Clinical Nurse SpecialistA Copyright B 2015 Wolters Kluwer Health | Lippincott Williams & Wilkins
Pharmacology Consult Column Editor: Patricia Anne O’Malley, PhD, RN, CNS
Finding a Way Through the Sedation Labyrinth Is It Conscious, Moderate, Deep, or Procedural Sedation? Emerging Evidence for CNS Practice Patricia Anne O’Malley, PhD, RN, CNS n Lindsey Poling, BSN, RN, SRNA
KEYWORDS anesthesia, CMS rules, conscious sedation, CRNA, nurse anesthesia, MAC, moderate sedation, pharmacology of sedation, procedural sedation
PHARMACOLOGY CONSULT I am a clinical nurse specialist (CNS) in a busy tertiary referral endoscopy center in the Midwest. In conversation, presentations, and even in the literature, sedation is identified as conscious, moderate, deep, or procedural. In practice, these sedation terms are often used interchangeably. However, in the literature, definitions of sedation appear to vary. Can you clear up this confusion? Please also address any emerging evidence regarding sedation. Sedation seems to be available in more and more practice settings, which I believe has safety implications for patients. Sedation is an evolving specialty worldwide. Fueled by consumer and practitioner demands for cardiovascular stability, airway preservation, and shorter recovery periods, sedation facilitates therapeutic and diagnostic procedures and is used to increase acceptance for regional anesthetic or blocks. Sedation provides analgesia, anxiolysis, and amnesia on a continuum that can range from anxiolysis to general anesthesia and promises comfort, safety, and convenience for the patient, anesthetist, and care provider.2 Finally, sedation reduces requirements for opioids and antiemetics.1 Author Affiliations: Nurse Researcher (Dr O’Malley), Center for Nursing Excellence, Miami Valley Hospital, Dayton, and Graduate Student (Ms Poling), the University of Akron College of NursingYAnesthesia Program, Ohio. The authors report no conflicts of interest. Correspondence: Patricia Anne O’Malley, PhD, RN, CNS, Miami Valley Hospital, 1 Wyoming St, Dayton, OH 45409 ([email protected]). DOI: 10.1097/NUR.0000000000000092
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Over the past decade, the search for the ‘‘ideal’’ sedative agent(s), dose, and delivery method continues. Desirable pharmacokinetic properties include rapid onset and clearance, easy titration, minimal adverse effects, and stable hemodynamic and respiratory profiles and amnesia, without extended time in the recovery room.1 While definitions for types of sedation vary, sedation is often described as a function of responses to verbal and painful stimuli, airway control, respiration, and cardiovascular activity.2 Recent definitions of levels of sedation and anesthesia are described in Table 1. Commonly used agents for sedation are described in Table 2. Over several decades, procedures under sedation outside the operating room environment have increased dramatically. With expansion of services into nonsurgery settings, the term procedural sedation (PS) is gradually covering minimal, moderate, and conscious sedation. Procedural sedation is used to describe the goals of sedation for any procedureV relief of pain and anxiety, keeping patients safe, and increasing the likelihood of a successful procedure. Because of the extensive monitoring required, the practitioner providing sedation should not be responsible for the procedure. Appropriate monitoring is crucial with rapid access to emergency equipment required wherever PS takes place whether the intensive care unit, emergency department, dental clinic, radiology, endoscopy, or office.8 Fluid policies, guidelines, and standards of care continue to emerge from state boards, accrediting organizations, federal agencies, and professional societies along with the restrictions and limits on reimbursement. For now, there is no one statement, guideline, or standard that defines PS for all settings in which PS takes place.8 Guidelines from the Centers for Medicare & Medicaid Services in 2010 and 2011 have had significant impact on January/February 2015
Copyright © 2014 Wolters Kluwer Health | Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
Table 1. Attributes of Sedation Levels and Anesthesia Minimal sedation: Also described as anxiolysis. The patient responds appropriately to verbal commands. Cognitive function and coordination may be impaired. Respiratory and cardiovascular functions are intact.2Y4 Moderate sedation/analgesia (conscious sedation): Deeper depression of consciousness. The patient responds purposefully to verbal command, either alone or when accompanied by light tactile stimulation. Patient is able to maintain a patent airway and respiration, and cardiovascular function is usually maintained.2Y4 Deep sedation/analgesia: The patient cannot be easily aroused, but responds purposefully following repeated or painful stimulation. Respiration may be impaired and may require assistance to maintain a patent airway. Cardiovascular function is usually maintained.2Y4 MAC: describes all aspects of anesthesia careVthe preprocedure, intraprocedure, and postprocedure care. Monitored anesthesia care can include varying levels of sedation, analgesia, and anxiolysis as necessary. During monitored anesthesia care, an anesthesiologist or certified registered nurse anesthetist provides specific services, including but not limited to, diagnosis and treatment of clinical problems that occur during the procedure, support of vital functions, administration of sedatives, analgesics, hypnotics, anesthetic agents, or other medications as necessary for patient safety and provides psychological support and physical comfort as needed to complete the procedure safely. The provider of monitored anesthesia care is assumed to be prepared and qualified to convert to general anesthesia when necessary. MAC becomes a general anesthesia event whether airway instrumentation is used when the patient loses consciousness and the ability to respond purposefully.5,6 General anesthesia: Patient cannot be aroused, even to painful stimuli. The ability to maintain respiration is significantly impaired, and airway assistance is often needed. Cardiovascular function may also be impaired.2Y4 Abbreviation: MAC, monitored anesthesia care.
