Now it's my great privilege to introduce my friend John Martin. He is a bit of an overachiever. He's with us for two talks back-to-back, and I know he'll do a great job. John Martin is a full-time practicing gastroenterologist at the Mayo Clinic in Rochester, Minnesota. In addition to his clinical practice and expertise, his interests center on endoscopy unit operations and efficiency, technological innovations in endoscopy, and endoscopic training and simulation in hands-on training and education. He has served numerous ASGE committees and previously served on the ASGE Governing Board. John currently serves on the ASGE Practice Operations Committee, so at this point, John, take it away. Joe, thank you very much. I sure do appreciate your kind introduction, and also would like to acknowledge Dr. Vickery for having written the initial iteration of this talk, upon a lot of which this information is based. So, a nod to you, Dr. Vickery. So here we go. Informed Consent, Sedation, and Bowel Preparation. This is the foundation upon which our endoscopic procedures rest. So while this is not the entree or the dessert, and is really more the vegetables, this is very, very important stuff. I have nothing to disclose. So the objectives are just as we mentioned, because these are important things, because our procedure and our capability to provide the best service depends on doing the legwork. So the objectives are to define the elements of informed consent, describe the process of informed consent, and the responsibilities implied in its fiduciary nature, to discuss the use of sedation and the spectrum of anxiolysis, analgesia, moderate sedation, and deep sedation, which is also called monitored anesthesia care, or MAC, and general anesthesia. Also to determine what types of sedation and anesthesia are required for endoscopic procedures and how they're administered, and to learn about the different types of bowel preparations available, how to choose the most appropriate for the situation, and how to instruct the patient properly on their administration. So let's start with informed consent, because that's where it all begins. And informed consent, importantly, is a process. It's not just that piece of paper that you're filling out and asking the patient to sign. The process has a key element, which is to disclose to the patient the nature of the procedure, its benefits, but also the risks involved so that the patient can participate in that risk-to-benefit calculation, the alternatives that are available to the patient, if any, and the limitations of the procedure. Remember that full disclosure strengthens the physician-patient relationship. Just as with any relationship, transparency is key. So with informed consent, first explain using layman terminology. This is frequently talked about as being an eighth-grade vocabulary level for someone who has a command of the language, but there are some patients who either don't speak or understand English or don't well, and there you have a need for a medical translator. And while a family member may actually perform that, it may be preferable to have an objective non-related person who can translate perform that function. It's important also to encourage the participation of the patient and significant others and family so that the patient feels supported to be actively engaged in the decision-making. Remember to inquire. Be sure to ask, do you understand the procedure? Do you have any questions? That latter one is most important. Ask the patient, do you have any questions? And answer those questions truthfully and transparently. Explain the possible risk of the procedure, but also some framework or providing context for the patient. Now, numbers are useful, but they're not always understandable by the patient. So you may want to couch those numbers by explaining what they mean. And for endoscopic procedures in general, they are low-risk procedures. And I think it's important to underscore that so that the patient isn't unnecessarily scared. But at the same time, you want to explain to them that while the risk is low, the risk isn't zero. And sometimes, even though all the process is correct, the outcome isn't what was expected or desired, and therein lies the issue of the risk of an adverse event. You can do everything you can to control the process and do everything correctly, but that doesn't necessarily mean that bad things can't happen. They certainly can. In endoscopy, in most instances, the relative risk of that is low. However, it isn't zero. Discuss the worst possible outcomes, but it's important to do this without scaring the patient. And those possible not desired outcomes include the need for ICU care, blood transfusion surgery, the removed possibility of death, et cetera. Discuss the potential for missed lesions. We don't see 100% of the surface of the mucosa in a colonoscopy. It's important to let the patient know that even if you do the best job possible, that doesn't mean 100%. Have a witness to consent if that's possible, and then make sure that that process is properly documented. Because as they say over and over again, if it's not written, it never happened. Now, let's move on to sedation and anesthesia. The objectives here are to relieve the patient's anxiety and discomfort, but also to improve the performance of the endoscopic examination. Because this allows the endoscopist to concentrate on the endoscopy and indeed perform it to the best degree possible, and also allows the nurses and techs involved to concentrate on the patient and the procedure as well, and also the documentation and room turnover that keeps your unit humming the entire day. They also serve to diminish the patient's memory, because any discomfort experienced isn't going to be a pleasant memory for the patient. And many of these patients have to go endoscopy repeatedly, and you don't want them to have a bad experience, because that will lead to them being more apprehensive or scared or uncomfortable the next time. There are different levels of sedation they need to be cognizant of. One is to perform the endoscopy with no sedation, which is occasionally