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Pre-procedural Considerations: Informed Consent, S ...
Pre-procedural Considerations: Informed Consent, Sedation, Bowel Preparation and Periprocedural Medication Management
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So before we do a procedure, we have to get ready for the procedure. And so this is preparation for procedure with all the things that are salient to that, including informed consent, sedation bowel prep, and periprocedural medication management. I have nothing to disclose. So the objectives of the entire talk are to discuss informed consent, sedation, and bowel preparation, as well as medication management, and to define the elements of informed consent, to describe the process of informed consent, the responsibilities that are implied therein, because we're there to act in the interest of the patient, and that's what they mean by fiduciary nature. To discuss the use of sedation and the spectrum of anxiolysis going all the way up to general anesthesia, determine what type of sedation or anesthesia is required for any particular endoscopic procedure and how they are administered, to learn about the different types of bowel preps available, how to choose the most appropriate one for the situation, and how to instruct the patient appropriately, and to discuss periprocedural preparation, including medication management. So let's start with informed consent, because you can't do anything unless the patient says that it's okay to do that. Let's start with a polling question. The informed consent process does not always include, A, a discussion about the procedure indication, B, a discussion of procedure-related risks, C, the written signature of the patient undergoing the procedure, or D, an opportunity for the patient or parent, or patient's guardian or parent, or power of attorney to ask questions. Which one is not always included in the informed consent process, A, B, C, or D? All right, very good. It's not always written, exactly. So informed consent's a process, right? It's not just that piece of paper that you sign and they sign. And it's important to talk about the concept of informed consent being a process, where it came from and why, and who can be involved. This actually goes back to history in World War II when things were done to people without them saying it's okay. And ultimately, it evolved to being proper patient care. You need to talk about the indications, i.e. the reason for the procedure, the risks and potential benefits, and the alternatives, if there are any, and what the risks are of not doing the procedure. It's important to cover the expectations, the potential for the procedure not succeeding, and what plan Bs exist if the procedure doesn't succeed. Most importantly, this is meant to be a dialogue. It's not just a lecture for the patient. So you want to ask them, may I answer any questions that you might have? A key element of this process is the disclosure of the following, the nature of the procedure, describe the procedure, its benefits, potential risks, alternatives, and limitations, just like we talked about. A full disclosure with an opportunity for dialogue is meant to strengthen the relationship between the patient and the provider. So we do this by explaining the procedure using lay terms. We don't want to use medical terms that the patient may not be aware of. Now, this is a bit easier if the patient is also a healthcare-related employee, if they are a provider, or a nurse, or a technician, and you know that, then you may be able to use medical language. But for most patients, you're going to need to describe things in understandable terms. And one way that I accomplish this is something that I enjoy, which is using analogies that somebody will understand because of their life experience, their education, or their training. Encouragement is important, participation of the patient is what's important in that dialogue. And also, if significant others, family, friends are there with the patient, engage them in the discussion, especially because the patient, when they return from the procedure, are likely to still be groggy and not be as participatory later on. It's important to build that rapport upfront. And be sure to ask them, do you understand the procedure and what we're talking about? If not, you may need to explain in a different way. And then, do you have any questions? Explain the possible risks. I don't tend to use numbers as much. You will see these in the literature. I try to use some analogies and use some words like very infrequent or unusual, and then couch the numbers within that sort of a qualitative description. And I find that the patient will understand better. Discuss the worst possible outcomes, but not in a way that's threatening or that scares a patient. That's not necessary as long as you explain it in a way that they understand that some of these things might happen, but that in general, they're very unusual. Furthermore, that in most situations, you can manage these worst possible outcomes very successfully. You also don't need to discuss the fact that our procedures aren't perfect and we might miss things that we went looking for because no diagnostic endoscopic procedure is 100%. Have a witness to the consent so that somebody other than you and the patient is there to witness the fact that the dialogue, that this process took place. And then that procedure is documented usually with a surgical consent form. This is an important document for you to know is available to you free online. The ASGE's guidelines are always available. You don't even have to sign into the ASGE website, ASGE.org. If you click under practice, you can easily get to the guidelines. In fact, it's actually a clickable button on the splash page for guidelines and they exist for informed consent like they do for so many topics. Go back and look at this frequently because these things get updated. Now let's move on to sedation. Start with a polling question. Levels of sedation include no sedation, minimal sedation, moderate sedation, deep sedation or all of the above, which is correct. All right, excellent. And I really wanted to point this out because sometimes you do give anxiolytic doses of medication, although that's not common. And there is the occasional patient who prefers to have a procedure