the provision of PS in the United States with the defining deep sedation as part of Monitored Anesthesia Care. In the case of certified registered nurse anesthetists (CRNAs), Table 2. Common Medications for Sedation
unless the CRNA is practicing in an opt-out state under x482.52(c) (http://www.canainc.org/compendium/pdfs/C% 202%20CoP%20Hospital&guidelines.pdf), the CRNA must
2,7
Class
Intravenous Agent
Effects
Outcomes
Issues
Benzodiazepine
Midazolam (Versed)
Potentiate GABA inhibitory action in central nervous system
Sedation, amnesia, anxiolysis, anticonvulsant
Half-life time increased significantly in obese patients
Benzodiazepine
Lorazepam (Ativan)
Preferred for longer term sedationVin intensive care unit setting
Sedation, amnesia, anxiolysis
Longer duration compared with midazolam
Opiate
Fentanyl
Analgesia and sedation
Preferred to morphine; rapid onset, short duration of action, minimal cardiorespiratory depression
Increases pain threshold; ideal opioid for procedural sedation
Sedative dissociative agent
Ketamine (Ketalar)
Inhibit the action of, the NMDA receptor
Dissociative anesthesia; amnesia and analgesia without respiratory suppression; use with caution in ischemic heart disease
Risk of emergence delirium in up to 20% of patients; concomitant use of propofol reduces risk
Hypnotic/amnestic
Propofol (Diprivan)
Rapid-onset sedation similar to general anesthesiaVthought to mediate +-aminobutyric acid and NMDA activity
Use with caution in hemodynamically unstable or in patients reliant on sympathetic tone
No analgesic properties; monitor for hypotension with bolus
Nonbarbiturate hypnotic
Etomidate (Amidate)
Ideal induction agent for hemodynamically unstable patients
Rapid induction without histamine release or cardiorespiratory risk
High risks of nausea/ vomiting with bolus; and adrenal suppression; add analgesia for painful procedures
Agonist of !2-adrenergic receptors
Dexmedetomidine (Precedex)
Sedation, analgesia, anxiolysis without respiratory depression, for short-term procedures
Low index of adverse effects, more predictive outcomes; use will probably increase in the future
Use of additional analgesics necessary for painful procedures
Abreviations: GABA, gamma-aminobutyric acid; NMDA, N-methyl-D-aspartate.
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Pharmacology Consult be supervised when administering anesthesia. Local anesthetics and minimal and moderate sedation are not treated as anesthesia and therefore are not subject to the CRNA supervision requirements. A current list of the states that have exercised their opt-out option and that are exempted from the requirements for physician supervision of CRNAs under x482.52(a) is available at http://www.cms.hhs.gov/ CFCsAndCoPs/02_Spotlight.asp. In some states, these guidelines have increased staffing requirements as well as financial burdens on current anesthesia resources already spread thin over multiple settings.8 As the demand for procedural and deep sedation intensifies, so have the number of guidelines issued by professional organizations and societies. Guidelines address training, credentialing, and maintenance of competency in PS independent of state or organizational requirements. Although there appears to be consensus in the content of these guidelines and statements, the reality is there is more rather than less debate, particularly around credentialing, privileging, and practice. The politics underlying these debates will continue until better evidence emerges from large outcome trials instead of small retrospective studies with little external validity. Table 3 describes organizations with guidelines for PS as well as Web sites to obtain information. Resources, mandates, procedures, guidelines, and best practices can be found readily on these Web sites. With the expansion of an anesthesia specialty in medicine, the debate has intensified between medicine and nursing. Often lost in the conversation is the memory of nursing’s long history of anesthesia administration. In some low- and middle-income rural countries, there is an average of 1 physician anesthetist per 100000 of the population. The benefit of independent nursing practice in areas that attract fewer physician providers could significantly improve healthcare for persons living in these areas. With increasing demand for surgery, pressure on healthcare providers to reduce costs, and the predicted shortfall in the number of anesthesia providers, it is important to consider existing literature; there is no evidence to support
one discipline over another in the provision of safe PS.9 The literature is full of retrospective evaluation of patient outcomes by multiple sedation providers in the surgery suite, emergency room, and interventional areas. These small studies demonstrate nonsignificant differences in outcomes and adverse events across settings for medicine and nonmedicine providers. While all report excellent safety profiles, legal claims regarding adverse outcomes with PS including death and permanent brain damage may be trending upward for some patient groups and settings.8 Limited data regarding sedation complication rates with inconsistent language and definitions make evaluation of current findings in the literature problematic. Whereas overall mortality appears low, morbidity may be problematic. Table 4 provides a review of 20 articles selected from an in-depth review of the literature for PS for 2010 to 2013. We believe that these selected articles provide meaningful evidence regarding PS that may be helpful for the CNS in a variety of settings. Eighteen articles describe PS outcomes from retrospective and prospective analysis in multiple settings and adult populations. Article 11 of Table 4 provides information to assist in organizing and reporting adverse events associated with sedation. Article 20 provides significant evidence for the CNS in pediatrics. From this in-depth review, emerging trends can be further identified. These practices include capnography monitoring for earlier detection of respiratory compromise, patient-controlled sedation, target-controlled infusion, and computer-assisted personalized sedation, which can provide automated propofol delivery based on integrated hemodynamic and ventilatory parameters.3 In summary, larger trials are required with targeted focus on outcomes associated with training and credentialing. Common language and definitions will help all disciplines monitor, communicate, and evaluate PS practices and outcomes. Particularly important for future education and research is the establishment of standardized outcomes across all disciplines for all patients.8,9
Table 3. Specialty Organizations Guidelines for Procedural Sedation No.
