Sedation and Analgesia for Diagnostic and Therapeutic Procedures – Part 3 pptx

Practice Guidelines 55 55 Table 1 Continuum of Depth of Sedation Definition of General Anesthesia and Levels of Sedation/Analgesia* Moderate Minimal sedation sedation/analgesia Deep General (Anxiolysis) (“sonscious sedation”) sedation/analgesia anesthesia Responsiveness Normal response to Purposeful ** response Purposeful** response Unarousable even verbal stimulation to verbal or tactile following repeated or with painful stimulus stimulation painful stimulation Airway Unaffected No intervention Intervention may Intervention often required required be required Spontaneous Unaffected Adequate May be inadequate Frequently inadequate ventilation Cardiovascular Unaffected Usually maintained Usually maintained May be impaired function Continuum of Depth of Sedation ©1999 website (http://www.asahq.org/standards/20.tm) and is reprinted with permission of the American Society of Anesthesiologists. * Monitored Anesthesia Care does not describe the continuum of depth of sedation; it describes “a specific anesthesia service i n which an anesthesiologist has been requested to participate in the care of a patient undergoing a diagnostic or therapeutic procedure.” ** Reflex withdrawal from a painful stimulus is NOT considered a purposeful response. 56 Steadman and Yun The JCAHO states that “the standards for anesthesia care apply when patients receive, for any purpose, by any route, sedation which may be reasonably expected to result in the loss of protective reflexes” which the Accreditation Manual for Hospitals defines as the inability to handle secretions without aspi- ration or to maintain a patent airway independently. The Commission’s Accredi- tation Manual points out that it is “not often possible to predict how a patient will respond to sedation” (12). 4. PERSONNEL/PRIVILEGING Studies have not yet determined whether the number and training of staff affects patient outcomes. However, the JCAHO and the ASA Task Force appreciate that an individual who performs a procedure cannot adequately monitor a patient’s condition. Both organizations agree that the minimum number of personnel required during procedures in which sedation or anal- gesia is administered is two—the individual performing the procedure and the individual monitoring the patient. Both providers should be practicing within their scope of practice as defined by law and hospital policy. One of the two providers must be a licensed independent practitioner (physician, podiatrist, dentist, or oral surgeon) with legal authority to administer con- scious sedation. The licensed independent practitioner has primary respon- sibility for patient care, for sedation/analgesia medication orders, and for the supervision and management of the patient’s response to sedation. The health care provider monitoring the patient may administer the sedative and/ or analgesic medication under written or verbal order from the licensed inde- pendent practitioner if their scope of practice permits. During conscious seda- tion, the provider monitoring the patient may assist the operator as needed, with brief, interruptible tasks. During deep sedation, this is no longer the case, and a third individual is required if the operator needs assistance (13). 4.1. Training Health care providers involved in the administration of sedation should be trained in clinical pharmacology and in airway management. Specific concerns of the ASA Task Force regarding safe drug use include the poten- tial for drug combinations to potentiate respiratory depression, too-frequent dosing resulting in a cumulative overdose, and a lack of familiarity with sedative and opioid antagonists (4). Airway management training should focus on establishing a patent airway and maintaining oxygenation and ven- tilation using positive pressure. Additional resources, such as respiratory support equipment and a practitioner skilled in tracheal intubation and advanced life-support, should be readily available. During procedures involving deep Practice Guidelines 57 sedation, the need for airway management training is greater, and a higher level of skill should be required prior to privileging. 