Plastic Surgery Practice - July 2009
Barry L. Friedberg, MD, on "Goldilocks" Anesthesia
by Connie Jennings
A medical pioneer discusses an alternative to general anesthesia for elective cosmetic surgery
The April 2009 issue of Anesthesiology magazine reported that 2,211 people died over the past 6 years due to anesthesia overmedication, and its editors thought that fact was not significant enough to warrant a feature article on the subject.
Currently, many anesthesia providers continue to work under the 20th-century concept of treating the brain response by overmedicating. They fear undermedicating patients. However, a safer approach to anesthesia for cosmetic procedures exists. It is new technology that has been scientifically validated and FDA-approved.
Millions of people undergo plastic surgery procedures every year. Some of those cases are restorative, due to accidental disfigurement, birth defects, or corrective secondary to a mastectomy or other operation that may have left them disproportional. The rest of these cases are purely cosmetic in nature.
Regardless of what leads one to have cosmetic surgery, it is almost always elective, with the vast majority of elective cosmetic surgery performed in the office. This requires the presence of not only the surgeon but a professional anesthesia provider as well. When a professional anesthesia provider enters the room, many patients get nervous—and with good reason. There are multiple adverse side effects that almost everyone experiences with general anesthesia. Likewise, there are many other side effects that are perhaps less common but far more serious.
One should know, at the onset, that general anesthesia requires the presence of an advanced airway, either an endotracheal tube or a tightly fitting positive airway mask, to maintain the airway once the brain is anesthetized. It takes away the brain's ability to tell the body to breathe on its own. It is not uncommon because the body is so relaxed during the anesthesia for the heart rate or blood pressure to become too low. This would require intervention such as increased fluid (via IV) or perhaps administration of even more drugs, such as vasopressors or stimulants for the heart rate.
The entire body is relaxed during the surgery—heart, lungs, and blood vessels included. This opens the door for further complications postoperatively. Number one on this list, and present in the widest population of patients undergoing general anesthesia for any reason, is postop nausea and vomiting (PONV). Additionally, most feel "hung over" and tired, weak, and may have a headache.
Because of the relaxing of the muscles during anesthesia, there is the increased risk of developing a blood clot somewhere in the body—the lungs or the legs being the most common places. It is also not uncommon to require blood pressure support or even ventilator support for a time after surgery due to difficulty waking up.
The advantage—the whole purpose, really—of having general anesthesia is to be pain-free physically, psychologically, and emotionally. No one wants to feel the pain of any surgical procedure, even one that is cosmetic in nature. And certainly, no one wants to remember any portion of the surgical experience that is not absolutely necessary.
No one considering elective cosmetic surgery wants to hear the information mentioned above. These are not emergent surgeries, life-or-death situations that require someone to take these risks without it being absolutely necessary. These are elective procedures that are often performed in the office of a cosmetic surgeon, or could be if there was little to no risk of these side effects or complications.
Barry L. Friedberg, MD, a pioneer in the field of office-based anesthesia—particularly in cosmetic surgery—has an alternative to general anesthesia for elective cosmetic surgery. According to Friedberg, his approach offers plastic and cosmetic surgeons a safe, effective way to have these procedures in the office and without the need for the advanced airways, vasopressors, extra fluids, or high-dose opioids that leave patients groggy and hazy. He says his alternative reduces the risk of PONV to almost nothing.
Since the introduction of Dr Friedberg's "PK Technique" in 1992, and the addition of using brain activity monitoring (BAM) to that technique in 1997, the rate of PONV and the postoperative complications of blood clots and pulmonary embolisms has plummeted.
In addition, Friedberg introduced the use of the Dinamap in 1979, and pushed for it to improve patient safety before it was a standard of care. Friedberg's stated purpose was to give physicians the tools to improve safety. He has also founded the nonprofit Goldilocks Anesthesia Foundation.
PSP: You refer to what I call bispectral index monitoring (BIS) as BAM. Why do you choose that?
Friedberg: I use BAM because that's the generic term for brain activity monitors, we are not trying to favor one product over another one … BIS is the leader … they're the ones who have invested the most in validating their technology … $30M or more for research. The competitors have not come up with any papers to say their product is any better. I try not to favor any one over the other. I don't have any financial relationship with any of them, and we use it because it it's a useful tool, not because there is any hidden agenda.
PSP: What prompted you to try the PK Technique? That is, how did you discover the advantages of the PK combo over general anesthesia?