2
Organization
Web Address
1
American Association of Nurse Anesthetists
http://www.aana.com/Search/Pages/DefaultResults.aspx?k=conscious%20sedation
2
The Joint Commission on Accreditation of Healthcare Organizations
http://www.jointcommission.org/standards_information/jcfaqdetails.aspx?Standards FaqId=457&ProgramId=47
3
American Society of Anesthesiologists
https://www.asahq.org/coveo.aspx?q=conscious%20sedation
4
American College of Emergency Physicians
http://www.acep.org/search.aspx?searchtext=conscious%20sedation
5
The Society of Gastroenterology Nurses and Associates
To access practice guidelines and position statements for endoscopic sedation by the American College of Gastroenterology, the American Gastroenterological Association Institute, the American Society for Gastrointestinal Endoscopy, and Society of Gastroenterology Nurses and Associates http://www.sgna.org/Issues/SedationFactsorg/StandardsRegulations/ guidelines.aspx
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Patients receiving spinal anesthesia
Outpatient colonoscopy
Regional burn center
Two apnea and hypopnea assessment tools (STOP-Bang and OSA) to predict respiratory risk with sedation had some value. Only 34 patients were studied. For low-risk patients, endoscopistcontrolled propofol sedation is safe. Patients at least age 65 y and/or ASA II classified are more likely to have a decrease in blood pressure and longer recovery period. Ten adverse events, all respiratory related, documented in 8 patients, for an adverse event rate of 0.77%. For 328 patients, none required intubation. Procedural sedation administered by an RN competent in administration and monitoring in a burn center provided safe and effective pain management during wound care.
Effectiveness of LACS compared with GA for TAVI.
Safety and effectiveness of sedation with propofol for colonoscopy. Clinical predictors for apneahypopnea during propofol sedation.
Safety and efficacy outcomes of propofol administration by nonanesthesiologist (nurse) for colonoscopy in American Society of Anesthesiologists I and II class patients. Safety and efficacy of RN administration of procedural sedation/analgesia during wound care.
World J Gastroenterol. 2012;18(26):3420Y3425.
Anaesthesia. 2012;67(7): 755Y759.
Eur J Gastroenterol Hepatol. 2012;24(7): 787Y792.
J Burn Care Res. 2012;33(4):504Y509.
4. Safety and effectiveness of propofol sedation during and after outpatient colonoscopy. Horiuchi A, Nakayama Y, Kajiyama M, et al.
5. Clinical predictors of apnoea-hypopnoea during propofol sedation in patients undergoing spinal anaesthesia. Kim GH, Lee JJ, Choi SJ, et al.
6. Nonanesthesiologist-administered propofol sedation for colonoscopy is safe and effective: a prospective Spanish study over 1000 consecutive exams. Lucendo AJ, Olveira A, Friginal-Ruiz AB, et al.
7. Efficacy and safety of procedural sedation and analgesia for burn wound care. Thompson EM, Andrews DD, Christ-Libertin C.
Outpatient colonoscopy
Prospective evaluation of 2101 patients using age-adjusted dosing protocol. Dose up to 200mg safe for outpatient colonoscopy.
(continues)
Cardiac laboratory
TAVI with LACS can be successfully performed. Must balance the advantage of earlier recovery with perioperative risks.
Community hospital outpatient procedures
Am J Cardiol. 2013;111(1):94Y99.
No statistical differences between presedation and postsedation oxygenation measures for patients undergoing moderate sedation: 92 left against medical advice before completion of the recovery period without complications.
3. Effect of local anesthetic management with conscious sedation in patients undergoing transcatheter aortic valve implantation. Yamamoto M, Meguro K, Mouillet G, et al.
1. Psychological impact of unexpected explicit recall of events occurring during surgery performed under sedation, regional anaesthesia, and general anaesthesia: data from the Anesthesia Awareness Registry. Kent CD, Mashour GA, Metzger NA, et al. Outcomes evaluation of a 3-h recovery period for patients with OSA for 118 subjects in a 369-bed community hospital.
Inpatient and outpatient surgery
Practice Area(s)
Gastroenterol Nurs. 2013;36(4):260Y264.
Analysis of data from Anesthesia Awareness Registry; 40% of patients reporting awareness under sedation or RA had persistent sequelae similar to GA patients, and 15% reported a diagnosis of posttraumatic stress disorder.
Findings/Recommendations
2. How long is too long? Recovery time of outpatients with sleep apnea after procedural sedation. Neville A, Coe K, Thompson J.
Study Summary Comparison of outcomes of awareness during GA, RA, and sedation. Unknown if explicit recall during sedation or RA results in psychological trauma similar to awareness during GA.
Journal
Br J Anaesth. 2013;110(3):381Y387.
Title/Author
Table 4. Review of Selected Literature 2010Y2013
16 Antihypertensive therapy continuation before colonoscopy with conscious sedation.
Comparison of TCI with PCS. Outcomes included propofol use, procedure ease, and recovery. Is proceduralist-directed, nurse-administered propofol sedation safe?
Presentation of a proposed standardized tool to report and benchmark adverse events related to conscious sedation.
Identify factors associated with complications of PSA administered by physicians in an emergency room over a 2-y period. Relationship of BMI and complications during advanced endoscopic procedures using propofol (1016 patients).
Endoscopy. 2013;45(11): 915Y919.
Heart Rhythm. 2012;9(3): 342Y346.
Br J Anaesth. 2012;108(1): 13Y20.
Emerg Med J. 2011;28(12): 1036Y1040.
Gastrointest Endosc. 2011;74 (6):1238Y1247.
9. A randomized comparison of target-controlled propofol infusion and patient-controlled sedation during ERCP. Mazanikov M, Udd M, Kyl.np.. L, et al.
10. A retrospective analysis of proceduralist-directed, nurse-administered propofol sedation for implantable cardioverter-defibrillator procedures. Sayfo S, Vakil KP, Alqaqa’a A, et al.
11. Adverse event reporting tool to standardize the reporting and tracking of adverse events during procedural sedation: a consensus document from The World SIVA International Sedation Task Force. Mason KP, Green SM, Piacevoli Q; International Sedation Task Force.
12. Procedural sedation and analgesia in a large UK Emergency Department: factors associated with complications. Jacques KG, Dewar A, Gray A, et al.
13. Obesity as a risk factor for sedation-related complications during Propofol-mediated sedation for advanced endoscopic procedures. Wani S, Azar R, Hovis CE, et al.
Study Summary
J Gastrointestin Liver Dis. 2012; 21(2):165Y170.