done in patients who request and tolerate that well. There is minimal sedation, which is also known as anxiolysis, reducing the amount of sedation and anxiolysis, reducing anxiety, but not enough to reduce the patient's consciousness. Moderate sedation, which is what we tend to provide ourselves without anesthesia support, or deep sedation, which is also called monitored anesthesia care, or MAC, if administered by an anesthesia team in less common instances in other ways, which we will discuss. And then at the top end of the curve is general anesthesia, which is what you would think of as a patient undergoing anesthesia for surgery, where they are not only unconscious, but unable to breathe on their own and are ventilated mechanically. Patients need to be NPO for a certain number of hours before the procedure to minimize the risk of aspiration as a complication. The ASA guidelines, the American Society for Anesthesiology, requires two hours NPO for clear liquids, six hours for full liquids and solids. This may be lengthened if the patient has known delayed gastric emptying or achalasia, in which case they may retain food and liquid in their esophagus. Now, while these are the ASA guidelines, there may be institutional guidelines that are different from the ASA guidelines. For example, at my institution, our anesthesia department actually requires eight hours for full liquids and solids, and so I need to actually make sure that I and my patients abide to the eight-hour rule at Mayo Clinic as opposed to the ASA guidelines. Generally speaking, if your institution differs from the guidelines, it's going to be more stringent than the ASA guidelines, not less stringent. Patients can, on the other hand, continue essential medications with sips of water. Small sips of water are kind of like swallowing saliva, and we don't tell patients to quit doing that, so that's logical. Emergency situations obviously may alter these details, and that's a risk-to-benefit calculation, which you're probably already familiar with. Procedure risks, benefits, limitations, alternatives. Remember to discuss those with the patient and also from the standpoint of sedation, not just the procedure itself. Talk about the risks of sedation or anesthesia and the alternatives. Remember the possibility of cardiopulmonary complications, to discuss aspiration risk, the risk of medication reactions, risks after discharge, and the risks of forgetting critical medication afterwards. If you're performing endoscopy with an anesthesia provider, then they will typically take on this part of the informed consent, the anesthesia-related informed consent. However, if you're providing sedation, then you need to do this yourself. Pre-procedure assessment expectedly requires a brief history as well as an exam, and these, as you can see, are generally focused on respiratory issues. You're going to want to query them about sleeping habits, particularly with respect to snoring, stridor, and sleep apnea, medication and drug allergies, adverse reactions to sedation, anesthesia, other medications in the past. Sometimes not all of these have been properly documented, so it never hurts to ask. Most recent oral intake, confirm with the patient when they last had clear liquids, full liquids and solids. Ask about substance use and abuse. And then make sure that they're accompanied and have a solid plan for transportation post-recovery. Remember, they're not going to be driving themselves home after sedation or anesthesia. And you will want somebody to accompany them so that you reduce the risk of them falling and being injured or worse. The exam here should include, for sure, vital signs, a level of consciousness, the Malampati score, which you recollect has to do with their posterior pharynx, anatomy, and safety concerns with respect to apnea that can result from that, and airway obstruction, ease and difficulty of endotracheal intubation should they become hypoxic and need that. A heart and lung exam is imperative, and if needed, a pregnancy test. Remember the pre-procedure documentation. Getting all of this down in a written fashion is a JCO requirement, so document that pre-procedure assessment and document it before the procedure. Don't timestamp that thing after the procedure. You really want to avoid that for medical legal reasons and just from the standpoint of proper documentation. Observe a timeout before the procedure where everyone on the care team discontinues other activities to perform a final verification of the patient, name, date of birth, the procedure, what you're doing during the procedure, and the sedation plan. Remember your ASA classification. Class 1 is a normal, healthy patient. Class 2 is a patient with mild systemic disease that doesn't limit activities, say asymptomatic essential hypertension, for example, or hypothyroidism. Class 3 is moderate or severe disease that doesn't limit activities. Class 4 is severe systemic disease that's a constant threat to life. And Class 5, the patient is morbid and is at substantial risk of death within 24 hours. When you include anesthesia assistance, you're usually talking not about moderate sedation, but deep sedation or general endotracheal anesthesia. There's prolonged or therapeutic endoscopic procedures as the usual indication for this, although in some practices, even for routine screening colonoscopy, for example, anesthesia services will be utilized. But in cases where we almost never perform procedures without anesthesia input, these would include EOS with FNA, ERCP, and other interventional procedures, either because they're long or because they're complex or usually both. We also ask for anesthesia help when there's anticipated intolerance of the usual sedatives that we can administer for moderate sedation ourselves, sometimes if the patient is older or has severe underlying cardiopulmonary disease or have a difficult airway. Unsedated endoscopy is not done that often in North America anymore, but it can be done in carefully sedated patients who may tolerate it, have tolerated it in the past and ask for it. Sometimes patients want this because they don't want to be