Friedberg: I trained in Stanford in the mid-1970s and got to work with Dr Shumway, (cardiac transplant pioneer) and did open heart for about 5 years. I had my fill of that and moved on to less stressful work.
In 1988, propofol was introduced into North American surgery centers. From 1988 to 1992, I was just using propofol. It was only by the strangest of coincidences that I heard a  lecture by a gentleman named Charles A. Vinnik, a plastic surgeon. One of the founders of the AAAASF, Vinnik had published the secrets of using ketamines without the hallucinations in 1981. But unfortunately for the patients and for the anesthesia community, he published it in [a] plastic surgery magazine. This was only logical because he was a plastic surgeon. Of course, the big secret was that the diazepam was being given before giving the ketamine. The patient would lie still for the injection of the local anesthesia and would not hallucinate. I went to Las Vegas and watched what he did and found that he wasn't giving ketamine on a per-body-weight basis. He said the effect of the ketamine was independent of the body weight. Either you got the patient to be unresponsive or you didn't. It didn't have any relation to body weight.
In 1992, I didn't know what an NMDA receptor was. I'm not sure anybody today could tell you what they are. They are not many in number and they are found in the midbrain spinal cord, and, in fact, do not relate to body weight at all. All I did was take his recipe for putting the patient to sleep first, got rid of his diazepam, and started using the propofol.
There are other people who had been mixing the propofol and ketamine, but that is an entirely different concept. I explain by using the analogy of a martini and an olive on a stick. If you had a martini with an olive on a stick on the left and you took the olive off the stick on the right and run through a blender, you'd have a green-colored cocktail. Both could be described as a vodka and martini, but if you drank both side-by-side they would obviously be very different experiences. So, mixing the ketamine with the propofol is a very different effect than giving the propofol to a certain end point and then starting to administer the ketamine. This gives you a good visual analogy that proves all propofol and ketamine are not created equal.
Just the Facts
In more than 4,000 cases of all cosmetic surgeries from facelifts to abdominoplasties, Barry L. Friedberg, MD, has had no intubations and only a 1% to 2% use of LMAs.
In more than 17 years in practice, he has had no deaths and no hospital admissions for postoperative complications of blood clots, PEs or PONV, or excessive pain.
Friedberg's ideas for anesthetizing patients for elective plastic surgery are simple and straightforward: Medicate the brain, and measure it.
Friedberg has created controversy with his "Goldilocks" anesthesia initiatives, but that is not anything new for this medical pioneer. "It is easy to tell the pioneers in any field," he says. "They're the ones with arrows in their backs."
PSP: Why is it called the PK Technique?
Friedberg: It is called the "PK" technique because the propofol is given first. Prior to the BAM, I was using Vinnik's approach of titrating the propofol to the loss of lid reflex, which was common practice in anesthesia. This means you stroke the patient's eyelid and when they no longer blink or move their eyelid in response, they are assumed unresponsive. And then there's the other technique, a very tricky test, "Mrs. Smith, are you asleep now?" And if Mrs. Smith doesn't respond, then she's asleep. With the loss of the verbal response, you realize the patient is asleep, and then you give the ketamine. This ensures she won't hallucinate and will lie still for the injection of the local anesthesia, which is what cosmetic surgeons do all the time.
PSP: What advantages does using brain activity monitoring in conjunction with your technique offer to patients and professional anesthesia providers?
Friedberg: The goal for BAM is 60 to 75 for maintenance. The standard is for the BAM to be below 75 prior to giving the ketamine. You are not going to reach goal by bolusing with propofol based on body weight. You are going to give small doses. I call it incremental induction, typically 100 to 150 mcg/kg over 20 seconds on the pump. After one to three of those bumps—usually 1.5 to 2 minutes to gradually drift them to the 75 range on the BAM—the maintenance is 50 mcg/kg per minute.
Again, the advantage of the brain activity monitor is that we are using the patient's brain response to guide us. What the company doesn't tell you is to trend the EMG as a secondary trace. The BAM is 15 to 30 seconds behind the real time. The EMG is the electrical activity of the frontalis muscle and doesn't require processing in the algorithm, which is instantaneous. By following EMG activity you can proactively manage the case by responding to a spike in the EMG. It's fairly predictive of patient movement, so we can give more propofol and the surgeon can give more local on an as-needed basis. It gives you a heads up, so the [BAM] device is very useful.
If you're doing it the old way, you never look good and you're always playing catch-up. It's not a smooth thing, so why wouldn't you give general anesthesia? You can see the difference in how the case would look in the operating room using the BAM with the EMG tracing. The difference is in proactively managing the case and reacting to the patient rather than trying to play catch-up.