5. EMERGENCY EQUIPMENT Numerous reports support the fact that respiratory depression and apnea can occur as complications of sedation. Iber reported 10 episodes of apnea or cardiopulmonary arrest, primarily involving patients over 60 years of age, during the performance of 10,000 endoscopies (14). Bailey noted that 78% of the 80 deaths reported after the use of midazolam were respiratory in nature; many of these were precipitated by concurrent opioid administration (15). These and other reports of respiratory events suggest that the availabil- ity of emergency equipment will reduce the risk of an adverse outcome dur- ing sedation. Equipment should be immediately accessible, and in good working order, and should meet the needs of the particular patient popula- tion served—e.g., adult or pediatric. Such equipment includes a self-inflating positive-pressure oxygen delivery system with appropriate sized masks, a vacuum source, suction supplies, oxygen source and delivery equipment, tracheal intubation supplies, resuscitation and reversal medications, an elec- trocardiographic monitor, and a defibrillator (Table 2). The ASA Task Force noted that there is insufficient evidence to support the need for defibrillators, yet strongly supports their availability. Standard physiologic monitoring equipment is discussed in Subheading 7. Table 2 Equipment Needs for Sedation/Analgesia Present at the location • Pulse oximeter, automated blood pressure cuff, temperature monitor (patients < 5 kg) • Suction • Oxygen source and appropriate delivery devices (nasal cannula, face mask, non-rebreathing mask) • Bag-valve-mask devices with appropriate masks • Reversal agents as appropriate to the drugs administered Immediately available • Defibrillator • EKG machine • Intubation equipment • ACLS drugs and procedural equipment • Personnel adequately trained to provide ACLS 58 Steadman and Yun 6. PATIENT CARE: PRE-PROCEDURAL ASSESSMENT A recent (per medical staff policy) history and physical examination by a physician and an assessment by the qualified health care provider adminis- tering the sedation/analgesia must be available prior to each procedure in which sedation/analgesia is given. This assessment should include the patient’s age, any known allergies or drug reactions, current medications, tobacco, alcohol or substance use, current health problems, and review of systems with specific note of any airway or cardiopulmonary problems. Additionally, the patient’s last food intake should be assessed for compli- ance with institutional policies for elective procedures. The physical exami- nation should include vital signs, weight and height, an airway and sedation-directed evaluation, and a risk stratification using the ASA Physi- cal Status classification (Tables 3, 4). The risk assessment allows outcome monitoring (a JCAHO requirement) to be stratified by pre-existing illness. Finally, the patient should be informed of the benefits, risks and alternatives to sedation as part of the planned procedure (Table 5). 7. MONITORING AND CARE DURING THE PROCEDURE During the procedure, the patient’s heart rate and oxygen saturation should be continuously monitored; the level of consciousness, blood pres- sure, and respiratory rate should be monitored intermittently at a frequency determined by the depth of sedation/analgesia. Because the risk of loss of protective reflexes, the monitoring of intermittently assessed variables should be more frequent during deep sedation than the minimum require- ment of every 15 min for conscious sedation (16). The same monitoring and documentation frequency during deep sedation as during general anesthe- sia—every 5 min during the procedure—is used by some hospitals even for conscious sedation (2). Table 6 contains recommendations for the frequency of monitoring during sedation/analgesia. 7.1. Level of Consciousness Level of consciousness monitoring assures a level of patient responsive- ness sufficient to maintain an open upper airway and gag reflex. Patient responsiveness allows an assessment of the effect of previously adminis- tered sedative and analgesic agents and assists in determining, along with the drugs’ pharmacokinetic profile (time to peak effect), whether further titration of sedation/analgesia is required. In procedures in which the patient’s verbal response is precluded, such as endoscopy, an alternate means of signaling responsiveness such as a “thumbs up” sign should be used. Seda- tion administered for procedures, in which lack of patient motion is desired, Practice Guidelines 59 such as MRI, carries a higher risk, particularly in uncooperative patients. Drugs and dosing schemes used during such procedures should have a wide margin of safety. 