Journal
8. Anti-hypertensive therapy and risk factors associated with hypotension during colonoscopy under conscious sedation. Tang DM, Simmons K, Friedenberg FK.
Title/Author
Table 4. Review of Selected Literature 2010–2013, Continued
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Procedure: ERCP
Tertiary referral centerVICD-related procedures
Evidence-based practiceVdefining sedation outcomes
Emergency room PSA by physicians
Single tertiary-care referral centerVendoscopic procedures
No benefit of TCI over PCS for this sample. Consider PCS dosing for endoscopic retrograde cholangiopancreatography related to ease of use, less propofol consumption, and faster recovery. Nurse-administered sedation for shorter ICD procedures such as single- and dual-chamber implants, generator changes, and defibrillation threshold testing had acceptable adverse event numbers. However, biventricular implants and other complex procedures should have an anesthesiologist. Longer procedures and biventricular implant were independent predictors of adverse events. International Sedation Task Force consensus document to solve the problem in sedation outcomes evaluation: no established definitions or language for sedation-related adverse events for reporting and benchmarking.
For 1402 patients, complications occurred in 3.5% of cases (n = 49). Deeper levels of sedation and procedures occurring at night were identified as risk factors for complications. Increasing BMI associated with increased airway maneuvers and hypoxemia (P G.001).
(continues)
Outpatient colonoscopy
Practice Area(s)
In a sample of 628 patients, for 158 patients taking antihypertensive therapy (regardless of class) within 24h of the procedure was not associated with increased risk for procedural hypotension.
Findings/Recommendations
Pharmacology Consult
January/February 2015
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17
Outcomes for NAPS during routine endoscopic procedures in 215 patients with OSA.
Prospective evaluation of EDPS outcomes administered by physicians.
Compared the frequency of respiratory depression during EDPS with KP versus P. Also evaluated provider satisfaction, sedation quality, and total dose. All subjects were pretreated with intravenous fentanyl. Outcomes evaluation of 496 procedures for 340 patients with 358 unruptured aneurysms.
Comparison of PCS vs EPCS in the emergency department.
Review of published evidence to assess the safest most effective methods for procedural sedation in children having GIE. Search found 182 references; final review includes 11 RCTs and 15 non-RCTs.
Dig Dis Sci. 2011;56(9): 2666Y2671.
Am J Emerg Med. 2011;29 (5):541Y544.
Ann Emerg Med. 2011;57(5): 435Y441.
J Neurosurg. 2011;114(1):120Y128.
Ann Emerg Med. 2010;56(5): 502Y508.
J Pediatr Gastroenterol Nutr. 2012;54(2):171Y185.
15. Nurse-administered propofol sedation is safe for patients with obstructive sleep apnea undergoing routine endoscopy: a pilot study. Adler DG, Kawa C, Hilden K, Fang J.
16. ED procedural sedation of elderly patients: is it safe? Weaver CS, Terrell KM, Bassett R, et al.
17. A randomized controlled trial of ketamine/propofol versus propofol alone for emergency department procedural sedation. David H, Shipp J.
18. Neurointerventional procedures for unruptured intracranial aneurysms under procedural sedation and local anesthesia: a large-volume, single center experience. Ogilvy CS, Yang X, Jamil OA, et al.
19. A randomized controlled trial comparing patient-controlled and physician-controlled sedation in the emergency department. Bell A, Lipp T, Greenslade J, et al.
20. Safe and effective procedural sedation for gastrointestinal endoscopy in children. van Beek EJ, Leroy PL.
Emergency room
Hospital neurointervention
Incidence of respiratory depression was similarVKP was 22%, and P was 28%. Patients who received KP received less propofol with a trend toward improved sedation quality. Conscious sedation (local anesthesia) appears to be effective for most patients with unruptured intracranial aneurysms; also associated with shorter length of stay.
Literature review for pediatric best practices
Emergency room
For 864 observations, there were no significant differences in adverse events or complications by age. Only significant differenceVtotal sedative dose was lower for patients 965 y old.
Lack of RCTs that address effectiveness and safety. Limited evidence suggests that propofol based sedation may be best practice for children having GIE; however, evidence base is limited.
Hospital endoscopy
Procedures were accomplished more quickly with NAPS. No significant differences in complications or outcomes for OSA compared with non-OSA patients.
Emergency department
Ambulatory interventional spinal surgery center
Adverse events for conscious sedation 5.12% and for the local anesthesia 4.82% (no statistical difference). Patients in the local anesthesia group had higher rates of hypertension. No serious adverse events.
PCS safety, recovery, and satisfaction were similar to EPCS with a nonsignificant trend to lower total propofol dose. Adverse events and recovery time were not significantly different.
Practice Area(s)
Findings/Recommendations
Abbreviations: ASA, American Society of Anesthesiologists; BMI, body mass index; EDPS, emergency department procedural sedation; EPCS, emergency physician-controlled sedation; ERCP, endoscopic retrograde cholangiopancreatography; GA, general anesthesia; GIE, gastrointestinal endoscopy; ICD, implantable cardioverter-defibrillator; KP, ketamine and propofol; LACS, local anesthesia with conscious sedation; NAPS, nurse-administered propofol sedation; OSA, obstructive sleep apnea; PCS, patient-controlled sedation; P, propofol; PSA, procedural sedation and analgesia; RA, regional anesthesia; RCT, randomized controlled clinical trial; RN, registered nurse; STOP-Bang, Snoring? Tired? Observed? Pressure? Body mass index morethan 35 kg/m2? Age older than 50? Neck size large? Gender = male?; TAVI, transcatheter aortic valve implantation; TCI, target-controlled infusion.
Rate of adverse events using conscious sedation; 2494 cases reviewed; 1228 spine procedures used local and conscious sedation, 1266 had local anesthesia alone.
Study Summary
Spine J. 2011;11(12): 1093Y1100.