PSP: How did you change or "tweak" Vinnik's technique? How is the propofol/ketamine "cocktail" dosed appropriately?
Friedberg: Vinnik was doing what most people were doing in the 1970s, and that was giving diazepam (Valium). Valium and Demerol was a very common combination before fentanyl and midazolam came out.
What would happen is the patients would wiggle and squirm and they would cry out during the procedure, and then be given more local anesthesia so they wouldn't remember it. But it was a very barbaric way of conducting business. It was very unpleasant to be around.
Looking for something better, the anesthesiologist adjusted the dose of the ketamine. I guess the dose of 75 mg was a good dose for him. When I started the technique, I found that the 75 mg was too much. Empirically, I decreased the dose by 25 mg and started using a 50 mg dose. I tried 25 mg and found you could get a satisfactory level of unresponsiveness in 80% of patients with this dose, but also found that I was needing to re-medicate within the case; so I went back to the 50 mg dose and found that dose works pretty well for most adult patients between 90 and 250 pounds.
I made the conclusion that Vinnik was correct—the number of MDA receptors didn't vary based on weight. The same is true with ketamine. It has a checkered history due to its potential to cause hallucinations. There was the rub. In the early 1990s, people were not familiar with Vinnik's work but they were familiar with the bad side effects of the ketamine. Because of this, I was severely criticized for using the ketamine.
I began to log my cases in 1992. I logged them with great detail for 10 years. When I began writing about my experiences, I was able to [document] more than 2,500 patients.
PSP: Are the patients screened for preexisting liver/triglyceride conditions or other abnormalities that may contraindicate the use of the PK? Are these issues problems at all based on the time frame for which they are used?
Friedberg: These are really nonissues for the 17 years I have been using it in office-based anesthesia for cosmetic surgery. The average case is 2.5 hours. I've yet to run into a patient who has a true allergy to the suspension of the propofol or preservatives in it. I haven't given a bolus in 17 years. It is given in small quantities due to the interest in maintaining spontaneous respirations.
PSP: Your slogan, "Anesthesia Without Violence," is controversial.
Friedberg: The first 2 years I was in practice, the patients kept saying that the best part of the surgery was going to sleep. I couldn't figure it out: What do they mean? I finally realized that gentle is better than rough.
A classically trained anesthesiologist would give a bolus of propofol 1mg/kg to a basically healthy patient who walked in off the street to have cosmetic surgery. Given that dose of propofol, they are jerked from wide awake to completely unconscious. That's a violent act. What they were saying was that it was so nice to be put to sleep gently. After 2 years of listening to this, I finally understood it. I was going about my practice to maintain spontaneous ventilation, but what they were happy about was going to sleep gently, rather than roughly.
PSP: Your concepts continue to stir a good bit of controversy among the ASA.
Friedberg: Rapid induction is violent. In the context of emergency anesthesia, that is the last thing on your mind. You are trying to get a tube down the patient's throat to rectify a life-threatening emergency.
The problem is in office-based cosmetic surgery there are no emergencies. You are going to create the emergency by compromising the patient that you didn't know had a difficult airway by rapid induction. By using incremental induction, this can be avoided. If the patient didn't need your airway support the night before, they shouldn't need your support today. All the patients follow the same airway algorithm because they are never given narcotics or muscle relaxants, so the only thing that is depressing their respiratory effort is the propofol, which is introduced in a very gradual fashion. Thus, they are able to maintain spontaneous ventilation without the use of an advanced airway.
With regards to airway management in general anesthesia, for the most part we always give 2 mg of midazolam and 2 cc fentanyl initially. With this, you've already started depressing the respiratory drive and put the patient at a disadvantage by compromising their ability to maintain their own airway. My patients get 0.2 mg of clonidine preoperatively, so their catecholamines are back to normal and their respiratory drive is intact. It is an entirely different context than what most anesthesia providers can understand, so you can imagine I stirred up quite a bit of controversy.
PSP: What kind of feedback do you get from surgeons and professional anesthesia providers about your practice and recommendations?
Friedberg: [Regarding using a technique not taught in anesthesia school], people can't get their minds into a different frame to consider what you are saying—that you can do things differently and have not only the same positives but a lot less of the negatives involved with general anesthesia.
No oxygen for everybody? If they didn't need it before, go gently; they don't need it now. If you are using one respiratory depressant and monitoring brain activity, chances are that most of these people are not going to require additional oxygen.
