We are now going to transition to talks in the realm of procedures, but of course, there are no procedures without preparation for procedures. And so my talk as well as Sarah's next talk, which follows mine, will engage you on thinking and considering the details that are relevant to preparation for procedures. So my talk is entitled informed consent sedation and bowel preparation, because without getting patient consent without sedating the patient and if you're doing a lower GI procedure bowel preparation, you really can't do the procedure. I have no relationships to disclose. So the objectives of this talk are informed consent sedation and bowel preparation. Of course, that's the title and so let's be a little bit more specific, we need to define the elements of informed consent. Identify the process of informed consent and the responsibilities that are implied in its fiduciary nature, and to discuss the use of sedation and the spectrum of anxiolysis analgesia moderate sedation and deep sedation as well as general anesthesia to determine what type of sedation or anesthesia is required for endoscopic procedures and how they are administered. And then learn about the different types of bowel preparations that are available how to choose the most appropriate for the given situation and how to instruct the patient properly on their administration. So here we go. Let's start with informed consent. So it's important to remember first off that informed consent isn't just that paper or more and more that electronic pad that the patient signs prior to your undertaking their procedure. It's not just a document, it's actually an important process that has multiple key elements. The first of which is disclosure, you need to explain the nature of the procedure as well as the benefits the potential risks involved alternatives that might exist, and the limitations of the procedure because the procedure can't elucidate everything possible. So full disclosure is important, and it strengthens that relationship between the provider and the patient. When explaining the procedure, we use layman's terms we want to use words that the patient understands. It's generally accepted to be about the level of an eighth grade vocabulary. If the patient is not fluent in English, then you need a medical translator and you may not really want to rely on a family member or other potentially partial individual, but have an impartial objective medical translator, who is certified, either by institution or by an outside body to perform that function. It's important to encourage the participation of the patient. The patient may be shy or not want to engage in talking about the procedure because of anxiety about the procedure or whatnot. significant others family members friends that accompany the patient may alleviate that anxiety and lead to a better dialogue and ask questions, that's how you get a dialogue going and that's how you develop a rapport with the patient asked Do you understand the procedure. Do you have any questions. That's always an essential element to actually obtaining consent through the proper process of informed consent. Explain the possible risks to the procedure with some framework for incidents I've provided you with some, some numbers there with respect to the risk of adverse events for most endoscopies particularly for the diagnostic ones as you can see, the numbers are actually very low. When you start to add some therapeutic interventions or work in the pancreas or the biliary tree, or particularly invasive things like incisions that we make with placing a gastrostomy tube, then that rate starts to increase precipitously, but it's still very low when framed in the context of what the risks are for not performing the procedure which obviously isn't zero or the patient wouldn't be having the procedure so when most situations of a patient is sent for an endoscopic procedure they don't have a zero risk option to begin with, and sometimes framing it in that sort of context is actually more useful than just giving them numbers or ratios that they don't really know what to do with, or don't truly understand in the context of their clinical issue. It is also important to discuss the worst possible outcomes, although it's, again, important to frame this in the context of, well, what are the consequences of you don't have the procedure. Particularly with some therapeutic endoscopic procedures and patients that have multiple comorbidities or elderly have various medical issues already an adverse event a complication could result in the need for a blood transfusion surgery and admission to the hospital or the ICU or very remotely, the possibility of loss of life, but the risk of not doing the procedure obviously isn't a zero risk to begin with. It's important to discuss that no procedure is perfect that if you're doing a diagnostic procedure you may miss things. Because the pickup rate is not 100%. In those situations you'll want to have a witness, other than yourself to the consent. Oftentimes, another caregiver that you're working with another member of the team might be the most convenient person to be the witness. Ultimately, you need to document that process. And that's usually done with your signature and most importantly, that of the patient and that can either be on paper or an electronic equivalent. Moving on now to sedation. The objectives of sedation and analgesia are manifold. First off to relieve anxiety and discomfort for the patient. And to reduce pain. But also to improve the providers performance