7.2. Pulse Oximetry Oxygen saturation monitoring has been extensively studied under a vari- ety of conditions. Oral surgeons (17,18), plastic surgeons (19), interventional radiologists (20), endoscopists (21), and colonoscopists (22) have all noted clinically significant hypoxemia diagnosed by pulse oximetry before “clinically detectable signs of respiratory depression” (20) and earlier than with other Table 3 Pre-Procedural Assessment History A recent (per institutional policy) H&P by a physician An assessment by the health care provider administering the sedation/analgesia prior to the procedure Patient age Allergies or drug reactions Current medications Tobacco, alcohol, or substance use Current health problems Review of systems with specific note of any airway or cardiopulmonary problems Last food intake assessed for compliance with institutional policies for elective procedures Physical Vital signs Weight and height An airway and sedation directed evaluation Risk stratification using the ASA Physical Status classification Informed consent Including benefits, risks, and alternatives to sedation 60 Steadman and Yun Table 5 Sample Consent (May be incorporated with procedural consent) For the procedure you are to undergo, sedation and analgesic medications are frequently required. The benefit of sedative and analgesic medication is to allow the safe, comfortable completion of your procedure. The primary risk of these medi- cations is respiratory depression (decreased breathing effort), which can be serious or even fatal if not treated. This risk is minimized by careful administration of these medications and by close monitoring of your blood pressure, heart rate, and breath- ing. You may be asked to take a deep breath periodically during the procedure and/ or administered oxygen. Infrequently, allergic reactions to medications can occur. If you are known to be allergic to any medications or have any concerns about receiving sedation/analgesia, please let us know so that we may address your con- cerns directly. You may decline the administration of sedatives and analgesics or wish to discuss other alternatives, which include general anesthesia, regional anes- thesia, or local anesthesia. If you elect to receive sedation and analgesia, by signing below, you consent to allow us to administer, as appropriate, the medication required for the comfortable completion of your procedure. Table 6 Recommendations for Frequency of Monitoring and Documentation During Sedation/Analgesia Conscious sedation Deep sedation Heart rate Continuous Continuous Oxygen saturation Continuous Continuous Respiratory rate Minimum of Minimum of every 15 min every 5 min Noninvasive blood pressure Minimum of Minimum of every 15 min every 5 min Level of consciousness Minimum of Minimum of every 5 min every 5 min Table 4 American Society of Anesthesiologist Physical Class Risk stratification Class I Normal, healthy patient Class II Mild systemic disease Class III Severe systemic disease Class IV Life-threatening illness Class V Moribund patient Practice Guidelines 61 methods of monitoring (19). In a study evaluating nursing interventions for hypoxemia, knowledge of the oxygen saturation influenced the timing of interventions and was believed to improve quality of care when compared to a second group of patients whose oxygen saturation values were revealed only if they fell below 85% (23). The accuracy and reliability of pulse oximeter values have also been evaluated. At low saturation values (below 80%), the pulse oximeter over- estimates the true value as measured by co-oximeter (24). Variations in accuracy between manufacturers occur below saturation values of 70% (25,26). This is probably most clinically relevant in patients with cyanotic heart disease, for whom co-oximetry should be used to verify the pulse oximeter. Situations producing low signal-to-noise ratios, such as patient motion, may produce artifactual pulse oximetry values. Recently introduced signal extraction technology reduces the incidence of erroneous and dropped readings (27,28). Despite these minor limitations, pulse oximetry is strongly advised in all sedation settings because of its considerable benefit, low cost, and negli- gible risk. However, pulse oximetry should not be viewed as a substitute for monitoring ventilatory function. 