Anesthesia Patient Safety Podcast
The official podcast of the Anesthesia Patient Safety Foundation (APSF) is hosted by Alli Bechtel, MD, featuring the latest information and news in perioperative and anesthesia patient safety. The APSF podcast is intended for anesthesiologists, anesthetists, clinicians and other professionals with an interest in anesthesiology, and patient safety advocates around the world.
The Anesthesia Patient Safety Podcast delivers the best of the APSF Newsletter and website directly to you, so you can listen on the go! This includes some of the most important COVID-19 information on airway management, ventilators, personal protective equipment (PPE), drug information, and elective surgery recommendations.
Don't forget to check out APSF.org for the show notes that accompany each episode, and email us at podcast@APSF.org with your suggestions for future episodes. Visit us at APSF.org/podcast and at @APSForg on Twitter, Facebook, and Instagram.
Anesthesia Patient Safety Podcast
#249 Sugammadex Safety: Special Populations, Special Concerns
Discover the critical safety considerations when using Sugammadex, the seemingly "magical" neuromuscular blockade reversal agent that's fundamentally changed anesthesia practice. We delve deep into the science behind this medication and examine its use in three challenging patient populations: those with renal failure, pregnant patients, and pediatric patients.
For patients with kidney dysfunction, we explore the fascinating pharmacokinetics of Sugammadex and how its primarily renal excretion creates potential complications. With a normal half-life of approximately two hours extending to a 19 hours in severe renal impairment, understanding the risk of recurarization becomes essential. Despite these challenges, recent research suggests Sugammadex may still offer advantages over traditional reversal agents in these patients.
Pregnant patients present another complex scenario. Does Sugammadex bind to progesterone? What might this mean for maintaining pregnancy? We examine the current Society for Obstetric Anesthesia and Perinatology guidelines alongside emerging research that offers glimpses of hope for safe use. From animal studies to limited human case reports, we unpack what we know and the significant questions that remain unanswered.
The conversation extends to breastfeeding considerations and emergency scenarios where the risk-benefit analysis shifts dramatically. Through expert insights and references to the latest studies, we provide practical knowledge for anesthesia professionals navigating these challenging clinical situations. This episode serves as a crucial reminder that despite advances in pharmacology, patient safety still demands individualized care, vigilant monitoring, and thoughtful application of evolving evidence.
Want to further enhance your patient safety skills? Check out the Manual External Defibrillation course available at no cost through the ASA learning management system. Join us next week as we continue our discussion with a focus on pediatric patients and Sugammadex use.
For show notes & transcript, visit our episode page at apsf.org: https://www.apsf.org/podcast/249-sugammadex-safety-special-populations-special-concerns/
© 2025, The Anesthesia Patient Safety Foundation
You're listening to the Anesthesia Patient Safety Podcast, the official podcast of the Anesthesia Patient Safety Foundation. We're bringing you the very best from the APSF newsletter and website, as well as the latest information in perioperative patient safety. Thanks for joining us.
Speaker 2:Hello and welcome back to the Anesthesia Patient Safety Podcast. My name is Allie Bechtel and I'm your host. Thank you for joining us for another show. We are returning to the February 2025 APSF newsletter. Our featured topic today involves a newer anesthesia medication Cigamidex, and some important patient safety considerations. We are still learning more about this medication Cigamidex, and some important patient safety considerations. We are still learning more about this medication, so stay tuned.
Speaker 2:Before we dive further into the episode today, we'd like to recognize Prazinius Kabi, a major corporate supporter of APSF. Prazinius Kabi has generously provided unrestricted support to further our vision that no one shall be harmed by anesthesia care. Thank you, fresenius Cobby. We wouldn't be able to do all that we do without you. Our featured article today is Safety of Sugaminex in Pregnancy, pediatrics and Renal Failure by Kevin Yang, christina Rado, joseph Skokul and Ashley Ozumi. To follow along with us, head over to APSForg and click on the newsletter heading First. One down is the current issue. Then scroll down until you get to our featured article today. I will include the link in the show notes as well. To help kick off the show today, we are going to hear from one of the authors. I will let him introduce himself now.
Speaker 3:My name is Kevin Yang and I'm a current fourth-year medical student at the Keck School of Medicine of USC in Los Angeles, california.
Speaker 2:I asked Yang what got him interested in this topic. I'm a current fourth-year medical student at the Keck School of Medicine of USC in Los Angeles, California. I asked Yang what got him interested in this topic.
Speaker 3:Let's take a listen to what he had to say. The reason I became interested in this topic is my mother, who is a recently retired anesthesiologist. For most of her practice, succinylcholine was the preferred paralytic agent because it wears off so quickly, making ending a case pretty easy. However, most of the listeners will know that succinylcholine has some well-documented potential adverse effects. Now, a major shift in practice since then has been the introduction of sugamidex, which quickly and reliably reverses the neuromuscular blockade of non-depolarizing agents such as raw coronium agents, which do not have the adverse effects associated with succinylcholine. The use of Sugamidex and the way it has changed the practice of anesthesia since my mom practiced was a topic that piqued my interest, so I was excited when I had the opportunity to write this literature review investigating the safety of this relatively new drug.
