciate what you're saying with regards to the study - and I'm interested to hear how broadly applicable your protocol is. What sort of patients are you dealing with? Relatively healthy elective scopes or fairly sick fat non-english speaking patients (ie the usual public bunch).

Also, what sort of work environment are you talking about? In the shoebox that we work in, we simply do not have the money to pay for the pumps and the monitoring that allow remote control monitoring.

As far as labour analgesia is concerned - I imagine you'd generally be present initially to load up - so 15mL (5+5+5) of 0.25 bupivacaine intravascularly or intrathecally would well and truly be noticed by the time you walk out the room. After that running 10mL/hr of 0.2% naropin is unlikely to be toxic.

I can see you'll say that would be similar to tailoring your sedation regimes so that adverse outcomes are minimised and that's a reasonable thing to do. And sure your GI people will tolerate amnesia rather than discomfort - does being awake enough to control the PCS mean you'll not be amnestic? In addition, I'm looking around for studies correlating pain and perforation and so far it seems that pain from perforation generally presents 4 - 24 hours later, so pain at the time of colonoscopy may not be a good indicator of complications.

More cynically, is this a money making excercise at the expense of patient comfort? After all, patient comfort and satisfaction should be our first priority, not sitting at consoles pressing buttons.

This is just a personal thing of mine, but nobody else follows a patient all the way from pre-op to recovery, and often afterwards on the pain service. It is our job to ensure the entire experience is as good as possible.

 

[Planktonmd]

It's not only about Endoscopies.
Very soon someone will decide to try patient controled anesthesia/sedation on other MAC cases : Pace makers, Port placement, minor surgeries.....
These procedures are very vital financially in private practice.
Then eventually Insurers will wonder: if the patient is controling the anesthetic then why do we need an anesthesiologist?
They will make standard protocols based on the data "we" provided, and they will put a nurse at the head of the table.

 

[Gasboy07]

I bet this well happen - because the cost benefit analysis will show (I'm sure it'll be manipulated to show) that it is cheaper to do it all patient controlled and accept that sometimes things go wrong, patients die and pay compo.

It's like for airlines it is cheaper for passengers to get killed than to be injured.

 

[JeffEMandel]

I appreciate what you're saying with regards to the study - and I'm interested to hear how broadly applicable your protocol is. What sort of patients are you dealing with? Relatively healthy elective scopes or fairly sick fat non-english speaking patients (ie the usual public bunch).

Ambulatory patients undergoing elective colonoscopy, mean age 59 (SD 10), BMI 28 (SD 6). Racial distribution was consistent with our general population.

Also, what sort of work environment are you talking about? In the shoebox that we work in, we simply do not have the money to pay for the pumps and the monitoring that allow remote control monitoring.

We are working on a paper on the economic analysis. Capital expenditures are offset by labor savings very quickly. I personally believe I can get CPAP machines for all the rooms if I can demonstrate that it will require one fewer CRNA. Recall that this is a hypothetical CRNA; we don't currently employ any CRNAs in the endoscopy suite, and the faculty who work there have plenty of other work.

As far as labour analgesia is concerned - I imagine you'd generally be present initially to load up - so 15mL (5+5+5) of 0.25 bupivacaine intravascularly or intrathecally would well and truly be noticed by the time you walk out the room. After that running 10mL/hr of 0.2% naropin is unlikely to be toxic.

Precisely. You have a lethal bag of medicine separated from the patient by a pump and a protocol.

I can see you'll say that would be similar to tailoring your sedation regimes so that adverse outcomes are minimised and that's a reasonable thing to do. And sure your GI people will tolerate amnesia rather than discomfort - does being awake enough to control the PCS mean you'll not be amnestic? In addition, I'm looking around for studies correlating pain and perforation and so far it seems that pain from perforation generally presents 4 - 24 hours later, so pain at the time of colonoscopy may not be a good indicator of complications.

I didn't collect this data formally, so I can't publish it, but I asked a number of patients how many times they pressed the button. No one came close to the right number. My personal experience was that I thought I'd had my procedure in 5 minutes, but it actually took 20 minutes. The discomfort was minimal, certainly nothing that would cause me to be apprehensive about going for a repeat colonoscopy.

More cynically, is this a money making excercise at the expense of patient comfort? After all, patient comfort and satisfaction should be our first priority, not sitting at consoles pressing buttons.

This is just a personal thing of mine, but nobody else follows a patient all the way from pre-op to recovery, and often afterwards on the pain service. It is our job to ensure the entire experience is as good as possible.

The gastroenterologists want to complete the procedure without having to have the patients restrained. They want the patients not to be phobic about a return visit. There are patients who demand total amnesia; I can only guarantee that with volatile agents.

One of the problems we have as anesthesiologists is that we don't see the public health implications of what we do. I see 55,000 deaths annually from colon cancer. I see that if I can increase the volume of colonoscopies done, both by greater facility efficiency, and by convincing people that colonoscopy is painless, and doesn't take 3 hours to recover from, I may save some lives. Of course, these are deaths I don't appreciate averting, since I'm not there in the hospice to watch them, but it benefits society. I don't see anything crass or venal in doing that.

 

[JeffEMandel]

It's not only about Endoscopies.
Very soon someone will decide to try patient controled anesthesia/sedation on other MAC cases : Pace makers, Port placement, minor surgeries.....
These procedures are very vital financially in private practice.
Then eventually Insurers will wonder: if the patient is controling the anesthetic then why do we need an anesthesiologist?
They will make standard protocols based on the data "we" provided, and they will put a nurse at the head of the table.

The third party payers already have criteria for what they will reimburse in MAC. It doesn't restrain us, so they are working on new sets of rules. There are incentives to push procedures out of hospitals to ambulatory surgery centers, and out of ASCs to office-based practice. The next set of rules are referred to unbundled payment for sedation; a portion of the professional fee is explicitly labelled for sedation. No one knows what the fee will be, but it won't be what it costs for a one-to-one provider. This will leave you with two options - abandon the business, or get more efficient.

The interests of patients are best served if we figure out ways to spread the benefits of anesthesia evenly across the system, rather than having 10% of the patients getting more anesthesia coverage than the need, and 90% only getting an anesthesiologist when someone calls code blue.

I've been on vacation this week, so I have time to answer these posts - next week I actually have to work, so if my postings trail off, it's because I busy.

 

[Planktonmd]

I am surprised that none of the other "usually very vocal" private practice guys on this forum is commenting on this subject.
Does that mean that you guys agree that patient controlled anesthesia is the way to go so our practice will adapt with the need of insurers to cut cost?