Definition of Levels of Sedation

Several organizations have created guidelines and definitions of sedation for diagnostic and therapeutic procedures in children.^17–20 The definitions of the American Academy of Pediatrics (AAP), the American Society of Anesthesiologists (ASA), The Joint Commission (previously called the Joint Commission on Accreditation of Healthcare Organizations), and the American Academy of Pediatric Dentistry (AAPD) are the most frequently cited and agreed-upon position statements.^{18,19,21–23} These organizations defined sedation and analgesia for procedures as a continuum of consciousness to unconsciousness, ranging from minimal sedation (anxiolysis) to moderate sedation (previously, “conscious sedation”) to deep sedation and general anesthesia (Fig. 47-1). Note that a child’s depth of sedation may easily pass from a light level all the way to general anesthesia.²⁴

FIGURE 47-1 The sedation continuum. A patient may readily pass from a light level of sedation to deep sedation or general anesthesia. Health care providers must be prepared to increase vigilance and intensity of monitoring consistent with the depth of sedation.

A clear understanding of the definition of sedation is mandatory to recognize when the child has progressed to a deeper level of sedation than anticipated (i.e., from moderate sedation to deep sedation or from deep sedation to general anesthesia). Recognition of this transition allows escalation of monitoring and care to avoid complications. The AAP, ASA, and The Joint Commission formalized and defined the concepts of minimal sedation, moderate sedation, deep sedation, and general anesthesia. The definitions that follow are taken from The Joint Commission (2010)^25,26 and are in agreement with AAP, AAPD, and ASA definitions^18,19,21:

Painful procedures or nonpainful procedures requiring complete immobility (e.g., diagnostic imaging or radiation therapy) cannot be performed in a child who is moderately (“consciously”) sedated. Most pediatric procedures require deep sedation. The myth that a state of moderate sedation in which children are conscious and simultaneously responsive to voice command while immobile in the face of pain is just that, a myth.²⁷

Assessing the depth of sedation based on the child’s responses to stimulation is illustrated in Figure 47-2. This is a difficult challenge in children and depends on their verbal abilities, age, level of maturity, and underlying condition. A common problem with classifying a child as either moderately or deeply sedated is to misinterpret any movement in response to touch as “purposeful” and therefore a sign of “moderate sedation.” A child who is moderately sedated should respond to touch or firm rubbing by an appropriate response, such as saying “ouch,” pushing your hand away, and pulling up the covers. An inappropriate response, such as nonpurposeful movement, is a sign that the child has progressed to a deeper sedation level, which should lead to an escalation of care because respiratory depression may occur.^28–31 Similarly, children who are deeply sedated should respond purposefully to painful stimuli. Reflex withdrawal, a nonpurposeful response or no response to painful stimuli, is a sign that the child has progressed to a level of anesthesia and should be cared for using guidelines and personnel for general anesthesia. Children may quickly move from one level of sedation to another. A study in a large pediatric hospital showed that the goal of either moderate or deep sedation was only attained in 50% to 75% of patients. An awake state was noted in 12% to 28% of children, and a level consistent with general anesthesia was observed in up to 35% of children.³² The need for accurate assessment of the sedated child has brought about several scoring systems.

FIGURE 47-2 Sedated children must be continuously evaluated for depth of sedation and appropriateness of response. As diagrammed here, sedation is a continuum. Note that a purposeful response to voice or light touch is consistent with moderate sedation. A purposeful response to pain is consistent with deep sedation. A nonpurposeful response to pain is consistent with general anesthesia. However, such stimulation often defeats the purpose of the sedation, thus rendering these assessments less helpful unless patient movement is acceptable. None of the current sedation guidelines require such assessments.

*Purposeful: opens eyes, talks back, pushes you out of the way.

^†Nonpurposeful: winces, shrugs shoulders, nonspecific withdrawal to pain.