Journal
14. Adverse events of conscious sedation in ambulatory spine procedures. Schaufele MK, Mar
Pharmacology Consult Column Editor: Patricia Anne O’Malley, PhD, RN, CNS
Finding a Way Through the Sedation Labyrinth Is It Conscious, Moderate, Deep, or Procedural Sedation? Emerging Evidence for CNS Practice Patricia Anne O’Malley, PhD, RN, CNS n Lindsey Poling, BSN, RN, SRNA
KEYWORDS anesthesia, CMS rules, conscious sedation, CRNA, nurse anesthesia, MAC, moderate sedation, pharmacology of sedation, procedural sedation
PHARMACOLOGY CONSULT I am a clinical nurse specialist (CNS) in a busy tertiary referral endoscopy center in the Midwest. In conversation, presentations, and even in the literature, sedation is identified as conscious, moderate, deep, or procedural. In practice, these sedation terms are often used interchangeably. However, in the literature, definitions of sedation appear to vary. Can you clear up this confusion? Please also address any emerging evidence regarding sedation. Sedation seems to be available in more and more practice settings, which I believe has safety implications for patients. Sedation is an evolving specialty worldwide. Fueled by consumer and practitioner demands for cardiovascular stability, airway preservation, and shorter recovery periods, sedation facilitates therapeutic and diagnostic procedures and is used to increase acceptance for regional anesthetic or blocks. Sedation provides analgesia, anxiolysis, and amnesia on a continuum that can range from anxiolysis to general anesthesia and promises comfort, safety, and convenience for the patient, anesthetist, and care provider.2 Finally, sedation reduces requirements for opioids and antiemetics.1 Author Affiliations: Nurse Researcher (Dr O’Malley), Center for Nursing Excellence, Miami Valley Hospital, Dayton, and Graduate Student (Ms Poling), the University of Akron College of NursingYAnesthesia Program, Ohio. The authors report no conflicts of interest. Correspondence: Patricia Anne O’Malley, PhD, RN, CNS, Miami Valley Hospital, 1 Wyoming St, Dayton, OH 45409 ([email protected]). DOI: 10.1097/NUR.0000000000000092
12
www.cns-journal.com
Over the past decade, the search for the ‘‘ideal’’ sedative agent(s), dose, and delivery method continues. Desirable pharmacokinetic properties include rapid onset and clearance, easy titration, minimal adverse effects, and stable hemodynamic and respiratory profiles and amnesia, without extended time in the recovery room.1 While definitions for types of sedation vary, sedation is often described as a function of responses to verbal and painful stimuli, airway control, respiration, and cardiovascular activity.2 Recent definitions of levels of sedation and anesthesia are described in Table 1. Commonly used agents for sedation are described in Table 2. Over several decades, procedures under sedation outside the operating room environment have increased dramatically. With expansion of services into nonsurgery settings, the term procedural sedation (PS) is gradually covering minimal, moderate, and conscious sedation. Procedural sedation is used to describe the goals of sedation for any procedureV relief of pain and anxiety, keeping patients safe, and increasing the likelihood of a successful procedure. Because of the extensive monitoring required, the practitioner providing sedation should not be responsible for the procedure. Appropriate monitoring is crucial with rapid access to emergency equipment required wherever PS takes place whether the intensive care unit, emergency department, dental clinic, radiology, endoscopy, or office.8 Fluid policies, guidelines, and standards of care continue to emerge from state boards, accrediting organizations, federal agencies, and professional societies along with the restrictions and limits on reimbursement. For now, there is no one statement, guideline, or standard that defines PS for all settings in which PS takes place.8 Guidelines from the Centers for Medicare & Medicaid Services in 2010 and 2011 have had significant impact on January/February 2015
Copyright © 2014 Wolters Kluwer Health | Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
Table 1. Attributes of Sedation Levels and Anesthesia Minimal sedation: Also described as anxiolysis. The patient responds appropriately to verbal commands. Cognitive function and coordination may be impaired. Respiratory and cardiovascular functions are intact.2Y4 Moderate sedation/analgesia (conscious sedation): Deeper depression of consciousness. The patient responds purposefully to verbal command, either alone or when accompanied by light tactile stimulation. Patient is able to maintain a patent airway and respiration, and cardiovascular function is usually maintained.2Y4 Deep sedation/analgesia: The patient cannot be easily aroused, but responds purposefully following repeated or painful stimulation. Respiration may be impaired and may require assistance to maintain a patent airway. Cardiovascular function is usually maintained.2Y4 MAC: describes all aspects of anesthesia careVthe preprocedure, intraprocedure, and postprocedure care. Monitored anesthesia care can include varying levels of sedation, analgesia, and anxiolysis as necessary. During monitored anesthesia care, an anesthesiologist or certified registered nurse anesthetist provides specific services, including but not limited to, diagnosis and treatment of clinical problems that occur during the procedure, support of vital functions, administration of sedatives, analgesics, hypnotics, anesthetic agents, or other medications as necessary for patient safety and provides psychological support and physical comfort as needed to complete the procedure safely. The provider of monitored anesthesia care is assumed to be prepared and qualified to convert to general anesthesia when necessary. MAC becomes a general anesthesia event whether airway instrumentation is used when the patient loses consciousness and the ability to respond purposefully.5,6 General anesthesia: Patient cannot be aroused, even to painful stimuli. The ability to maintain respiration is significantly impaired, and airway assistance is often needed. Cardiovascular function may also be impaired.2Y4 Abbreviation: MAC, monitored anesthesia care.