done without any sedation so that they can drive themselves home. And that does indeed happen. So I just wanted you to be aware of that. Okay, here we go. Close that and let's move to the next slide here. So the objections of sedation, anesthesia, and analgesia are to remove or to relieve patient anxiety and discomfort, to improve the performance of the endoscopic exam because if the patient isn't moving around because they're uncomfortable, that allows all of us performing the procedure to do a better job and to provide 100% attention to the procedure. And we also want to induce some amnesia so that the patient doesn't remember being less than fully comfortable. The levels of sedation like we just talked about are either to give none or to have minimal sedation administered, which is anxiolysis, moderate sedation, which is what used to be called conscious sedation. They're not fully conscious, so we changed it to moderate sedation. And then deep sedation, which is usually with propofol, that's usually in most situations administered by an anesthesia provider. These days, very often a CRNA. And then general anesthesia, which is what the patient knows as being completely out where they need respiratory support with general endotracheal anesthesia so that they continue to breathe and there they are completely still. NPO status is something that does vary from unit to unit to some extent and with different types of sedation, sometimes largely related to who's administering it. The goal of NPO, being NPO before the procedure is to minimize aspiration risk. The anesthesia society usually says two hours for clear liquids, six hours for full liquids and solids, and longer if there's impaired gastric emptying for whatever reason, which these days is sometimes the result of medication like GLP-1 antagonists. I will say that some anesthesia practices say eight hours for solid food. Mine does that. So you're gonna wanna make sure that you're not just aware of the existing guidelines, but also know what tweaks exist within your own practice. Patients can usually continue essential medications with small sips of water right up to the procedure. We may alter these rules when it's an emergency situation, obviously, you gotta do what's best for the patient. So we talked about procedural risks, limitations and alternatives for the procedure, but this is also true for the anesthesia component. And in some practices, the anesthesia provider may want to get their own informed consent. That will be different from practice to practice. And they will usually talk about the cardiopulmonary complications risk, aspiration risk, the risk of medication reaction, or the risk of forgetting to take critical medications afterward if the patient is still not completely lucid, and then risks after discharge like falls and going up the steps to their front door when they get home, for example. We start always with a pre-procedural assessment. We wanna know whether they breathe well or whether they have respiratory issues like sleep apnea. We wanna talk about medications, drug allergies, adverse reactions to prior anesthesia, when they most recently ate or drank or took medication, substances that they use that may alter the response to anesthetics and analgesics and so forth. And to make sure that the patient is accompanied by someone who not only can drive them home, but someone who can actually walk with them and show them to their front door and get them into the house. It's not just the ride. Patients can get hurt stepping out of the vehicle, walking up to their house or into their door to sit down or lie down someplace in their home, particularly in areas where we experience inclement weather in the wintertime. There needs to be a pre-procedure exam documented that looks at the vital signs, level of consciousness, their Malampati score, et cetera. And this is depicted for you on the slide. The pre-procedure documentation that all of that was done as a joint commission requirement. You need to document that before the procedure, not after the procedure. And then a timeout needs to take place before the procedure starts. There is an ASA classification for patients. You're probably all aware of this. So I won't reiterate it. Most of the time, if we are sedating the patient, it's class one through three. And really, I don't think we're gonna be doing endoscopy on anybody who's declared brain dead. So you don't see a class six. Anesthesia assistance is usually for deep sedation, MAC anesthesia, as we call it, or general anesthesia. These typically are for the more prolonged or therapeutic procedures, but sometimes to increase efficiency in units where they have good anesthesia assistance availability. Can also be used when there's an anticipated intolerance or a lack of adequate sedation with the standard medications, midazolam and fentanyl, patients who are of advanced age or have severe underlying illness or a known difficulty or way. Unsedated endoscopy may be tolerated by some patients, particularly for colonoscopy. The benefit to the patient is that they can drive themselves home. And in some instances, that makes it worth it to a patient who can tolerate it. We usually do start an IV though, just in case we need to sedate the patient. So you need to ask the patient, if you don't tolerate it, can we sedate you? That's a good discussion to have before the procedure as well as again, during the procedure when you reach a point where the patient's not tolerating it without sedation. As for monitoring for sedation, get that timeout done. It involves pulse oximetry and then the other vital signs, continuous lead monitoring. When this is done, we always know where the rescue equipment is. There's no excuse for not knowing where all these things are to maintain an open airway and how to position the patient in a way to respond to airway compromise. This requires close observation of the patient regardless of who's doing it. Assess that patient before sedation. Decrease your doses for elderly patients or those with renal or liver function compromise. Assess that airway beforehand and be prepared for dosing deltas in patients who are already taking benzos, opiates, and other psychotropic medications because their dose requirements may be higher or they may have idiosyncratic reactions. Local and systemic allergic reactions, local