7.3. Respiratory Rate As drug-induced respiratory depression is the primary cause of morbid- ity associated with sedation/analgesia, ventilation monitoring by observa- tion or auscultation should be assessed on all patients (4). A decreasing respiratory rate may represent the earliest warning of medication over- dose, particularly during oxygen administration, when desaturation may be a late indicator of respiratory depression (4). In situations that require access to the patient, the evaluation of exhaled carbon dioxide can serve as an indicator of upper airway obstruction (29) or apnea. 7.4. Heart Rate and Blood Pressure Autonomic stimulation occurring during procedures may indicate inad- equate sedation/analgesia; conversely, sedation/analgesia may blunt appro- priate responses to procedural stress or hypovolemia. In a study of 100 patients undergoing endoscopy, 20 developed a tachycardia of over 120 beats per minute (bpm) (30). During colonoscopy, 16% of 223 patients had vasovagal reactions manifested by bradycardia to 60 bpm, hypotension, or diaphoresis (31). The only predictors of such a reaction were a higher mean dose of midazolam (4.6 mg vs 3.9 mg) and a higher rate of diverticulosis in those experiencing vasovagal reactions. About one-third of patients with vasova- 62 Steadman and Yun gal reactions required treatment. Electrocardiographic monitoring is not rou- tinely used in all ages, but is recommended in the elderly or in patients with known or suspected cardiovascular disease. Matot studied 29 patients over the age of 50 undergoing elective fiberoptic bronchoscopy and found that five patients (17%) had myocardial ischemia lasting 20 ± 8 min, associated with a mean increase in heart rate of 30 bpm (to 120 bpm) and a decrease in saturation from 95–90%, in the absence of blood pressure changes (32). He warned against the dangerous combination of hypoxemia and tachycardia, sug- gesting routine oxygen administration and avoidance of routine atropine usage. The routine monitoring of heart rate and blood pressure is recommended for all patients undergoing sedation/analgesia. 7.5. Temperature Although care should be taken to avoid hypo- or hyperthermia, there is no evidence that routine temperature monitoring improves outcome in adults. Temperature should be monitored in small infants or in children who are placed under warming lights. 7.6. Oxygen Administration Routine oxygen administration has repeatedly been shown to be beneficial during sedation/analgesia when used to avoid or delay the onset of hypox- emia. During endoscopy, oxygen administered at 2 L/min was as effective as 3 L/min and oral administration via a bite guard was as effective as nasal cannula-administered oxygen (33). In patients over the age of 60 undergo- ing endoscopic retrograde cholangiopancreatography (ERCP), the group randomized to receive nasal oxygen at 2 L/min required fewer interven- tions for hypoxemia and maintained significantly higher oxygen satura- tions throughout the procedure than the group that did not receive oxygen (34). The higher oxygen saturations did not protect patients who received oxygen from tachycardia, as both groups had short periods of significant tachycardia. Bowling found similar results during endoscopy in patients over 60 yr of age: oxygen saturation values improved with supplemental oxygen admin- istration, but the frequency of ventricular and supraventricular ectopic beats was not decreased (35). During colonoscopy in patients sedated with midazolam (2.6 ± 0.2 mg) and meperidine (48 ± 3 mg), those receiving oxy- gen at 3 L/min were less likely to desaturate to less than 90% than those breathing room air (10 of 28 vs 22 of 28) (36). The authors concluded that supplemental oxygen decreases the risk of, but does not prevent, hypoxemia. The period of risk for hypoxemia does not end with the completion of the proce- dure. Hardeman showed that 20 of 100 patients breathing room air became hypo- Practice Guidelines 63 xemic in the postanesthesia recovery room (vs 3 of 100 patients receiving supple- mental oxygen) after intravenous (iv) sedation for oral surgery (37). The clinical significance of the frequent finding of hypoxemia during sedation/analgesia is unclear. In fact, decreases in oxygen saturation to less than 90% occurred during sleep in 43% of asymptomatic men (13% had oxygen saturations <75%) (38). There are no studies showing that detection of a decrease of oxygen saturation alone, in the absence of other findings such as unresponsiveness, has an effect on patient outcome (39). However, because of the known risk of cardiopulmonary complications during seda- tion/analgesia and the fact that such complications represent more than 50% of the reported complications during gastrointestinal (GI) endoscopy (5), monitoring for—and the prevention of—hypoxemia should be routine. Because oxygen administration decreases the incidence and magnitude of hypoxemia, its routine administration should be strongly encouraged, par- ticularly in elderly patients or patients with co-existing disease. However, as its administration delays the recognition of respiratory depression by pulse oximetry, another means of evaluating ventilation—such as assessment of the quality and rate of respirations—should be routinely employed. 