Anesthesia colleagues who watch my cases on a 28- to 45-year-old patient having an abdominoplasty—who is otherwise generally healthy and nonsmoking—are dumbfounded. They see a 1,000-cc IV bag under their shoulders, the patient's head extended and turned laterally, and nothing in their airway—with oxygen saturations staying at 94% to 96% on room air.
They say, "How can this be?" Well, the BIS is 60 to 75; the patients are numb; they don't see, hear, or feel anything. They aren't guarding. You could give them extra oxygen or more drugs if you wanted to, but the patient's goals are being satisfied and the surgeon's goals are being satisfied. How much more do we have to give them?
The question from the colleagues is always the same: What's the trick? What did you give? The trick is always the same. What your eyes are showing is so much at variance with what you believe is required for an abdominoplasty that your mind refuses to accept what your eyes see. The psychologists have a neat term for this. It's called cognitive dissonance. That's why I never bothered to make a video of me doing an abdominoplasty on room air with spontaneous ventilation. People won't believe it. They don't even believe it when they see it live.
The Surgeon's Golden Rules
1. Propofol @ BIS 60 to 75 means the patient is adequately asleep, meaning he or she will not hear, feel, or remember the surgery.
2. A blanched surgical field does not guarantee complete analgesia.
3. Reinject the field if the patient moves with propofol @ BIS 60 to 75.
Dr Friedberg's notes:
These rules need to be explained in advance of surgery to the surgeon and away from the immediacy of the surgery; that is, not between physician and anesthesiologist over the ether screen or in the surgery lounge immediately prior to surgery (when the surgeon's mind is preoccupied with the surgery about to be performed).
These rules eliminate the fruitless argument about the patient being "too light" (irritated surgeon dialog) or needing "more local" (tired anesthesiologist response). Both are correct statements, as the patient "moves" or is "getting light" because he or she needs more local anesthesia.
The anesthesiologist's response should be to give a little more propofol while the surgeon injects a little more local in the immediate area in which he/she is working. More ketamine is not required, and massive reinfiltration is not required, either.
PSP: What, then, is your goal when using the PK technique with BAM?
Friedberg: The object is not to hurt the patients on the table, and don't give them drugs that make them sick to their stomachs. Then you have a tremendous formula for success. The propofol doesn't make them sick on their stomachs, and ketamine in the small quantities and under the specific context we defined does not allow the surgeon to hurt the patient when he introduces the local.
The BIS monitor serves two very important functions. It allows you to know exactly when it is safe to give the ketamine, so you don't get the bad side effects but you get all the good effects. It allows you to know during the case when to supplement more local.
The second of the three golden rules of the surgeon is that a blanched surgical field does not guarantee analgesia. This is the reason people gave up on IV sedation and went to general anesthesia for cosmetic surgery. There is epinephrine in lidocaine. The theory is that if the epinephrine effect is positive—blanching is present—then the lidocaine effects are also positive and the area is numb. Not true. The BAM allows you to differentiate between these two things.
In the old days, we used to have to treat every movement from the patient while they were under anesthesia as if it might be movement from the brain. Now you can differentiate between spinal cord movement and brain-related movement. You can treat the brain.
PSP: How can you differentiate between spinal cord movement and brain-invoked movement, and how does the BAM assist in this process?
Friedberg: When anesthesia was given through inhalation, it was based on research derived from studies done on rats—one group with a brain, one without a brain. The researchers realized that the movements were the same whether the rat had a brain or it didn't. What this proved was that these were spinal cord numbers, and they had nothing to do with the brain. If you see movement with no change in the BAM, and especially the EMG, you realize this is spinal cord activity and can be treated with local anesthesia that is more powerful than anything the professional anesthesia provider can put down the ET tube or in the IV. That is the power of the BAM: It allows the patient to get the most appropriate therapy at the moment. Monitor the brain, treat the brain.1 The most compelling reference for the use of brain activity monitoring can be found here.
PSP: Are there other professional anesthesia providers who employ the PK Technique with BAM?
Friedberg: Yes, there are a number of my colleagues who use the PK technique with brain activity monitoring. Some of them are Dr Marc Koch and Dr Rob Goldstein, both from New York; Dr Ray Hasel in Montreal; and Dr David Barinholtz from Chicago.
There is also a gentleman, Christopher Pollock, in Hull, England, who uses the PK technique, but without the BIS monitor. Additionally, the US Military actually uses the PK technique, but again, without the addition of the BIS monitor.