sedated, and they don't want the inconvenience of having to ask somebody to take time off to accompany them or drive them home or what have you. And if it's a simple upper endoscopy and they've tolerated it before, it's perfectly reasonable. Also for colonoscopy, some patients tolerate this well, and this can be considered. Pre-sedation evaluation should be performed and documented. This is standard. You never know if you may need to ultimately move on to sedation in these patients if they don't tolerate the procedure well. In some instances where it's questionable, you may go ahead and start IV access for this reason. Now when it comes to monitoring for procedural sedation, after you've done the time out, you've set the patient up for pulse oximetry. You're going to want to monitor on a constant basis, also their pulse, their blood pressure and respirations. That is standard. You're going to hook them up to a monitor and a pulse ox. You're going to perform continuous lead monitoring. You're going to know the location of resuscitation equipment. You want to know where that suction device is if the patient starts regurgitating or if they're secreting a lot in the oral airway, or rather in the oral cavity. Maintain their airway, their nasopharyngeal airway. If they're needing that because of obstruction, know where your ventilation or ambu bag is so that you can reach for it right away to recover their O2 sats and have reversal agents available at hand immediately if needed. Assess that patient before the procedure to determine the risk factors beforehand and understand your medication requirements. You're going to want to decrease that dose. In elderly patients, administer smaller doses, maybe more frequently, rather than gunning it with a large dose from the get-go. Patients who have renal dysfunction may also need dose reduction, as well as patients with hepatic compromise. Again, assess that airway with the Malampati score and with chest auscultation and be prepared for dosing Deltas in patients that are on benzodiazepines already. They may need higher doses, as well as opiates, same thing, and patients who are on psychotropic medications or substances may also require higher doses. Be aware of the complications that are possible from sedation, including local and systemic allergic reactions. Be prepared to deal with these. Local skin reactions are common. Arterial oxygen desaturation is also common and is often observed as an adverse event in sedated endoscopic procedures. Desaturation is frequent and readily reversed with increased oxygen administration. So know how to escalate that oxygen administration upward from nasal cannula to a mask and onward up the scale as needed. And know where all that equipment is, know how to use it, and know when to call for and receive immediate support from your anesthesia colleagues if things are beyond what you can control properly. Moderate sedation is for patients ASA class 1 through 3, not for more than that. Sedation is administered generally in increments by the RN under the guidance of the endoscopist physician. The response is monitored by the RN on a consistent basis, but that RN is allowed to perform interruptible tasks while providing that monitoring. Moderate sedation is usually a combination of administering benzodiazepines with opioids. Benzodiazepines are provided to minimize anxiety, provide amnesia. Most common one is midazolam, which you may know as Versed. We used to use diazepam. That tends to last longer, and so it takes patients longer to recover, so midazolam has become preferred. The reversal agent for benzos is flumazenil. With opioids, these are used to minimize discomfort and pain from the procedure. The most commonly used is fentanyl because it's fast-acting and fast-disappearing. We used to use mepiridine or Demerol, but this has side effects, particularly in patients with renal dysfunction, so the use has been disfavored over the past couple of decades. The reversal agent for opioids is naloxone. Deep sedation we generally don't provide ourselves, although in limited instances in certain states, non-anesthesia personnel-administered propofol or NAP is available, but in most areas this is regulated and not available. Just about everywhere what is available is MAC, or monitored anesthesia care, administered by anesthesia personnel, usually ACRNA. Additional advantages here, improved patient satisfaction, decreased distraction for the entire endoscopy team so that they can concentrate on the procedure itself, and shorter sedation and recovery times, increasing turnover of patients. But that does come at a cost as a separate charge for anesthesia. There is no demonstrated safety benefit. That doesn't mean there isn't a safety benefit. It's just that that safety benefit has not yet been definitively demonstrated in a high-quality study. There is a difference. There's also the possible risk of increased aspiration, cardiopulmonary complications, and viscous perforation that has been shown in some studies. So practice pearls for this section. Pre-procedure assessment is essential in selection of sedation and analgesia plan. The level of sedation depends on patient procedural factors. Informed consent should include the discussion of risks of sedation and analgesia, not just the risks of the procedure itself. Let's talk briefly about bowel preparation because colonoscopy is such a big part of GI endoscopy practice. Elements are the timing of the prep, regimens of colonic cleansing prior to colonoscopy, adjunctive measures, diet during bowel cleansing, and selection of bowel prep in specific patient populations. Split dose is the type of timing that is the preferred regimen now because of superiorities demonstrated in multiple studies. Get a higher-quality prep. It improves the patient tolerance. It's given the day before and the morning of the procedure. Specifically, the day before, the first dose is given early in the evening, and then on the day of the procedure, you give the second half, three to eight hours prior to the procedure itself. There's no difference in residual gastric fluid between split and single