7.7. Drugs Knowledge of onset time, appropriate dosing frequency, the potential for side effects, and the appropriate agents to reverse respiratory depression are essential when administering sedation/analgesia. When inhalational agents such as nitrous oxide are used the maintenance of an adequate oxygen con- centration must be assured. (See Chapters 6 and 7 in this book for a detailed discussion of the drugs commonly used for sedation/analgesia.) Table 7 pro- vides suggestions regarding drug use during sedation/analgesia. Hospitals may define dosages of drugs that require the application of the sedation policy. For example, the JCAHO sample policy does not require adherence to sedation guidelines for adults who receive benzodiazepines in doses below a predetermined threshold, such as 5 mg of midazolam in patients under 60 yr of age. However, this sample policy applies to adults who receive any narcotic or combination of drugs and all pediatric (18-yr-old) patients (40). 7.8. Intravenous Access In adult patients receiving iv medications for sedation/analgesia, vascular access should be maintained throughout the procedure and until the patient is no longer at risk for sedation-related respiratory depression. In patients who have received sedation/analgesia by non-intravenous routes or whose iv line is no longer functional, the decision to establish or reestablish iv 64 Steadman and Yun access should be considered on a case-by-case basis. In all instances, an individual with the skills to establish iv access should be immediately avail- able (4). 8. DOCUMENTATION Documentation should include the patient’s diagnosis, planned procedure, the sedation/analgesia plan, the pre-, intra- and post-procedural assessment, the care provided, monitoring results, and discharge information. 9. RECOVERY AND DISCHARGE In the post-procedural period, the removal of stimulation exposes the patient to the unopposed effects of residual sedation. This is illustrated by a report of apnea occurring after reduction of a shoulder dislocation (41). When sedation/analgesia is administered to outpatients, the clinician should assume that they will not have immediate access to medical care or advice after discharge. Therefore, patients should have returned to their pre-procedural level of consciousness and no longer be at risk for respiratory depression, have stable vital signs, be adequately hydrated without active vomiting, have minimal discomfort, and be able to ambulate. If reversal of narcotics or ben- zodiazepines has been used, the observation period should be sufficient to assure that resedation does not occur. Patients should be given instructions for follow-up care and guidelines for when and how to seek emergency Table 7 Drug Principles for Sedation and Analgesia 1. Avoid making changes to a successful drug regimen. 2. When a drug regimen for adults must be changed, use the safest intravenous drug with the shortest duration of effect appropriate for the procedure. 3. Avoid suggesting drugs that require infusion pumps for safe administration. 4. Benzodiazepines alone rarely cause apnea. 5. Benzodiazepines produce anxiolysis and amnesia, not analgesia. 6. The shortest-acting benzodiazepines have durations of action considerably longer than the shortest-acting opioids. 7. Opioid-induced apnea frequently responds to tactile stimulation. 8. Opioids produce analgesia, not amnesia. They may produce apnea prior to sedation. 9. Benzodiazepines markedly potentiate opioid-induced respiratory depression. 10. Flumazenil antagonizes benzodiazepines; naloxone antagonizes opioids. 11. Ketamine and propofol are intravenous general anesthetics, and their use should be restricted to individuals with the expertise and privileges to use such agents. [...]