The Ramsay scale was described by Ramsay and colleagues³³ in 1974 for the purpose of monitoring sedation with alphaxalone-alphadolone (Table 47-1). It continues to be the most widely used scale for assessing and monitoring sedation in daily practice, as well as in clinical research. It spans the continuum of sedation but does not clearly separate purposeful from nonpurposeful responses. The Ramsey scale has been modified to more clearly coincide with the AAP and Joint Commission guidelines (Table 47-2).³⁴ A score of 2 to 3 is anxiolysis, 4 to 5 is moderate sedation, 6 is deep sedation, and 7 to 8 is general anesthesia.

TABLE 47-1 Ramsay Scale

TABLE 47-2 Modified Ramsay Sedation Scale

^*Minimal sedation.

^†Moderate sedation.

^‡Deep sedation.

^§General anesthesia.

The Observer’s Assessment of Alertness/Sedation (OAA/S) scale³⁵ is often cited as a scale for sedation. It is scored as follows: 1, no response to shaking; 2, responds to mild prodding; 3, responds to name called loudly; 4, lethargic response to name; and 5, readily responds to name. However, its inability to clearly categorize deep levels of sedation and lack of a clear differentiation between purposeful and nonpurposeful responses limit its usefulness. The University of Michigan Sedation Scale (UMSS)³⁶ is an assessment tool that has been shown to be valid when compared with the OAA/S scale and other scales of sedation (Table 47-3). It readily separates patients into the sedation categories defined by the AAP, ASA, and Joint Commission.

TABLE 47-3 University of Michigan Sedation Scale (UMSS)

These subjective, responsiveness-based assessment tools all have the disadvantage of intermittently stimulating the child during the procedure and thereby undoing the very reason that sedation was given in the first place! Poking or prodding the child to determine their depth of sedation defeats the purpose of sedation in many situations, e.g., infants, developmentally delayed, or procedures requiring immobility. None of the guidelines require this type of assessment. These responsiveness-based definitions are meant to provide a roadmap for safety, with the understanding that a nonresponding child requires an increased level of vigilance and the provider must have the skills to rescue should an adverse respiratory or cardiac event occur.¹² Concerns regarding these types of assessment tools have led to a drive by some to revise the sedation continuum and to use other monitoring to assess level of sedation.³⁷

To address the problem of defining the depth of sedation or anesthesia, a nonstimulating continuous-assessment tool using a processed EEG, as in the bispectral index (BIS) monitor, has been extensively explored. The BIS was derived from empirically estimating processed EEG parameters that best predicted OAA/S scale levels in adult volunteers receiving a wide variety of anesthetics, analgesics, and sedatives.³⁸ BIS values in adults range from 100 to 95, awake; 95 to 70, light to moderate sedation; 70 to 60, deep sedation with low probability of explicit recall; and 60 to 40, general anesthesia.³⁹ Unfortunately, the EEG in children varies markedly with age and drug, precluding accurate measures by the processed EEG.^40,41 Attempts to correlate BIS values with the depth of sedation in children have had varying success. In healthy children between 1 and 12 years of age who were sedated with chloral hydrate, meperidine and promethazine, midazolam, fentanyl, or pentobarbital, the BIS reading correlated well with the UMSS scores.⁴² In a similar study with children between birth and 18 years of age who received inhalational anesthetics, chloral hydrate, midazolam, and fentanyl,⁴³ the BIS readings validated the sedation scores, although the data identified several important limitations when distinguishing moderate from deep sedation. For example, the researchers concluded that a BIS of 80 is the optimal cutoff for a diagnosis of deep sedation although this value is inconsistent with that found in the adult literature. In children recovering from propofol and remifentanil anesthesia, there was a marked overlap between moderate and deep sedation using both the BIS and the composite A-line autoregressive index (auditory EEG).^44,45 From a safety perspective, it is worrisome that the BIS underestimates the depth of sedation with certain medications, such as chloral hydrate.^45,46 During pentobarbital sedation, the BIS had “limited ability to distinguish between moderate and deep sedation levels in children.”⁴⁷