the provision of PS in the United States with the defining deep sedation as part of Monitored Anesthesia Care. In the case of certified registered nurse anesthetists (CRNAs), Table 2. Common Medications for Sedation
unless the CRNA is practicing in an opt-out state under x482.52(c) (http://www.canainc.org/compendium/pdfs/C% 202%20CoP%20Hospital&guidelines.pdf), the CRNA must
2,7
Class
Intravenous Agent
Effects
Outcomes
Issues
Benzodiazepine
Midazolam (Versed)
Potentiate GABA inhibitory action in central nervous system
Sedation, amnesia, anxiolysis, anticonvulsant
Half-life time increased significantly in obese patients
Benzodiazepine
Lorazepam (Ativan)
Preferred for longer term sedationVin intensive care unit setting
Sedation, amnesia, anxiolysis
Longer duration compared with midazolam
Opiate
Fentanyl
Analgesia and sedation
Preferred to morphine; rapid onset, short duration of action, minimal cardiorespiratory depression
Increases pain threshold; ideal opioid for procedural sedation
Sedative dissociative agent
Ketamine (Ketalar)
Inhibit the action of, the NMDA receptor
Dissociative anesthesia; amnesia and analgesia without respiratory suppression; use with caution in ischemic heart disease
Risk of emergence delirium in up to 20% of patients; concomitant use of propofol reduces risk
Hypnotic/amnestic
Propofol (Diprivan)
Rapid-onset sedation similar to general anesthesiaVthought to mediate +-aminobutyric acid and NMDA activity
Use with caution in hemodynamically unstable or in patients reliant on sympathetic tone
No analgesic properties; monitor for hypotension with bolus
Nonbarbiturate hypnotic
Etomidate (Amidate)
Ideal induction agent for hemodynamically unstable patients
Rapid induction without histamine release or cardiorespiratory risk
High risks of nausea/ vomiting with bolus; and adrenal suppression; add analgesia for painful procedures
Agonist of !2-adrenergic receptors
Dexmedetomidine (Precedex)
Sedation, analgesia, anxiolysis without respiratory depression, for short-term procedures
Low index of adverse effects, more predictive outcomes; use will probably increase in the future
Use of additional analgesics necessary for painful procedures
Abreviations: GABA, gamma-aminobutyric acid; NMDA, N-methyl-D-aspartate.
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A
www.cns-journal.com
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Pharmacology Consult be supervised when administering anesthesia. Local anesthetics and minimal and moderate sedation are not treated as anesthesia and therefore are not subject to the CRNA supervision requirements. A current list of the states that have exercised their opt-out option and that are exempted from the requirements for physician supervision of CRNAs under x482.52(a) is available at http://www.cms.hhs.gov/ CFCsAndCoPs/02_Spotlight.asp. In some states, these guidelines have increased staffing requirements as well as financial burdens on current anesthesia resources already spread thin over multiple settings.8 As the demand for procedural and deep sedation intensifies, so have the number of guidelines issued by professional organizations and societies. Guidelines address training, credentialing, and maintenance of competency in PS independent of state or organizational requirements. Although there appears to be consensus in the content of these guidelines and statements, the reality is there is more rather than less debate, particularly around credentialing, privileging, and practice. The politics underlying these debates will continue until better evidence emerges from large outcome trials instead of small retrospective studies with little external validity. Table 3 describes organizations with guidelines for PS as well as Web sites to obtain information. Resources, mandates, procedures, guidelines, and best practices can be found readily on these Web sites. With the expansion of an anesthesia specialty in medicine, the debate has intensified between medicine and nursing. Often lost in the conversation is the memory of nursing’s long history of anesthesia administration. In some low- and middle-income rural countries, there is an average of 1 physician anesthetist per 100000 of the population. The benefit of independent nursing practice in areas that attract fewer physician providers could significantly improve healthcare for persons living in these areas. With increasing demand for surgery, pressure on healthcare providers to reduce costs, and the predicted shortfall in the number of anesthesia providers, it is important to consider existing literature; there is no evidence to support
one discipline over another in the provision of safe PS.9 The literature is full of retrospective evaluation of patient outcomes by multiple sedation providers in the surgery suite, emergency room, and interventional areas. These small studies demonstrate nonsignificant differences in outcomes and adverse events across settings for medicine and nonmedicine providers. While all report excellent safety profiles, legal claims regarding adverse outcomes with PS including death and permanent brain damage may be trending upward for some patient groups and settings.8 Limited data regarding sedation complication rates with inconsistent language and definitions make evaluation of current findings in the literature problematic. Whereas overall mortality appears low, morbidity may be problematic. Table 4 provides a review of 20 articles selected from an in-depth review of the literature for PS for 2010 to 2013. We believe that these selected articles provide meaningful evidence regarding PS that may be helpful for the CNS in a variety of settings. Eighteen articles describe PS outcomes from retrospective and prospective analysis in multiple settings and adult populations. Article 11 of Table 4 provides information to assist in organizing and reporting adverse events associated with sedation. Article 20 provides significant evidence for the CNS in pediatrics. From this in-depth review, emerging trends can be further identified. These practices include capnography monitoring for earlier detection of respiratory compromise, patient-controlled sedation, target-controlled infusion, and computer-assisted personalized sedation, which can provide automated propofol delivery based on integrated hemodynamic and ventilatory parameters.3 In summary, larger trials are required with targeted focus on outcomes associated with training and credentialing. Common language and definitions will help all disciplines monitor, communicate, and evaluate PS practices and outcomes. Particularly important for future education and research is the establishment of standardized outcomes across all disciplines for all patients.8,9
Table 3. Specialty Organizations Guidelines for Procedural Sedation No.