of an endoscopic examination, obviously a patient that's moving is very distracting or can be unsafe. And so it's important to have the patient well sedated, so that you can do a good job. So allows the endoscopist to concentrate on the actual endoscopic procedure and allows the nurses and the techs in the room to concentrate on the patient procedure documentation of the procedure and proper room turnover. The added advantage of reducing the patient's memory of the procedure and any potential emotional trauma from that is particularly important. When patients are presenting for endoscopy in the setting of a disorder or disease where they might have to have multiple endoscopies in the future. Even for a screening colonoscopy in the best of circumstances that patients got to come back in 10 years, you don't want them to have a bad experience this time, or that might reduce the likelihood that they will come back when they're supposed to for their next procedure so you want to prevent that. Different levels of sedation obviously some procedures can be done without sedation depending on the patient and the situation. You might provide minimal sedation or simply anxiolysis if that's all that's necessary. Moderate sedation is what we do most of the time for upper and lower GI endoscopy usually involving a couple of medication classes. Deep sedation and general anesthesia are usually limited to the hands of a, an anesthesia provider and anesthesia professional, whether that's the CRNA, or a physician anesthesiologist. Deep sedation is exactly the same thing as monitored anesthesia care many of us call that MAC anesthesia, general anesthesia requires endotracheal intubation and mechanical ventilation, and is often abbreviated GA. So status is important prior to the procedure you can't perform the procedure and a patient with a full stomach because the risk for aspiration, and everything bad that can accompany it. The goal is to minimize aspiration risk by not having the patient take anything by mouth for several hours before the procedure. The ASA guidelines dictate that they should be free of clear liquids for a couple of hours before the procedure and not take full liquids or solids for six hours. In some institutions with solids that may be as long as eight. And for patients who have existing known gastric emptying issues such as gastroparesis, or potential for esophageal retention of food and a kalasia or pseudo a kalasia. That may be an even longer wait. We do however want to continue essential medications with small sips of water. That's okay in any situation. And remember that emergency situations are not planned ones by definition. So those may alter these details, where the potential for benefit may exceed the risk. So structural risk benefits limitations and alternatives are not only important with regards to inform consent for the procedure, but also for any sedation or anesthesia that's going to be administered. That could be cardiopulmonary complications of sedation or anesthesia aspiration risk we just talked about risk of reactions allergies or otherwise to medications that are administered for sedation or anesthesia and risks for injury, etc. discharge once the patient is out of the recovery area, as well as risk for forgetting critical medication afterwards, because of the amnestic effect. That is the result of some of the medications that we utilize the pre procedural assessment is absolutely critical. With respect to the patient's respiratory status do they snore, do they experience strider apnea, go over the medications and allergies to meds, any adverse reactions to prior experiences with sedation and anesthesia, as well as their most recent oral liquid solid. As we just discussed, we want to know about tobacco, alcohol and substance use because these can be critical, both to respiratory issues, and also to the effects of sedation and anesthesia meds that are used. We want to make sure that they're accompanied by someone and have a solid plan for transportation after recovery because they absolutely cannot drive themselves home afterwards and really should have someone accompany them all the way to the door of their abode. Some document your vital signs the level of consciousness the Malum potty score, which I've provided a cartoon, as well as a classification for below for your use a heart and lung exam is absolutely critical. You want to know if there are any changes that occur from baseline during sedation or anesthesia and of course, if needed, and appropriate a pregnancy test pre procedure documentation of all of that is an absolute Joint Commission requirement document that pre procedural assessment, make sure it's documented. Before you administer any sedation or anesthesia. These are time documents, doing this after the administration of anesthetic agents or sedation is absolutely not adequate particularly could haunt you if there is any sort of an adverse event during or afterwards, and any sort of litigation that arises out of it, but timeout is imperative, this should be done before any procedures undertaken all activities need to stop. You should be undertaking a timeout to perform a final verification of the patient meaning identifying the patient, the procedure that's being done, where it's being done in the patient's anatomy, the sedation plan, and everybody on the team needs to voice agreement accordingly, and that needs to be documented. You're aware of the ASA classification. One is a normal healthy patient. Class two is mild systemic disease that doesn't limit