skin reactions, oxygen desaturation, and hypotension are the most common adverse events that we see in sedation and we need to know how to respond to these. Moderate sedation is what used to be called conscious sedation but they're not fully conscious so that's not a great way to describe it. This is for ASA class one through three patients. This is medication usually fentanyl and Versed administered by the RN under the guidance of the endoscopist and the response including respirations is monitored by the RN who in some units may also be performing other interruptible tasks, which is considered to be acceptable. We use benzodiazepines because they have an amnestic effect and they reduce anxiety and we usually combine them with opioids, which reduce pain and again that's usually fentanyl and Versed dosed incrementally over time. There is also a concept of deep sedation which is usually administered by a nurse anesthetist or an anesthesiologist. There are some concepts and some regions where it is allowed for propofol to be administered by professionals who are not anesthesia professionals and you see that this is regionally dependent and in reality this is practiced very infrequently. When it's administered by an anesthesia provider, the advantages are improved patient satisfaction, decreased distraction for the endoscopy team where they can concentrate fully on the procedure at hand, as well as shorter turnaround time because shorter sedation and recovery times. However, there are disadvantages and that it costs more to do it this way. There's no demonstrated safety effect and there is possibly increased risk of aspiration, cardiopulmonary complications and perforations as a patient can tell you that they're feeling pain. So practice pearls for this part of the lecture pre-procedure assessments essential the level of sedation depends on many factors and informed consent needs to include a discussion of the sedation and analgesia and its risks as well. Let's talk about periprocedural medication management. This usually involves antithrombotics, blood thinners as you might know them that are either anti-platelet agents, anti-coagulants or many times these days patients are on both, especially those with coronary stents. Antibiotic prophylaxis has few indications in endoscopy. Some ERCPs peg placements and patients with upper GI bleeding who have cirrhosis. There's also glycemic control. We usually hold oral hypoglycemics the night prior or the morning of and we hold short acting insulin on the day of the procedure. More and more patients are on GLP-1 inhibitors and there is no blanket statement for what to do about these. Initially, the anesthesiologist used to recommend holding them for a week. But as we've gotten to see a larger number of patients over time in this situation, this is usually individualized and what's typically done is for the patients to have a clear liquid diet the day before. But if you have anesthesia providers, you need to ask them what their group's rule is. Generally, we consider other medications and continue other medications, including Tylenol. So there are some guidelines for you on our website for how to deal with antithrombotics. If the procedure itself is low risk for bleeding, then in many situations, it's okay to continue these. When to restart them depends on how necessary and what the indication is for the antithrombotic. With antibiotics, again, there are very few indications and I enumerated these before. And with EUSFNA, if we're dealing with mediastinal lesions or pancreatic cysts, or we have a PD patient, or if we're doing endoscopy in patients with heart valve prosthetics and there's active GI infection, those are a maybe for providing antibiotics. So again, this is from the ASGE guideline on this topic, and you can see biliary obstruction in the absence of cholangitis. We might give it if there's incomplete drainage of contrast. Mediastinal cysts, pancreatic cysts. Placement of a PEG, a cirrhotic patient with acute GI bleeding, peritoneal dialysis patient. That's really about it. Many of the old indications for antibiotics in endoscopy for prophylaxis no longer apply. And now moving on to bowel preps. What's important here is the timing of preparation, the regimen of cleansing prior to colonoscopy, adjunctive measures that might be required sometimes, diet during bowel cleansing, and selection of a particular bowel prep. I may call to your attention that there's a brand new set of guidelines that was just published this month by the ASGE jointly with the AGA and the ACG that you can easily find on any of the three websites of the organizations. In fact, you can just search it online, just pull up colon prep guidelines, boom, it'll show up from March of 2025, and you should refer to that document, which is kind of a pithy document, but a lot of what I'm going to describe to you applies. The guideline just underscores the fact that there's new data that they take into consideration that gives an even stronger basis for recommending what we're going to talk about. And good evidence for a split dose being the most effective regimen for a bowel prep improves patient tolerance. We give half of it the day before and the other half the morning of the procedure. It can all be given on the day of if the patient is done in the afternoon. So you can see specifically what this means, and I won't go through this below by below. There's different types of preps, isosmotic, hyposmotic, hyperosmotic, and combination agents that are available. Isosmotic agents, polyethylene glycol or PEG-3350, the stuff that's in Miralax and Golightly and Colite is the most common. Here, what goes in is what comes out, so they typically drink a four liter amount of this split, two liters the night before, two liters the morning of. This has a long track record and is very, very safe. You can add some other things if they're needed, but because of the high volume, the patient can become bloated or vomit or have nausea and abdominal cramping. These are isosmotic, so they don't tend to lead to fluid shifts. The high volume ones I mentioned to you, there are some low volume ones like MoviPrep and PlenVue, and the most recent guidelines actually recommend the low volume prep because it is better tolerated. Therefore, the compliance and the ability of the patient to complete the prep