2
Organization
Web Address
1
American Association of Nurse Anesthetists
http://www.aana.com/Search/Pages/DefaultResults.aspx?k=conscious%20sedation
2
The Joint Commission on Accreditation of Healthcare Organizations
http://www.jointcommission.org/standards_information/jcfaqdetails.aspx?Standards FaqId=457&ProgramId=47
3
American Society of Anesthesiologists
https://www.asahq.org/coveo.aspx?q=conscious%20sedation
4
American College of Emergency Physicians
http://www.acep.org/search.aspx?searchtext=conscious%20sedation
5
The Society of Gastroenterology Nurses and Associates
To access practice guidelines and position statements for endoscopic sedation by the American College of Gastroenterology, the American Gastroenterological Association Institute, the American Society for Gastrointestinal Endoscopy, and Society of Gastroenterology Nurses and Associates http://www.sgna.org/Issues/SedationFactsorg/StandardsRegulations/ guidelines.aspx
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Patients receiving spinal anesthesia
Outpatient colonoscopy
Regional burn center
Two apnea and hypopnea assessment tools (STOP-Bang and OSA) to predict respiratory risk with sedation had some value. Only 34 patients were studied. For low-risk patients, endoscopistcontrolled propofol sedation is safe. Patients at least age 65 y and/or ASA II classified are more likely to have a decrease in blood pressure and longer recovery period. Ten adverse events, all respiratory related, documented in 8 patients, for an adverse event rate of 0.77%. For 328 patients, none required intubation. Procedural sedation administered by an RN competent in administration and monitoring in a burn center provided safe and effective pain management during wound care.
Effectiveness of LACS compared with GA for TAVI.
Safety and effectiveness of sedation with propofol for colonoscopy. Clinical predictors for apneahypopnea during propofol sedation.
Safety and efficacy outcomes of propofol administration by nonanesthesiologist (nurse) for colonoscopy in American Society of Anesthesiologists I and II class patients. Safety and efficacy of RN administration of procedural sedation/analgesia during wound care.
World J Gastroenterol. 2012;18(26):3420Y3425.
Anaesthesia. 2012;67(7): 755Y759.
Eur J Gastroenterol Hepatol. 2012;24(7): 787Y792.
J Burn Care Res. 2012;33(4):504Y509.
4. Safety and effectiveness of propofol sedation during and after outpatient colonoscopy. Horiuchi A, Nakayama Y, Kajiyama M, et al.
5. Clinical predictors of apnoea-hypopnoea during propofol sedation in patients undergoing spinal anaesthesia. Kim GH, Lee JJ, Choi SJ, et al.
6. Nonanesthesiologist-administered propofol sedation for colonoscopy is safe and effective: a prospective Spanish study over 1000 consecutive exams. Lucendo AJ, Olveira A, Friginal-Ruiz AB, et al.
7. Efficacy and safety of procedural sedation and analgesia for burn wound care. Thompson EM, Andrews DD, Christ-Libertin C.
Outpatient colonoscopy
Prospective evaluation of 2101 patients using age-adjusted dosing protocol. Dose up to 200mg safe for outpatient colonoscopy.
(continues)
Cardiac laboratory
TAVI with LACS can be successfully performed. Must balance the advantage of earlier recovery with perioperative risks.
Community hospital outpatient procedures
Am J Cardiol. 2013;111(1):94Y99.
No statistical differences between presedation and postsedation oxygenation measures for patients undergoing moderate sedation: 92 left against medical advice before completion of the recovery period without complications.
3. Effect of local anesthetic management with conscious sedation in patients undergoing transcatheter aortic valve implantation. Yamamoto M, Meguro K, Mouillet G, et al.
1. Psychological impact of unexpected explicit recall of events occurring during surgery performed under sedation, regional anaesthesia, and general anaesthesia: data from the Anesthesia Awareness Registry. Kent CD, Mashour GA, Metzger NA, et al. Outcomes evaluation of a 3-h recovery period for patients with OSA for 118 subjects in a 369-bed community hospital.
Inpatient and outpatient surgery
Practice Area(s)
Gastroenterol Nurs. 2013;36(4):260Y264.
Analysis of data from Anesthesia Awareness Registry; 40% of patients reporting awareness under sedation or RA had persistent sequelae similar to GA patients, and 15% reported a diagnosis of posttraumatic stress disorder.
Findings/Recommendations
2. How long is too long? Recovery time of outpatients with sleep apnea after procedural sedation. Neville A, Coe K, Thompson J.
Study Summary Comparison of outcomes of awareness during GA, RA, and sedation. Unknown if explicit recall during sedation or RA results in psychological trauma similar to awareness during GA.
Journal
Br J Anaesth. 2013;110(3):381Y387.
Title/Author
Table 4. Review of Selected Literature 2010Y2013
16 Antihypertensive therapy continuation before colonoscopy with conscious sedation.
Comparison of TCI with PCS. Outcomes included propofol use, procedure ease, and recovery. Is proceduralist-directed, nurse-administered propofol sedation safe?
Presentation of a proposed standardized tool to report and benchmark adverse events related to conscious sedation.
Identify factors associated with complications of PSA administered by physicians in an emergency room over a 2-y period. Relationship of BMI and complications during advanced endoscopic procedures using propofol (1016 patients).
Endoscopy. 2013;45(11): 915Y919.
Heart Rhythm. 2012;9(3): 342Y346.
Br J Anaesth. 2012;108(1): 13Y20.
Emerg Med J. 2011;28(12): 1036Y1040.
Gastrointest Endosc. 2011;74 (6):1238Y1247.
9. A randomized comparison of target-controlled propofol infusion and patient-controlled sedation during ERCP. Mazanikov M, Udd M, Kyl.np.. L, et al.
10. A retrospective analysis of proceduralist-directed, nurse-administered propofol sedation for implantable cardioverter-defibrillator procedures. Sayfo S, Vakil KP, Alqaqa’a A, et al.
11. Adverse event reporting tool to standardize the reporting and tracking of adverse events during procedural sedation: a consensus document from The World SIVA International Sedation Task Force. Mason KP, Green SM, Piacevoli Q; International Sedation Task Force.
12. Procedural sedation and analgesia in a large UK Emergency Department: factors associated with complications. Jacques KG, Dewar A, Gray A, et al.
13. Obesity as a risk factor for sedation-related complications during Propofol-mediated sedation for advanced endoscopic procedures. Wani S, Azar R, Hovis CE, et al.
Study Summary
J Gastrointestin Liver Dis. 2012; 21(2):165Y170.