PSP: Are there changes coming in the way professional anesthesia providers are being taught today as compared to those of the "old school" ways of practicing? Specifically, will they be taught differences between practicing office-based anesthesia versus hospital-based anesthesia?
Friedberg: Office-based anesthesia is vastly different than hospital-based anesthesia. In 1996, I started the Society for Office Based Anesthesia so that people understand there is a profound difference in the office environment.
What has brought about the recognition of this difference is that enough patients have moved from outpatient surgery centers to the office to constitute a financial loss. That is usually how you get people's attention and get them involved. Now, programs around the country are struggling to figure out how to teach office-based anesthesia. They don't have any faculty who have practiced office-based anesthesia. My local university has accepted my offer to teach PK anesthesia, and I have been appointed an Associate Professor of Anesthesia at the University of California at Irvine.
My friend and colleague in Chicago, David Barinholtz, runs an office-based anesthesia company called Mobile Anesthesiologists. He has embraced the technique to a degree and uses the brain activity monitors as well.
People are finally getting the idea [office-based anesthesia is] here to stay, and it's a different environment. Your question is a difficult one to answer, but I think the answer is yes. Things are changing. Whether the universities accept it or not, the world is changing around them and they will have to respond. When they do, PK anesthesia will be part of it.
PSP: With such a widely documented decrease in adverse or avoidable side effects and complications in elective cosmetic surgery, why doesn't the ASA embrace the use of the PK technique and BIS monitoring?
Friedberg: The ASA is like the AMA—it is primarily a political organization that is dedicated to the economic welfare of their members. The primary goal is to take care of its economic interests.
The ASA is not encouraging the use of [the PK technique]. The textbooks that are coming out and the anesthesia programs are not teaching about the use of brain activity as a sound index of how to administer anesthesia. It is not in the interest of organized anesthesia to encourage the use of a technology that reduces the amount of drugs being used. By encouraging the use of the BAM, they would be hurting the people who help sponsor their activities. That's basically asking the fox to guard the henhouse.
Once the public understands there is an alternative to general anesthesia, they can ask for the use of this technology, be their own safety advocate, and can help change the system.
PSP: When Donda West died, it seems every discipline from the patient to the surgeon was questioned; that is, all but anesthesia. The mainstream media questioned her wisdom in choosing elective cosmetic surgery and the qualifications of the surgeon, but never the anesthesia provider. What does this say about the media and its ability to communicate to the public on life-and-death medical matters?
Friedberg: The public, like the media, need to be educated. We are able to get info from the BAM that is not available through the vital signs, the pulse oximetry, the EKG, or any other piece of equipment we use.
Tragedies and deaths almost always involve anesthesia and are almost always avoidable. Donda West is just another example of an avoidable death. The teenager in Florida who died [in 2008], Stephanie Kuleba, was undergoing surgery to correct asymmetrical breasts and an inverted areola. Doctors believe the cause of death was malignant hyperthermia, a relatively rare metabolic condition that can be triggered by certain anesthesia. A patient's heart rate and metabolism rises, causing the body temperature to rise to as high as 112 degrees. If MAC were used, an unknown issue such as malignant hyperthermia would not be encountered.
This death and these unnecessary risks would never be revealed without the use of general anesthesia in elective cosmetic surgery.
Going forward, we must do what is best for the patients in a very challenging environment and to keep them safe. General anesthesia is the most popular one in use because it is relatively technically easier, but it introduces risks that are just not acceptable in surgeries that are elective. In cosmetic surgery, you can't have risk/benefit discussion like with medically indicated surgeries. If you can get everything with PK that you can with general anesthesia without the risks, why wouldn't you do it?
Despite the availability of a better way and improved technology, professional anesthesia providers remain resistant to use it. This is based primarily on political reasons, not scientific. The system is slow to change. An estimated 20 to 30 million people per year get anesthesia without brain activity monitoring. Sadly, there is no good scientific reason for this.
PSP: Why do you campaign so heavily for the use of a technique using PK and BAM despite the controversy you spark and the flack you get from the ASA?
Friedberg: The only way to affect change is to educate the public, the media, and the anesthesia providers. It is about educating the patient to become his or her own safety advocate.
Connie Jennings is a contributing writer for PSP. She can be reached at PSPeditor@ascendmedia.com.
1. Court MH, Duan SX, Hesse LM, et al. Cytochrome P-450 2B6 is responsible for interindividual variability of propofol hydroxylation by human liver microsomes. Anesthesiology. 2001;94:110.