Furthermore BIS values are not age specific,^48,49 may differ from one side of the head to the other, are diminished in developmentally delayed children,⁵⁰ may increase with larger doses of ketamine because of ketamine-induced central excitation,^51,52 and are unaffected even by high-dose dexmedetomidine.⁵³ Therefore the overlap between levels of sedation, the few large well-controlled studies in children, the overall low quality of BIS data in some studies, as well as a lack of information for different age-groups and specific drugs, precludes validation of the BIS for use in sedated children.⁴⁰ In addition, the use of BIS-type monitoring is not feasible for many procedures, such as MRI, CT scans, or those involving the mouth and airway (endoscopy, dental, bronchoscopy), because the monitor is either not compatible, creates artifacts, is easily dislodged, or is in the way of the proceduralist.

The definitions and tools discussed previously attempt to assess sedation and decrease risk by quantitating the response to stimulation or EEG activity. These tools, however, do not directly measure the risk of loss of control of the airway, which is the primary cause of morbidity and mortality during sedation.^54,55 The implication is that there is a direct quantifiable correlation between response to touch or painful stimulation and the ability to control the airway. Thus a moderately sedated child who can respond to light touch can protect his or her airway and a deeply sedated child who can respond appropriately only to pain may not be able to protect his or her airway. The important assessment of the child is not the response to stimulation, but the ability to protect the airway. Furthermore, different sedative drugs have different effects on analgesia separate from obtundation of the airway. Propofol is not a profound analgesic but has profound effects on the airway.⁵⁶ Conversely, the sedative dexmedetomidine may provide profound sedation with little depression of respiratory function. Ketamine produces intense analgesia and most children maintain a patent airway and adequate respiratory effort (Table 47-4).⁵⁷

TABLE 47-4 Examples of Sedative Drugs That Have Varying Effects on Response to Pain and Airway Protection

↓↓↓, Large decrease in response to pain or large effect on airway patency; ↓, some decrease in response to pain or some effect on airway patency; ±, minimal to no effect on response to pain or effect on airway patency; +, no effect on airway patency.

Until recently, a quantifiable metric to assess control of the airway in sedated children was not available.⁵⁸ Studies on the changes of airway dimensions under different anesthetic and sedative agents, the effect of different positions on the upper airway,^59–61 and upper airway collapsibility with different concentrations of sedative drugs provide a more meaningful assessment of airway risk and protection. The profound effect of propofol-induced collapse of the upper airway can be partially mitigated by reducing the dose and including supplemental drugs, such as midazolam and nalbuphine.^62,63

Assessing sedation must also focus on appropriate discharge readiness. Adverse effects, including death, have occurred after premature discharge following sedation for a procedure.⁵⁵ These events have occurred most often when a long-lasting (long half-life) sedative, such as chloral hydrate, has been given (Fig. 47-3). This can result in the child being unable to spontaneously clear his or her airway.⁵⁴ A simple modified “maintenance of wakefulness” score (infants had to stay awake for at least 20 minutes in a quiet environment before discharge) ensured that more than 90% of children had returned to baseline, compared with only 55% of children assessed as “street ready” according to usual hospital discharge criteria.⁴⁴

FIGURE 47-3 β-Elimination half-life of the active metabolite of chloral hydrate, trichloroethanol, in preterm infants, term infants, and toddlers. Note the extremely prolonged half-lives and the large standard deviations in all age groups. Although often thought of as a short-acting sedative, chloral hydrate can have profoundly long sedative effects, with a real possibility of re-sedation after a procedure when the child is left undisturbed. It is for this reason that we recommend a longer period of observation in a step-down area before discharge.

Goals of Sedation

The goals of pediatric sedation have not changed over the years and can be summarized as follows^18,31:

Risks and Complications Associated with Sedation

The foremost goal is to optimize patient safety and thereby decrease the risk and associated complications. The assessment of risk for pediatric sedation must include age, type of procedure, underlying medical conditions and how these might influence the response to sedating medications, intended level of sedation, pharmacology (pharmacokinetics [PK] and pharmacodynamics [PD]) of the medications used, guidelines (i.e., training, equipment, personnel, monitoring), appropriate-for-age fasting, and strict discharge criteria.