... Surgeons Task Force on sedation and analgesia in ambulatory settings Plast Reconstr Surg 104:5, 155 9–1 564 7 American College of Emergency Physicians (1998) Clinical policy for procedural sedation and analgesia in the emergency department Ann Emerg Med 31 :5, 66 3 6 77 8 Innes, G., Murphy, M., Nijssen-Jordan, C., Ducharme, J., and Drummond, A (1999) Procedural sedation and analgesia in the emergency department... Clinical Neuroscience: Sedation and Analgesia for Diagnostic and Therapeutic Procedures Edited by: S Malviya, N N Naughton, and K K Tremper © Humana Press Inc., Totowa, NJ 77 78 Malviya Table 1 Goals of Sedation for Diagnostic and Therapeutic Procedures Analgesia Anxiolysis Amnesia Enhance patient comfort Facilitate cooperation/immobilization Promote patient safety 2 RADIOLOGIC PROCEDURES The use of... 51 3 5 17 39 American College of Emergency Physicians (1998) Clinical policy for procedural sedation and analgesia in the emergency department Ann Emerg Med 31 :5, 66 3 6 77 40 Joint Commission on Accreditation of Healthcare Organization (JCAHO) (1999) Accreditation Manual for Hospitals Oakbrook Terrace, IL, JCAHO, TX– 73 41 Wright, S., Chudnofsky, C., Dronen, S., et al (19 93) Comparison of midazolam and. .. perception of pain and decreases their ability to cooperate The goals of sedation for these procedures, therefore, include anxiolysis, analgesia, and amnesia, especially for children who require repeated procedures Adequate anxiolysis and analgesia facilitate the patient’s cooperation and ability to remain immobile, and greatly enhance their comfort during these procedures Administration of sedation in the... Anesthesiologists Task Force, Practice (1996) Guidelines for sedation and analgesia by non-anesthesiologists Anesthesiology 84(2), 45 9–4 71 5 American Society for Gastrointestinal Endoscopy (1995) Sedation and monitoring of patients undergoing gastrointestinal endoscopic procedures Gastrointest Endosc 42:6, 62 6–6 29 6 Iverson, R E (1999) Sedation and analgesia in ambulatory settings American Society of Plastic and Reconstructive... midazolam and diazepam for procedural sedation and analgesia in the emergency department Ann Emerg Med 22, 20 1–2 05 42 Manninen, P H., Chan, A S H., and Papworth, D (1997) Conscious sedation for interventional neuroradiology: a comparison of midazolam and propofol infusion Can J Anaesth 44:1, 2 6 3 0 43 Etzkorn, K P., Diab, F., Brown, R D., Dodda, G., Edelstein, B., Bedford, R., and Venu, R P (1998) Endoscopic... controlled trial Gastrointest Endosc 49:5, 55 4–5 59 73 Hoffman, M S., Butler, T W., and Shaver, T (1998) Colonoscopy without sedation J Clin Gastroenterol 26:4, 27 9–2 82 Pediatric Sedation 77 4 Procedure and Site-Specific Considerations for Pediatric Sedation Shobha Malviya, MD 1 INTRODUCTION The appropriate management of anxiety and pain for diagnostic and therapeutic procedures in children frequently requires... saturation monitoring during sedation for chemolysis Clin Radiol 44:5, 35 2 3 53 21 Murray, A W., Morran, C G., Kenny, G N., and Anderson, J R (1990) Arterial oxygen saturation during upper gastrointestinal endoscopy: the effects of a midazolam/pethidine combination Gut 31 :3, 27 0–2 73 22 McKee, C C., Ragland, J J., and Myers, J O (1991) An evaluation of multiple clinical variables for hypoxia during colonoscopy... R., Sugawa, C., and Wilson, R F (1989) Changes in oxygenation and pulse rate during endoscopy Am Surg 55 :3, 19 8–2 02 Practice Guidelines 73 31 Herman, L L., Kurtz, R C., McKee, K J., Sun, M., Thaler, H T., and Winawer, S J (19 93) Risk factors associated with vasovagal reactions during colonoscopy Gastrointest Endosc 39 :3, 38 8 3 91 32 Matot, I., Kramer, M R., Glantz, L., Drenger, B., and Cotev, S (1997)... Radiol 10, 24 7–2 53 2 Holzman, R S., Cullen, D J., Eichhorn, J H., and Philip, J H (1994) Guidelines for Sedation by nonanesthesiologists during diagnostic and therapeutic procedures J Clin Anesth 6, 26 5–2 76 3 Joint Commission on Accreditation of Healthcare Organization (JCAHO) 1999 (Jan.) Comprehensive Accreditation Manual for Hospitals: The Official Handbook Oakbrook Terrace, IL, JCAHO, TX–74 4 American . 31 :3, 27 0–2 73. 22. McKee, C. C., Ragland, J. J., and Myers, J. O. (1991) An evaluation of mul- tiple clinical variables for hypoxia during colonoscopy. Surg. Gynecol. Obstet. 1 73: 1, 3 7–4 0. 23. . Depth of Sedation Definition of General Anesthesia and Levels of Sedation/ Analgesia* Moderate Minimal sedation sedation /analgesia Deep General (Anxiolysis) (“sonscious sedation ) sedation/ analgesia. P., and Finlay, D. B. (1991) Technical report: oxy- gen saturation monitoring during sedation for chemolysis. Clin. Radiol. 44:5, 35 2 3 53. 21. Murray, A. W., Morran, C. G., Kenny, G. N., and Anderson,