successfully is increased, so you should move to these. Hyposmotic agents, generally this is when you take Miralax that's meant for use for constipation and take it in conjunction with a commercial sports drink. Yeah, this is used widely, but it's not FDA approved, so it is not recommended because you're not controlling what actually is administered and gets done. It ends up having too many variables to be able to control properly. Hyperosmotic agents basically use hyperosmotic chemicals to suck fluid out of the body into the lumen of the gut. These can cause some electrolyte shifts, but certain ones that are marketed for preps and not for constipation end up resulting in no significant electrolyte shifts, although there are indeed electrolyte shifts because they're not significant, they're well tolerated, and they're also low volume type preps. And so they compare well to the other low volume preps and you see a couple of trade names listed for you there. Magsitrate is usually used for constipation and it's not FDA approved as a prep. These are excreted by the kidneys so you really want to avoid these in renal disease, elderly and cardiac patients, and probably avoid them and go for the aforementioned preps, anytime you possibly can, and avoid this old fashioned way of prepping patients. Sodium phosphate preps do cause a lot of fluid and electrolyte shifts, and these aren't recommended. Clenpic is a sodium picophosphate magnesium citrate low volume prep that's commercially available. It does, because of the sulfate and the magsitrate, result sometimes in nausea, vomiting and abdominal cramping, but is used in some practices. And there are combination agents that include an osmotic laxative as well as some tablets that are swallowed with water so that the prep is essentially mixed in the gut lumen. These can be well tolerated in some patients, you may want to avoid them in renal and liver patients. Suflav is a combination agent that includes sodium sulfate, magsulfate, potassium chloride, and PEG 3350 that compares well to other low volume preps and that's marketed as suflav. If patients aren't tolerating their prep, sometimes you can give them some metoclopramide Reglan to help move things through, but that can have its own side effects. Oral simethicone is now recommended in the latest guidelines to reduce the bubbling and frothing that can occur from bile retention in the colon. Flavoring agents such as powdered drink mixes can be sometimes added if the patient is not tolerating the prep very well. The diet during bowel cleansing is clear liquids, sometimes full liquids are okay, we want to avoid red ones, and around the time of the procedure, especially in patients who've had poor prep results before, go for a low residue diet. Know well what the patient can tolerate based on age and comorbid illness. There are no specific recommendations for patients with IBD or bariatric surgery, but if they have any sort of bariatric surgery, or you know they have bowel strictures and so forth, you may want to increase the length of time of the prep and use a low volume prep. There's no evidence out there enough to recommend a single salvage strategy in patients who fail their prep, we frequently give them a longer prep, sometimes have them get enemas or have them on a low residue or a liquid diet for a few days before if that's necessary, and increase the volume of the prep next time. So Perl split dose is the way to go, the guidelines tell you to do it because the evidence is good. You do have some choices, but some are better than others, you want to consider the ones that don't result in electrolyte and fluid shifts first. Consider a low residue diet to improve patient tolerance, and then remember the special considerations, the certain types of patients that you're going to want to be more careful in prescribing certain preps for and avoiding others, and consult those guidelines that just came out this month. I've included a couple of prep instruction forms that come from Drs. Vickery and Tawani's practice that I think are really well written that you can take a look at. Overall practice pearls for informed consent, remember patient education and a dialogue and asking if they have questions goes a long way, but you have to also document that the conversation, that the process happened, and that you have that witnessed. Sedation for GI procedures, follow the proper process from assessment through sedation, recovery, and discharge, and for the prep be diligent on colon preparation, because you can't diagnose what you can't see. Thank you very much.
Video Summary
The video outlines the critical steps and considerations in preparing for medical procedures, with a focus on informed consent, sedation, bowel preparation, and periprocedural medication management.<br /><br />Key points include the necessity of viewing informed consent as a comprehensive process, not just a formality. It highlights the importance of dialogue between the provider and the patient, discussing the procedure's nature, risks, benefits, alternatives, and potential outcomes. Encouraging patient participation by asking questions and ensuring understanding is emphasized. A witness should document the consent process.<br /><br />Sedation options vary from minimal to general anesthesia, with the choice depending on patient needs and procedure type. Pre-procedural assessment is vital for determining appropriate sedation, considering factors like age, comorbid conditions, and previous anesthesia reactions. Anesthesia can improve patient comfort and procedure effectiveness but has associated risks.<br /><br />Bowel preparation involves choosing appropriate cleansing agents, often favoring low-volume, isosmotic or hyperosmotic preps, which enhance patient tolerance. Follow split-dose protocols for efficiency. Considerations for special patient groups and managing medication before procedures are discussed, alongside emergency adjustment strategies.<br /><br />The video concludes by encouraging regular consultation of current guidelines to ensure the best practices in patient care and preparation.
Asset Subtitle
John Martin, MD, FASGE
Keywords
informed consent
sedation options
bowel preparation
periprocedural medication
patient participation
pre-procedural assessment
guidelines consultation
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