The Propofol Controversy
Propofol, a drug injected intravenously to sedate patients, gained national limelight as the drug that killed Michael Jackson. This is a distortion of the facts, as Jackson’s doctor had already administered a cocktail of intravenous Valium, Ativan and Versed—all powerful drugs in their own right—then added propofol to help Jackson sleep. Even though propofol was used incorrectly in Jackson’s case, it was enough to draw wide attention to this sedative agent.
For over 15 years, propofol has been in wide use for colonoscopies, a procedure that normally takes 30-60 minutes. There are other common uses for propofol, including
- The intensive care unit
- Patients who are intubated or on a ventilator (breathing tube)
- Very brief sedation (less than a minute up to 5 minutes) when emergency room patients must undergo a painful procedure such as cardiac shock or fixing a dislocated joint
- Physicians trained in critical care with equipment needed to deal with a complication.[i]
Aside from Michael Jackson’s death, propofol has a history of clinical controversy along three lines: 1) who should administer it; 2) the cost it adds to procedures; and 3) risks to patients.
Who should administer propofol?
Initially, injecting and monitoring patients with propofol was done by anesthesiologists, the clinical specialists responsible for sedating patients. With the dramatic rise in the number of colonscopies being done to screen for colon cancer, it became more practical and cost-effective to use specially trained nurses under the supervision of the endoscopist performing the colonoscopy. Not all states allowed this, however, and not all nurses were comfortable with the responsibility of administering propofol. One nurse wrote, “In my opinion, propofol should be administered for procedural sedation only by professionals with advanced training in the administration of general anesthesia and airway management. Propofol is very potent; even in skilled hands, patients can go from mildly sedated to obtunded [mentally dulled or unaware] in the blink of an eye.”[ii] In 2009, three gastroenterology organizations defended this practice, but the American Society of Anesthesiologists (ASA) strongly resisted. At the same time, the Centers for Medicare and Medicaid Services (CMS) issued guidelines on deep sedation that appeared to support the ASA’s position. More recently, anesthesiologist-administered propofol for colonoscopies is increasing, but data shows increased risk of complications for reasons yet to be determined.[iii]
Propofol adds costs
Injectable drugs like propofol are complex to make, but about six years ago a shortage of the drug drove prices up. At the time of the CMS guidelines, three companies produced propofol, but in 2009 two of the companies had to recall batches. The third company tired to make up the shortfall, but matters worsened when one of the other companies discontinued production due to losing a 2010 court case concerning possible hepatitis contamination. On the other hand, because propofol is now a generic drug, manufacturers no longer make much profit, so there is little incentive to make large amounts. Finally, it is more expensive to have the drug administered by anesthesiologists, who are MDs, rather than nurses, but currently that responsibility still rests with anesthesiologists. In short, propofol can add $600-2000 to procedures that are recommended for people over 50.[iv]
Risks to patients
Propofol works quickly and patients also awaken from it quickly. This is advantageous in emergency and critical care where immediate but brief life-saving procedures can be very painful. How it works is not fully understood, though it is known to slow brain-wave activity, and there are risks involved in its use. Cardiac and ventilator support should be available, especially for longer procedures. A rare but serious side effect is called propofol infusion syndrome (PRIS); PRIS may be caused by high doses or use for a prolonged period of time, and can be fatal.
Mental alertness may be compromised for a period of time after awakening; consuming alcohol or certain medications can increase this effect. Even without alcohol, there is a risk of delirium following a procedure in which propofol is used, with data suggesting the deeper the sedation (in other words, the higher the dose) the greater the risk of post-operative delirium. Longer-term compromised cognitive function (3 months or longer) has also been observed after use of propofol.
Patients who are allergic to eggs, egg products, soybeans or soybean products should not use propofol. Patients who have any of the following conditions should discuss with their doctor whether propofol is contraindicated for them: history of heart problems such as slow or irregular heartbeat, liver or kidney problems, high or low blood pressure, nervous system problems, lung or breathing problems, seizures, high lipid levels in the blood, inflammation of the pancreas, infection, fever, recent injury, or other signs of poor health.
According to John F. Dombrowski, MD, an anesthesiologist/pain specialist at the Washington Pain Center in Washington, D.C., “It’s only designed for people trained to do advanced cardiac life support… It induces a deep level of sleep and sedation, and it can cause your blood pressure to go down and your breathing to stop. You can die. Patients have to be monitored beat by beat, minute by minute.”[v]
Taking all this into account, it’s important to all of us at the Sperling Prostate Center to emphasize that we do not use propofol, or any general anesthesia, for focal laser ablation. Our patients do very well with local anesthetic to numb the nerves that control sensation in the prostate and prostate bed, similar to a dentist numbing the part of your mouth where dental work is to be done. We also provide a relaxant, such as Valium, so our patients are awake and comfortable while remaining responsive to direction during the procedure. In this matter, as in all others, we embrace the principle, “Above all else, do no harm.” That goes for anesthesia as well as the treatment itself.
[i] Benjamin Wedro, MD. “Michael Jackson’s Death: propofol (Diprivan) FAQ.” MedicineNet.com. http://www.medicinenet.com/script/main/art.asp?articlekey=105040
[ii] Thom Bloomquist, CRNA, MSN, FAAPM. “Letter: Propofol controversy.” Nursing2015. 2006 Aug;36(8):10-12
[iii] Cooper GS, Kou TD, Rex DK. Complications following colonoscopy with anesthesia assistance: A population-based analysis. JAMA Intern Med. 2013 Apr 8;173(7):551-6.
[iv] “Colonoscopy Anesthesia: Worth the High Price?” July 25, 2013. http://www.newsmax.com/Health/Health-News/colonoscopy-anesthesia-propofol-medical-costs/2013/07/25/id/517026/
[v] Matt McMillen. “Propofol: Expert Q & A.” WebMD. http://www.webmd.com/pain-management/features/propofol-faq