Recent development and expansion of endoscopy units has necessitated similar progress in the quality assurance of procedure sedation and monitoring. The large number of endoscopic procedures performed annually underlies the need for standardized quality initiatives focused on mitigating patient risk before, during, and immediately after endoscopic sedation, as well as improving procedure outcomes and patient satisfaction. Specific standards are needed for newer sedation modalities, including propofol administration. This article reviews the current guidelines and literature concerning quality assurance and endoscopic procedure sedation.
Key points
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Preprocedure assessment includes proper informed consent, a history and physical examination, risk assessment, a sedation plan, and a team pause or time-out.
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Intraprocedure time begins with sedation and ends with removal of the endoscope and includes guideline-based patient monitoring and complication management.
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The postprocedure assessment includes established discharge criteria, proper patient instructions, tracking of adverse events, and collection of patient satisfaction scores.
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Competency in procedural sedation includes formal training and education in sedation, an understanding of the pharmacokinetics and pharmacodynamics of sedation agents, and proper endoscopic personnel.
Introduction
With the rapid growth of endoscopic procedures, particularly in screening of colon cancer, the importance of patient tolerance and safety while conducting these procedures has also increased. Important for optimal performance and quality outcomes are a variety of medications for sedation and analgesia. Endoscopic sedation has traditionally included a benzodiazepine, most commonly midazolam, and an opioid analgesic, usually fentanyl. Propofol is an increasingly used sedative option through a variety of administration modalities and personnel. While the utility of the different sedation options and newer sedation modalities are explored, it is imperative that good quality-assurance measures be followed and competency maintained. This article reviews the endoscopic sedation and monitoring quality initiatives and guidelines in the current literature.
Introduction
With the rapid growth of endoscopic procedures, particularly in screening of colon cancer, the importance of patient tolerance and safety while conducting these procedures has also increased. Important for optimal performance and quality outcomes are a variety of medications for sedation and analgesia. Endoscopic sedation has traditionally included a benzodiazepine, most commonly midazolam, and an opioid analgesic, usually fentanyl. Propofol is an increasingly used sedative option through a variety of administration modalities and personnel. While the utility of the different sedation options and newer sedation modalities are explored, it is imperative that good quality-assurance measures be followed and competency maintained. This article reviews the endoscopic sedation and monitoring quality initiatives and guidelines in the current literature.
Quality-assurance competencies
Preprocedure Assessment
Before the endoscopic procedure, it is imperative that the safety of the patient be considered. Safety in endoscopic sedation can be categorized into several components, including but not limited to patient risk assessment, informed consent, monitoring compliance, training/education, and adverse event tracking. In addition, the American Society for Gastrointestinal Endoscopy (ASGE) recommends measuring preprocedure safety by how frequently certain issues are addressed, including informed consent, completion and documentation of a history and physical examination, risk assessment, development of a sedation plan, and performance of team pause or time-out. The essential steps for preprocedure assessment are discussed here.
Informed consent
Informed consent is a crucial component of all endoscopic procedures and adheres to the medical ethical principle of patient autonomy. It allows patients to be involved in their own care and creates the opportunity for each patient to ask questions and assist in decision making. With the exception of some emergent procedures, every attempt should be made to obtain and document proper informed consent before diagnostic and therapeutic endoscopic interventions. The discussion should include the sedation plan as well as the benefits and risks of sedation. Benefits include patient comfort and improvement of diagnostic procedure performance and therapeutic yield. Important risks include unintended deeper levels of sedation, suppression of respiration, postoperative somnolence, aspiration, and adverse reactions to sedation medications. Furthermore, the clinician who administers the sedation should personally obtain consent for sedation, and this should be done separately if the endoscopist will not be the sedation provider.
There does not seem to be any consensus on the exact timing and location for obtaining informed consent. However, the consent should ideally be obtained when there is sufficient time to explain and answer all questions in an environment that is comfortable for the patient.