Journal
8. Anti-hypertensive therapy and risk factors associated with hypotension during colonoscopy under conscious sedation. Tang DM, Simmons K, Friedenberg FK.
Title/Author
Table 4. Review of Selected Literature 2010–2013, Continued
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Procedure: ERCP
Tertiary referral centerVICD-related procedures
Evidence-based practiceVdefining sedation outcomes
Emergency room PSA by physicians
Single tertiary-care referral centerVendoscopic procedures
No benefit of TCI over PCS for this sample. Consider PCS dosing for endoscopic retrograde cholangiopancreatography related to ease of use, less propofol consumption, and faster recovery. Nurse-administered sedation for shorter ICD procedures such as single- and dual-chamber implants, generator changes, and defibrillation threshold testing had acceptable adverse event numbers. However, biventricular implants and other complex procedures should have an anesthesiologist. Longer procedures and biventricular implant were independent predictors of adverse events. International Sedation Task Force consensus document to solve the problem in sedation outcomes evaluation: no established definitions or language for sedation-related adverse events for reporting and benchmarking.
For 1402 patients, complications occurred in 3.5% of cases (n = 49). Deeper levels of sedation and procedures occurring at night were identified as risk factors for complications. Increasing BMI associated with increased airway maneuvers and hypoxemia (P G.001).
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Outpatient colonoscopy
Practice Area(s)
In a sample of 628 patients, for 158 patients taking antihypertensive therapy (regardless of class) within 24h of the procedure was not associated with increased risk for procedural hypotension.
Findings/Recommendations
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Outcomes for NAPS during routine endoscopic procedures in 215 patients with OSA.
Prospective evaluation of EDPS outcomes administered by physicians.
Compared the frequency of respiratory depression during EDPS with KP versus P. Also evaluated provider satisfaction, sedation quality, and total dose. All subjects were pretreated with intravenous fentanyl. Outcomes evaluation of 496 procedures for 340 patients with 358 unruptured aneurysms.
Comparison of PCS vs EPCS in the emergency department.
Review of published evidence to assess the safest most effective methods for procedural sedation in children having GIE. Search found 182 references; final review includes 11 RCTs and 15 non-RCTs.
Dig Dis Sci. 2011;56(9): 2666Y2671.
Am J Emerg Med. 2011;29 (5):541Y544.
Ann Emerg Med. 2011;57(5): 435Y441.
J Neurosurg. 2011;114(1):120Y128.
Ann Emerg Med. 2010;56(5): 502Y508.
J Pediatr Gastroenterol Nutr. 2012;54(2):171Y185.
15. Nurse-administered propofol sedation is safe for patients with obstructive sleep apnea undergoing routine endoscopy: a pilot study. Adler DG, Kawa C, Hilden K, Fang J.
16. ED procedural sedation of elderly patients: is it safe? Weaver CS, Terrell KM, Bassett R, et al.
17. A randomized controlled trial of ketamine/propofol versus propofol alone for emergency department procedural sedation. David H, Shipp J.
18. Neurointerventional procedures for unruptured intracranial aneurysms under procedural sedation and local anesthesia: a large-volume, single center experience. Ogilvy CS, Yang X, Jamil OA, et al.
19. A randomized controlled trial comparing patient-controlled and physician-controlled sedation in the emergency department. Bell A, Lipp T, Greenslade J, et al.
20. Safe and effective procedural sedation for gastrointestinal endoscopy in children. van Beek EJ, Leroy PL.
Emergency room
Hospital neurointervention
Incidence of respiratory depression was similarVKP was 22%, and P was 28%. Patients who received KP received less propofol with a trend toward improved sedation quality. Conscious sedation (local anesthesia) appears to be effective for most patients with unruptured intracranial aneurysms; also associated with shorter length of stay.
Literature review for pediatric best practices
Emergency room
For 864 observations, there were no significant differences in adverse events or complications by age. Only significant differenceVtotal sedative dose was lower for patients 965 y old.
Lack of RCTs that address effectiveness and safety. Limited evidence suggests that propofol based sedation may be best practice for children having GIE; however, evidence base is limited.
Hospital endoscopy
Procedures were accomplished more quickly with NAPS. No significant differences in complications or outcomes for OSA compared with non-OSA patients.
Emergency department
Ambulatory interventional spinal surgery center
Adverse events for conscious sedation 5.12% and for the local anesthesia 4.82% (no statistical difference). Patients in the local anesthesia group had higher rates of hypertension. No serious adverse events.
PCS safety, recovery, and satisfaction were similar to EPCS with a nonsignificant trend to lower total propofol dose. Adverse events and recovery time were not significantly different.
Practice Area(s)
Findings/Recommendations
Abbreviations: ASA, American Society of Anesthesiologists; BMI, body mass index; EDPS, emergency department procedural sedation; EPCS, emergency physician-controlled sedation; ERCP, endoscopic retrograde cholangiopancreatography; GA, general anesthesia; GIE, gastrointestinal endoscopy; ICD, implantable cardioverter-defibrillator; KP, ketamine and propofol; LACS, local anesthesia with conscious sedation; NAPS, nurse-administered propofol sedation; OSA, obstructive sleep apnea; PCS, patient-controlled sedation; P, propofol; PSA, procedural sedation and analgesia; RA, regional anesthesia; RCT, randomized controlled clinical trial; RN, registered nurse; STOP-Bang, Snoring? Tired? Observed? Pressure? Body mass index morethan 35 kg/m2? Age older than 50? Neck size large? Gender = male?; TAVI, transcatheter aortic valve implantation; TCI, target-controlled infusion.
Rate of adverse events using conscious sedation; 2494 cases reviewed; 1228 spine procedures used local and conscious sedation, 1266 had local anesthesia alone.
Study Summary
Spine J. 2011;11(12): 1093Y1100.
Journal
14. Adverse events of conscious sedation in ambulatory spine procedures. Schaufele MK, Mar