Speaker 2:Thank you so much to Yang for helping introduce this topic. Do you remember the first time you used Sugamidex in clinical practice? Did it feel like an almost magical reversal agent? Sugamidex offers a quick and reliable reversal from neuromuscular blockade, but, lucky for us, it is not magic. It's science, and today we are talking about the safety considerations. We have talked about the 2023 American Society of Anesthesiologists ASA practice guidelines for the monitoring and antagonism of neuromuscular blockade on the podcast before. Remember. These guidelines recommend using quantitative monitoring instead of qualitative monitoring to help prevent residual blockade. Another recommendation is for the use of Sugamidex rather than Neostigmine, depending on the depth of blockade.
Speaker 2:The question is can we use Sugamidex safely for all patients? What about patients with renal failure, pregnant patients and pediatric patients? Let's check out figure one in the article for considerations of Sugamidex in special populations. First, for pediatric patients, sugamidex is approved for children two years old and up. There are no dosing guidelines for infants less than two years old and there is a risk for residual weakness and recurarization in this patient population. Next up, patients with renal failure. Did you know that Sugamidex is primarily excreted by the kidneys, plus rocuronium-Sugamidex complexes can disassociate, leading to recurarization. But keep in mind that Sugamidex may still be more effective than neostigmine to reverse cisatricurium in renally impaired patients. Finally, for pregnant patients, sugamidex interacts with progesterone and has a potential for teratogenicity. The use of Sugaminix is discouraged during breastfeeding.
Speaker 2:Now that we have shown you the trailer with all the spoilers, let's take a closer look at these special patient populations, starting with the safety of Sugamidex in renal failure. Here we go that for patients with severe renal impairment, there is a risk of recurarization, which may occur when circulating rocuronium-sugaminex complexes disassociate. In patients with normal renal function, the elimination half-life of sugaminex is about two hours, with an estimated plasma clearance of about 88 mLs per minute. Over 90% of the dose is excreted within 24 hours, with 96% excreted unchanged in the urine. There is an increased half-life of 4, 6, and 19 hours in mild, moderate and severe cases of renal impairment respectively. Roqueuronium and Sugamidex form a very stable complex due to intermolecular Van der Waals forces, thermodynamic hydrogen bonds and hydrophobic interactions. Did you know that for every 25 million Sugamidex-Rock uranium complexes, there is only one complex that dissociates? The complex is water-soluble and excreted in the urine in patients with normal renal function and removed by dialysis with a high-flux filter. Patients with severe renal dysfunction who are not on dialysis may be at risk, since the rocuronium-sugamidex complex stays in the plasma longer, meaning that there may be higher rates of disassociation.
Speaker 2:If you provide anesthesia care for patients with renal dysfunction, what is your plan for paralysis and reversal? One option is to administer a neuromuscular blocking agent and then wait for recovery of function. Another option is to use cisatricurium, which is not reversible with Sugamidex. And now it's time to check out the literature. There was a recent prospective randomized, blinded and controlled trial that compared Sugamidex and neostigmine for reversing moderate blockade in patients with with Renal Impairment. This is the 2024 study published in Anesthesia and Analgesia. Check out the show notes for the citation. The results revealed that Sugaminex administration led to a train-of-four ratio greater than 90%, significantly faster than Neostigmine, without major adverse events. It is likely that using Sugaminex to reverse moderate blockade is safe and faster than the combination of neostigmine and sesatricurium. And don't forget to use a quantitative neuromuscular monitor to ensure that your patients with renal impairment are adequately reversed.
Speaker 2:Now it's time to move on to our next patient population, so that you know what to expect when your patient is expecting. That's right. We are talking about the use of Sugaminex in pregnancy. Here's what we know there is no definitive data that demonstrates harm. At the same time, the Society for Obstetric Anesthesia and Perinatology, or SOAP guidelines, recommend against its use. These SOAP guidelines reveal the challenge in medical practice when there is a lack of conclusive drug safety data in pregnancy. That leads to conservative recommendations, and this may impact optimal management of pregnant patients who need neuromuscular blockade reversal. Now it's time for a literature review to find out what we have learned from recent studies.
Speaker 2:Sugamidex has the potential to bind progesterone. The initial manufacturer's model suggests potential binding to progestin, which means that there may be similar binding with progesterone. Follow-up in vitro studies have shown that Sugamin-X can bind to progesterone. Thus, in pregnant patients who need surgery, there is a concern that Sugamin-X can bind progesterone and thus decrease progesterone levels, which are crucial for maintaining pregnancy. The current preclinical data reveal the following A study in first trimester pregnant rats who received high-dose Sugamidex of 30 mg per kg showed no decrease in endogenous progesterone levels or any effect on live birth or stillbirth rates.