History and physical examination
Each patient should undergo an assessment of medications, medical problems, and allergies, and a focused physical examination before sedation and endoscopy. This process should be done before the endoscopic procedure and thus should be separate from the endoscopy report. There should be a focus on identifying the potential complications from sedation and endoscopy, as well as the indications for the selected sedation. Specific history points that should be emphasized include previous sedation reactions (including both personal and family history of reactions to anesthesia), medication allergies, and potential medication interactions. Social history should incorporate any history of tobacco, alcohol, or substance use or abuse.
Risk assessment
Before sedation and endoscopy begins, each patient should be risk stratified to identify potential complications and adverse events. Objective methods such as the American Society of Anesthesiologists (ASA) score should be used to guide the sedation plan; this includes whether it is safe to proceed with the current plan with or without modifications and can be used as a screening tool for sedation.
The ASA score is a subjective assessment of a patient’s overall health and is based on 6 classes (I to VI):
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A normal healthy patient
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A patient with mild systemic disease
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A patient with severe systemic disease
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A patient with severe systemic disease that is a constant threat to life
- V.
A moribund patient who is not expected to survive without the operation
- VI.
A declared brain-dead patient whose organs are being removed for donor purposes
Sedation plan
Development and documentation of a sedation plan is required before beginning endoscopic procedures. Intended levels of sedation are categorized as no sedation, minimal sedation, moderate sedation, deep sedation, and general anesthesia.
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Minimal sedation that provides anxiolysis refers to a drug-induced state during which patients respond normally to verbal commands. Cognitive function and coordination may be impaired, but ventilatory and cardiovascular functions are unaffected.
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Moderate sedation (also commonly called intravenous conscious sedation) refers to a drug-induced depression of consciousness during which patients respond purposefully to verbal commands, either alone or accompanied by light tactile stimulation. No interventions are required to maintain a patent airway, and ventilation is spontaneous and adequate. Cardiovascular function is maintained. Moderate sedation is often used to perform endoscopic procedures.
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Deep sedation refers to drug-induced depression of consciousness during which patients cannot easily be aroused, but respond purposefully following repeated or painful stimulation. The ability to independently maintain ventilatory function may be impaired. Patients may require assistance in maintaining a patent airway, and spontaneous ventilation may be inadequate. Cardiovascular function is usually maintained. Deep sedation is also commonly used during endoscopic procedures, especially when propofol is used.
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General anesthesia refers to a drug-induced loss of consciousness during which patients are not arousable, even by painful stimulation. The ability to independently maintain ventilatory function is impaired. Such patients often require assistance in maintaining a patent airway, and positive pressure ventilation may be required because of depressed spontaneous ventilation or drug-induced depression of neuromuscular function. Cardiovascular function may be impaired. General anesthesia is less frequently used in general endoscopy, although it is often used in complex endoscopic procedures such as endoscopic retrograde cholangiopancreatography.
Physicians should be familiar with each level of sedation but should also be aware that these are levels of sedation within a spectrum. Physicians administering sedation to an intended level should also be trained for and comfortable with rescue methods, in the event that the patient enters a deeper than intended state of sedation.
Team pause
Also known as a time-out, the team pause is part of good patient care and is mandated by most national accrediting bodies, including the Joint Commission as well as the Centers for Medicare and Medicaid Services. The team pause should always be performed before initiation of sedation or insertion of the endoscope. During the team pause, patients should be asked to state their name and date of birth. The answer should be compared with the patient’s name band and verified with any documentation in the room, including the consent form, electronic medical health record, and the endoscopy reporting system. The procedure being performed should be noted and any specific equipment or concerns discussed. Any patient allergies should also be mentioned. The need for antibiotics or anticipated blood loss should also be noted when applicable. The team pause should be documented in the medical record. The team pause should be repeated if a new team member enters the procedure room after the initial team pause is complete.