dose the day before, so it doesn't have that disadvantage. Hospitalized patients, the split dose is preferred, and in patients undergoing afternoon colonoscopy, they can actually take all of it on the morning of the exam. Different agents include isosmotic agents, hyposmotic agents, hyperosmotic agents, and combination agents. Isosmotic agents are generally PEG-3350, which is a large polymer of polyethylene glycol. There's no net absorption or secretion, so the volume that goes in is the volume that comes out. Traditionally, this means four liters or about a gallon, so it's a high-volume prep but has a good safety profile and a long track record of that safety. Prokinetics, bisacodyl, and enemas are not for routine addition but can be helpful in patients who haven't done well with the standard prep, but because this is large volume, it can be accompanied by nausea, vomiting, bloating, and abdominal cramping. So there are the high-volume isosmotic preps. There are the lower-volume isosmotic preps like MoviPrep and Plenview. These are a little more tolerable with a similar efficacy, so many practices, including ours, have moved to the lower-volume isosmotic preps. But there are also hyposmotic preps, which are low-volume polyethylene glycol preparations that require the addition of a sports drink. Now, these are not approved by the FDA to be used for bowel preps, so this is Miralax along with a sports drink. They're really not considered to be equivalent to other low-volume preps, but they're widely used because patients like them. There are hyperosmotic preps, which are generally oral sodium sulfate, which are well-tolerated, don't induce an electrolyte shift that's significant in most patients who don't have significant renal dysfunction. And their performance compares well to other low-volume preps. A good example of this is SuPrep. There are also magnesium citrate preps. These are not FDA-approved for the colon prep indication. One study found that mag citrate was superior to other low-volume preps. This is excreted by the kidneys, though, so you want to avoid this for patients with low renal function, such as people with renal disease or elderly and cardiac patients. There are also sodium sulfate preps, which are other low-volume preps that are no longer recommended. There are combination agents that combine sodium picosulfate with magnesium citrate. So sodium picosulfate is a stimulant laxative. They combine this with an osmotic laxative in the form of magnesium. These compare well in performance to other low-volume preps. They're well-tolerated, but produce some abnominal cramping, nausea, and vomiting. An example of this was prepopic, which actually was discontinued. There's another one that's not in a powder form that is already as a mixed liquid form, which is available. Sodium sulfate, magnesium citrate, potassium chloride preps are also available and given in this form, which I won't go into in detail. And I'm going to skip the sodium sulfate, mag sulfate, potassium sulfate, PEG-3350. Sue cleared detail. These are just a number of different preps that you can use. There are adjunctive measures, such as laxatives, flavorings, administering through an NG, where patients can't drink this stuff quickly enough, adding prokinetic agents like metoclopramide in patients who have slow gastric emptying, and simethicone for patients who have bloating to help patients tolerate the larger-volume preps better. It can help to put the patient on clear liquids ahead of the prep, particularly if you've known, if you know that they've had poor preps before. And you may want to do full liquids or low-residue diets in people who have had solid food residue after a full prep demonstrated in the past. You may want to use special considerations in patients who have advanced age or comorbid illnesses. Patients who have IBD, we have no specific recommendations with prep for them. Same with bariatric surgery, although you may want to consider low-volume preps in these patients since they don't have a large stomach reservoir to accommodate drinking a lot of fluid volume quickly. When patients have inadequate prep performance, you may want to salvage. You're going to have to do some experimenting with this, although some institutions have their own guidelines for this. You may administer on the day of the prep an enema, or a day of the procedure an enema, or through the scope enema, or additional bowel prep like another liter or two. With a failed prep in patients who have constipation, there really isn't good data to tell you what to do there. You may want to extend their prep for a longer period, like 72 hours, and add a low-residue diet or a clear liquid diet for a prolonged period of time. For preps, split that dose. That's the way to go now. That is the preparation of choice, split dose of the prep. Administer a low-residue diet or low-residue prep to improve patient tolerance. Remember those special considerations we mentioned for patients with certain conditions. Always consult with ASGE guidelines, which are free for you online at asge.org at any time free of charge. Dr. Vickery included some nice prep guidelines for you from his practice, so these are available for you on the slide deck in GI Leap. And overall pearls for this entire endoscopy procedure preparation lecture, for informed consent section, patient education goes a long way toward a successful procedure and a trusting patient-provider relationship. Make informed consent a dynamic process. It's a process, not just a document. Remember, if it isn't documented, it never happened. And on the other hand, remember that consent isn't just that piece of paper. It's a process of disclosure, transparency, and understanding between you, your team, and the patient. For the sedation section, follow proper process for assessment through sedation and then through recovery and patient discharge. And for the prep part, be diligent on colon preparation. You certainly can't diagnose what you can't see. Thank you very much.

John Martin

gastroenterologist

informed consent

sedation options

bowel preparation

endoscopy procedures

patient safety