A recent area of concern that was not previously recognized in providing safe sedation or anesthesia to small children is whether drugs used for sedation or anesthesia are neurotoxic to children^64–71; this topic is covered in detail in Chapter 23. More important than the theoretical concern regarding potential neurotoxicity of sedating medications is the more practical risk assessment regarding both inadequate and excessive sedation. Sedation centers in the United States are less likely to offer sedation for painful procedures than similar centers in Europe. Thirty percent of U.S. respondents to a mail survey reported performing bone marrow biopsies in children without significant sedation more than 50% of the time, as compared with 0% of European centers!⁷² When 1140 children (mean age 2.96 ± 3.7 years) were sedated by nonanesthesiologists who followed AAP guidelines for procedures,⁷³ approximately 13% received inadequate sedation.

The psychological consequences of inadequate sedation have not been specifically studied but can be inferred from children’s responses to other stressful situations. Inadequate preoperative sedation is clearly linked to increased anxiety in children and their families. Of children undergoing a stressful anesthesia induction, 54% have postoperative maladaptive behaviors for up to 2 weeks after the experience.⁷⁴ The incidence of these behaviors decreases with the use of appropriate preoperative sedation. Similar sequelae have been reported after repeated invasive procedures in pediatric intensive care units (ICUs).⁷⁵ Although the number of children who developed posttraumatic stress syndrome because of no sedation or less than optimal sedation during diagnostic and therapeutic procedures is unknown, one can assume that it would be similar to that found in the study situations.

There have been many approaches to assess the risk involved in oversedation of children. One approach is to review sedation-related deaths and critical incidents to find common causes. In 2000, a now classic retrospective review was undertaken of 95 cases of sedation-related deaths and critical incidents derived from the U.S. Food and Drug Administration’s (FDA) adverse drug event reporting system, the U.S. Pharmacopeia, and a survey of pediatric specialists.⁵⁴ Although a number of the incidents cited in this study occurred over 20 years ago, the findings remain applicable today. The analysis revealed that, rather than being related to a specific medication, the overwhelming majority of critical events were preventable and caused by operator error or lack of robust rescue systems. Drug interactions were the most common factor, followed by drug overdose, inadequate monitoring, inadequate cardiopulmonary resuscitation skills, inadequate evaluation before sedation, and premature discharge from medical supervision. The report emphasizes that most sedation complications are related to adverse respiratory events (80%); a majority progressed to cardiac arrest, indicating a lack of rescue skills of the practitioners. A disproportionately large number of severe complications and deaths occurred when sedation was performed in offices outside of hospitals, pointing to a lack of trained personnel available for rescue. There was no relationship with class of drug or route of administration, although there was a positive correlation when three or more sedating medications were administered.⁵⁵ Indeed, the combination of a sedative, hypnotic, and an opioid is well recognized as a precursor to significant respiratory depression.

There are many underpowered reports with relatively few patients (n <200) receiving a variety of sedative medications in a variety of settings declaring successful completion of the procedures and no fatalities.^76–86 Most studies describe adequate conditions and successful completion with no severe outcomes, but with varying frequencies of transient airway obstruction or desaturation. Conclusions often state that the particular technique and sedation providers are safe and effective. An example is a study that prospectively followed 1140 children (mean age 2.96 ± 3.7 years) sedated for procedures by nonanesthesiologists following AAP guidelines and using a quality-assurance tool.⁷³ Neither death nor sedation-induced crises occurred, although they reported a 5.3% incidence of respiratory events, including one in which a child developed apnea. Given that the expected incidence of a sedation-induced crisis should be on the order of one in tens of thousands, it is not surprising that the majority of similar studies are underpowered to report a critical event.⁸⁷

Another approach to assessing safety is to carefully observe relatively small groups of children and track minute-to-minute changes in their level of sedation. This has been accomplished by the creation of the Dartmouth Operative Conditions Scale (DOCS) (Table 47-5).⁸⁸ This scale was derived from observing 110 videos of pediatric sedation outside the OR. The DOCS quantifies the child’s “state” based on observable behavior. Continuously applying this scale allows for careful tracking of level of sedation, effectiveness of sedation, uncontrolled adverse effects, and the timing of induction of sedation and recovery without poking or prodding the child to determine their depth of sedation. These data can help to quantify the quality of sedation and best practices.