Speaker 2:Another study in pregnant rabbits who underwent general anesthesia with paralysis and reversal with Sugamidex showed significantly decreased progesterone levels. However, all the rabbit pregnancies were successful, without early births or stillbirths. A single case report describes a pregnant patient who had surgery for ovarian torsion and received Sugamidex without any pregnancy complications or side effects. Going forward, there is a call for more data and a registry which would allow anesthesia professionals to report on the use of Sugamidex in pregnant patients to help better understand and study the effects of Sugamidex on pregnancy progression.
Speaker 2:There is a concern that Sugamidex binding progesterone will affect obstetric outcomes. Decreased progesterone levels are associated with preterm labor and preterm premature rupture of membranes. There is a case series of 25 pregnant patients who received Sugamonex during the antenatal period with no obstetric complications directly related to the Sugamonex administration. The authors of that study attributed the lack of complications to the minimal placental transfer of Sugamnex and its high affinity for rocuronium, which may limit the progesterone binding. Keep in mind that Sugamnex has a half-life of about two hours, with clearance from the bloodstream within the first 48 hours, so it is likely that any potential side effects from progesterone binding would be seen within that time frame. For patients requiring cesarean delivery with general anesthesia, sugamidex has been shown to be safe and effective following rocuronium administration.
Speaker 2:There is limited evidence for the use of high-dose Sugamidex for rescue reversal in the setting of a cannot intubate, cannot ventilate scenario after rapid sequence induction. Current guidelines recommend considering using Sugaminex in this emergency situation, since the risk of severe hypoxia outweighs the potential risks from Sugaminex exposure. There are additional concerns about teratogenicity that came from cell culture studies that resulted in neuronal apoptosis due to oxidative stress, but later studies on mice with mature blood-brain barriers did not demonstrate this effect from exposure to Sugamidex. There are preclinical studies that demonstrated no adverse effects in pregnant rats. Preclinical studies that demonstrated no adverse effects in pregnant rats. While high doses in New Zealand white rabbits led to decreased fetal body weight and bone ossification issues without malformations, there is no evidence of these effects occurring in humans.
Speaker 2:Sugaminix molecules are large and polarized, which may limit the drug's ability to cross the blood-brain barrier as well as limit its excretion into breast milk. This is an important consideration when thinking about using Sugaminex for reversal during cesarean section or for any patients who are breastfeeding. Infants with immature metabolism and renal function may have delayed clearance if exposure to Sugaminex from the breast milk. There is one unpublished preclinical study in rats that demonstrated peak Sugaminex levels in rat milk 30 minutes after administration, with no adverse effects on offspring. There is currently no data on Sugaminex in human breast milk offspring. There is currently no data on Sugaminex in human breast milk. As a result, it is likely that breastfeeding should be delayed immediately after receiving Sugaminex, keeping in mind that peak concentrations may be one hour after delivery, with the potential for increased passage into breast milk during the early postpartum period Going forward, more information is needed to ascertain the risks and safety profile of Sugamidex use for pregnant and breastfeeding patients.
Speaker 2:This will help guide safe practices in obstetric and non-obstetric settings where the use of Sugamidex may be necessary and beneficial. We still have more to talk about in the article, but we are going to hear from the author once again. I also asked Yang what do you envision for the future with regards to this topic or area of anesthesia care?
Speaker 3:As we discuss in our literature review. Despite Sugamidex's now widespread use, the data regarding its safety in renal failure patients, pregnant patients and pediatric patients remains in its infancy. So I hope that the body of evidence regarding the use of this drug in those groups continues to grow so that we can better understand whether or not those groups can benefit from this drug in a safe way.
Speaker 2:Thank you so much to Yang for contributing to the show today. We are looking forward to continuing to discuss the safety considerations for Sugamonex use in clinical practice. Next week Spoiler alert we will be talking about the use of Sugamonex for pediatric patients. If you have any questions or comments from today's show, please email us at podcast at apsforg. Please keep in mind that the information in this show is provided for informational purposes only and does not constitute medical or legal advice. We hope that you will visit apsforg for detailed information and check out the show notes for links to all the topics we discussed today.
Speaker 2:Did you know that the Manual External Defibrillation, cardioversion and Pacing Technology Education Initiative is now available? What are you waiting for? This course offers eight topics to help you develop knowledge and skills to care for patients experiencing life-threatening advanced cardiovascular life support events requiring the use of a manual external defibrillator. Plus, you can encourage your colleagues, trainees and perioperative team members to complete the course as well. Did I mention that it is available at no cost and delivered through the ASA learning management system? Check out the show notes for a link to the course so that you can further develop your resuscitation skills to help keep patients safe. Until next time stay vigilant so that no one shall be harmed by anesthesia care. Thank you.