activities such as well-controlled hypertension or well-controlled diabetes. Class three would be moderate or severe disease that doesn't limit activities such as well-controlled mild CHF. Class four or class five are patients with severe disease or who are moribund. These are patients that are anesthetized by anesthesia providers. Most of us are performing moderate sedation on class one, two, and three patients. Anesthesia assistance includes deep sedation or MAC anesthesia, as well as GA, as we said, prolonged or therapeutic endoscopic procedures such as EUS or ERCP often utilize deep sedation MAC anesthesia, so to speak, or GA. If there's anticipated intolerance to the standard benzodiazepines and opiates that are used for moderate sedation or the patient has advanced age or severe underlying disease or a known difficult airway or particularly sleep apnea, then anesthesia assistance may be wise and indicated. We do occasionally perform unsedated endoscopy. Patients tend to tolerate this more for colonoscopy than for upper GI endoscopy. These patients are generally carefully selected and many of them are patients who've done this successfully before, like the ability to be able to drive themselves home and go back to work the rest of the day. This is a consideration, however, know that you may need to convert to sedation, so it's wise to start an IV beforehand regardless, and of course, perform a pre-sedation evaluation and document that just in case you need to convert to moderate sedation or anesthesia. Monitoring is important. We already talked about the time out. We usually perform pulse oximetry, measure vital signs, do continuous lead monitoring for cardiac activity. You want to know the location of all of your resuscitation equipment, particularly suctioning equipment, an oral airway, the ability to bag the patient with an ambu bag and your reversal agents. It's important to observe the patient at all times carefully. Assess that patient before the procedure, decrease the dose or at least consider doing that for older patients. Assess that airway, be prepared for dosing deltas in these drugs in patients that are on psychotropic medications and substances, as well as opiates and benzodiazepines. There are potential adverse events in sedation. As we mentioned, there are local and systemic allergic reactions, skin reactions, et cetera. Desaturation is the most commonly observed one. Transient desaturation is actually frequent. You can usually reverse that with just upping the oxygen dose, but know how to escalate from there to a mask or a bagging administration of oxygen under positive pressure and how to get anesthesia support immediately if you need it. Moderate sedation, as we mentioned, is for class one, two, and three. Sedation is administered incrementally by the RN under the guidance of the endoscopist physician, and then the response is monitored by the RN, who's able to perform interruptible tasks in addition. We talked about the classes of drugs, benzodiazepines are mainly used to provide amnesia and minimize anxiety. Midazolam is what we use most of the time, the reversal agents, flumazenil, opioids, fentanyl is the most common thing that we use. We don't use a paradine or demerol so much anymore because of the potential for side effects. The reversal agent is naloxone, which, as you know, interestingly, also just went over the counter. Deep sedation is generally administered by an anesthesia professional, but can be administered in some states and areas by others, but I won't get into that in detail. Potential advantages for anesthesia provider administered deep sedation include improved patient satisfaction, decreased distraction for others performing the procedure, shorter sedation and recovery times. Potential disadvantages are mainly that it costs more to do it that way, and that there may be a slight increase in some studies in the risk of endoscopic complications. Purpose pearls, specifically in this area, pre-procedure assessment is essential. Do it and document it. The level of the sedation depends on patient and procedural factors, and informed consent should include a discussion of the risks of sedation and analgesia, not just the procedure. You can't do colonoscopy without a bowel prep, the timing of the preparation, the regimens available for cleansing, adjunctive measures, diet during bowel cleansing, and selection of bowel prep in specific populations are important aspects of this topic. If you remember one thing about this talk, please remember that split dosing for colonoscopy prep is absolutely the preferred regimen, and there is a lot of data underscoring the advantages. It improves tolerance on the part of the patient, and giving this the day before and the morning of the procedure leads to a better prep and better patient tolerance and satisfaction in the likelihood that they'll return for their next procedure. So what we do is we usually give it in the evening, the first dose beforehand. Half of the dose is given, and the other half is given the day of the procedure, three to eight hours before the procedure. You don't have to worry that giving it three to eight hours before the procedure the day of is going to lead to a higher risk of aspiration. There's data that shows that hospitalized patients prefer the split dose, and patients that are actually having an afternoon colonoscopy can take that entire prep in the morning if you and the patient prefer to do it that way, and the outcome will be just as good. We can use isosmotic agents, which is what are used