Intraprocedure Assessment
Intraprocedure time begins with either sedation or insertion of the endoscope and lasts until the sedation is complete and the endoscope is removed. The administration and documentation of medications, frequency of reversal agent use, and rate of early termination because of adverse sedation issues are all integral quality indicators.
Monitoring
For the duration of the procedure, cardiopulmonary monitoring should be used to minimize adverse events. ASGE and ASA guidelines include use of pulse rate, blood pressure, and oximetry. The ASA also recommends continuous electrocardiography for patients with significant cardiovascular disease or dysrhythmias. Both ASGE and ASA guidelines recommend that capnography be considered for patients receiving deep sedation; however, only the ASA recommends using capnography for all patients undergoing moderate sedation. The ASGE states that there are insufficient data to mandate its use in all patients undergoing endoscopy with moderate sedation. Nevertheless, after publication of the ASA guidelines many endoscopy suites routinely include capnography monitoring. Transcutaneous capnometry to measure carbon dioxide has also been shown to prevent severe carbon dioxide retention more effectively than intensive clinical monitoring and pulse oximetry alone. Although not shown in controlled trials of endoscopy, it is generally thought that these monitoring modalities improve patient safety.
Complication management
Complications during endoscopy, although infrequent, are often related to the sedation rather than the endoscopic procedure. Complications from endoscopic sedation include phlebitis from intravenous benzodiazepine administration, hypoxemia, cardiac arrhythmias, and aspiration. The most common and serious complications are cardiopulmonary. Reversal agents are used to move patients to a lower level of sedation, typically when patients become oversedated and hypoxic. Naloxone is used to reverse the sedation and respiratory depression caused by opioids. Although flumazenil is used to reverse the sedation caused by benzodiazepines, it tends to have little effect on respiratory depression; because of this, naloxone should generally be given before flumazenil in the case of respiratory depression in a patient who has received both an opioid and a benzodiazepine for sedation. Caution should be used in patients who chronically take benzodiazepines, certain antidepressants, or antiepileptics because flumazenil administration can lower the seizure threshold. Of note, propofol has no currently available antagonist. It is important to recognize that the half-lives of the reversal agents are generally much shorter than the half-lives of the sedative agent being reversed. Thus patients need to be monitored after reversal until the effect of the sedative has worn off and for a minimum of 90 minutes.
At best there is negligible evidence in current literature to support the elective use of reversal agents to decrease recovery time and thus this elective use is not recommended. It is unclear whether there are cost-savings that are not outweighed by the cost of the routine use of these agents. Further, the issue of shorter half-lives of the reversal agents than the sedative agents could lead to resedation and possible complications.
Hypoxemia is common during endoscopic sedation. Moreover, some studies have shown a degree of hypoxemia in patients undergoing endoscopic procedures, even in those who are not sedated. Routine use of supplemental oxygen is recommended, especially in patients with risk factors for hypoxemia, which include above average endoscopic sedation dose administration, longer procedure times (eg, endoscopic ultrasonography), and patients with underlying cardiopulmonary disease. In addition, there may be a correlation with desaturation and arrhythmias, further supporting the benefits of routine supplemental oxygen use.
Postprocedure Assessment
The postprocedure period is typically defined as the time span from when the endoscope is removed to the first follow-up. Established discharge criteria should be met before each patient is allowed to leave, discharge instructions should be provided, adverse events should be documented, and patient satisfaction should be evaluated.
Discharge criteria
Every endoscopy center should have a preset list of criteria that must be met before patient discharge after endoscopy. There are 2 established grading systems that assess readiness for phase II recovery and home, respectively, that have been determined to be as safe as clinical assessment and facilitate faster discharge times: the Aldrete Scoring System ( Table 1 ) and the Postanesthetic Discharge Scoring System ( Table 2 ). If reversal agents were used, monitoring for at least 90 minutes after administration is recommended for signs of resedation. Although antagonist duration lasts approximately 1 hour, midazolam duration can last up to 80 minutes.
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