most of the time. Hyposmotic agents can be used but are less frequently used. Hyperosmotic agents we've tended to steer away from, particularly in patients with renal disorders. Combination agents are also available. Isosmotic agents generally use polyethylene glycol or PEG-3350. This is a non-absorbable huge molecule, so basically the net volume that goes in is what comes out. Traditionally, it's a four-liter volume, so about a gallon, with a great safety profile and a long track record. We don't routinely use prokinetics or motility agents or enema, but in selected patients, this can be helpful to reduce nausea, vomiting, bloating, and cramping that can be encountered. The four-liter preps of PEG are usually go lightly and new lightly. The lower volume preps are MoviPrep and Planview. When we talk about lower volume, it's still going to ultimately, in terms of the total consumption, be about three liters, and so you're only saving about a liter. It does make it marginally more tolerable, and the efficacy is similar. The hyposmotic agents are generally low-volume PEG preparations. They require the addition of a sports drink to that PEG. This is not an FDA-approved prep, so we don't tend to recommend it. It's not equivalent to commercially available FDA-approved low-volume preps, but it's widely used, and the PEG-3350, of course, is Miralax, where it's generally equivalent. A hyperosmotic agent that is sometimes used is oral sodium sulfate. There's no significant electrolyte shift, which is why this is an advantageous agent. If you are going to use a hyperosmotic agent, it's well-tolerated because it's lower volume, and it compares well to other low-volume preps that are out there. Suprep is an example of a commercially available one. Magnesium citrate is hyperosmotic, and magcitrate can be used, but remember, it's not FDA-approved as a prep. It's FDA-approved as a laxative. One study demonstrated this to be superior to other low-volume preps, but be careful because it's excreted by the kidneys, and so you want to avoid this in elderly patients with lower kidney functions, those with kidney disease, and patients with cardiac disease who might not tolerate the electrolyte shifts. Other hyperosmotic agents include sodium phosphate, which really isn't recommended, sodium picosulfate combined with magcitrate, which is prepopic, and then sodium phosphate, magnesium citrate, and potassium chloride is a combination agent. With this, you're also going to want to be careful with patients who have renal and liver disease. Another combination agent is sodium sulfate, magsulfate, K-sulfate, and PEG. This is another low-volume prep that compares well to other low-volume preps, and so this can be useful for patients who have nausea and vomiting. Suclir is an example of that. Adjunctive measures include laxatives, flavorings, NG tube administration if the patient can't consume it orally well, particularly for pediatric patients, metoclopramide is sometimes useful for patients who have problems with gastric emptying, although the latest guidelines don't generally recommend that. Cymethicone can be used to eliminate bloating and can also reduce bubbles at the time of the procedure. Diet during bowel cleansing can include clear liquids and full liquids, as well as a low-residue diet to improve the outcome. Remember what we said about patients with advanced age or comorbid conditions. There aren't any specific recommendations for IBD patients or for bariatric patients, although with patients who have had a gastric bypass, you may want to consider a low-volume prep so that they can do a good job. With salvage options, there really isn't any evidence to recommend one strategy over another, and so you might think about the different options, and we can discuss this during our Q&A. As for failed prep and constipation, again, insufficient evidence to recommend a single salvage strategy, which requires intensive and extended bowel preparation in most instances and an initial low-residue diet followed by a clear liquid diet and is a 48- to 72-hour investment. Some pearls here, above all else, like I said at the beginning, utilize that split dose. The preparation choice, discuss that with the patient, consider a low-residue diet, and there are special considerations that we discussed, and there are ASGE guidelines at ASGE.org that are free for you to access. Access those frequently as they change time and again as our data rolls in. I wanted to share with you, you can look at these at your convenience. Dr. Bakari provided his instructions for patients with constipation in a split new lightly prep and also for a mag citrate new lightly extended prep for what his practice does at Rockford. Practice pearls overall for informed consent. Patient education goes a long way. Make that informed consent a dynamic process. Remember, if it isn't documented, it never happened, so document well. On the other hand, remember that consent isn't just that piece of paper. It is a process of disclosure and patient understanding. Ask questions. Sedation for GI procedures, follow that process from assessment through sedation and recovery to discharge, and with the prep, be diligent on colon preparation because you can't diagnose and treat what you can't see. Thank you very much, and I am now going to hand back off to Sarah Enslin, who's going to talk to us about the management of antithrombotics for patients undergoing GI endoscopy. Sarah?

informed consent

sedation

bowel preparation

risks and benefits

sedation levels

split dosing regimen