Simulations have been used to carefully examine rare adverse effects in pediatric sedation and ability to rescue.^89,90 In a simulated scenario of a sedation complication, a standard reproducible event was introduced in which physiologic variables degraded with inappropriate interventions and improved when effective treatment was introduced. The simulation was distributed throughout the hospital and used with different sedation provider teams (e.g., postanesthesia care unit, emergency department [ED], radiology, and sedation unit). The event was videotaped and scored based on deviations from best practice; it quantifies episodes of hypoventilation, apnea, hypoxia, and cardiovascular collapse. Hypoxia and hypotension lasted 90 seconds in the pediatric sedation unit and 360 seconds in the ED and radiology setting.⁹¹ Such studies demonstrate that prospective and retrospective analysis of simulated but rare adverse events can identify areas within the hospital that are in need of improving their clinical skills, and have a positive impact on patient safety.

There has been a recent effort to capture information from the large numbers of pediatric sedation procedures necessary to understand the nature and frequency of adverse reactions to sedation. The Pediatric Sedation Research Consortium (PSRC) comprises a group of over 30 institutions in North America who share prospective data on pediatric sedation.¹⁴ Analysis of the first 30,000 records identified demographics, procedures, sedation techniques, outcomes, and adverse events: (1) there were no deaths and only one cardiac arrest reported; (2) unanticipated admission occurred infrequently, 1 per 1500 sedations; (3) vomiting occurred 1 per 200 sedations, including one aspiration; (4) stridor, laryngospasm, wheezing, and apnea occurred in 1 of 400 procedures; and (5) airway or ventilatory manipulations occurred in 1 time per 200 sedations.⁹¹ Risk factors included age younger than 3 months, ASA physical status 3 or greater, and multiple drug combinations for sedation. The PSRC has also reviewed the incidence of adverse events in 49,386 propofol sedation and/or anesthesia encounters for procedures outside of the OR.¹⁵ Propofol was delivered by multiple providers (anesthesiologists, intensivists, emergency medicine, pediatricians, and radiologists). No deaths were recorded. CPR was required in 2 children (anesthesiologists were not involved in their care) and aspiration occurred in 4 children. Desaturation of less than 90% for more than 30 seconds occurred 154 times per 10,000 sedations/anesthesias; central apnea or obstruction occurred 575 times per 10,000. Stridor, laryngospasm, excessive secretions, and vomiting occurred 50, 96, 341, and 49 times per 10,000, respectively. The most prominent type of complication was related to the airway and occurred 1 out of 65 sedations; 1 in 70 children required airway rescue. Unexpected admissions occurred 7.1 times per 10,000 sedations. When all possible adverse events are considered, anesthesiologists report fewer events than nonanesthesiologists, with an odds ratio of 1.38 (95% confidence interval [CI] of 1.21 to 1.57, P < 0.001).¹⁵ No difference, however, was noted when outcomes were limited only to major pulmonary complications. The authors concluded that propofol sedation and/or anesthesia when given under these strict organized conditions, i.e., following the AAP sedation guideline, with very well-trained providers, can result in effective sedation with a minimal incidence of severe adverse events. The safety of this practice is contingent on the ability to quickly and safely manage less serious events. In a prospective cohort study of 131,751 procedural sedations⁹² in radiology (62%), hematology–oncology (11%), and minor medical or surgical procedures (16%), in which sedation included primarily propofol (60%), midazolam (25%), and others provided by anesthesiologists, emergency physicians, intensivists, pediatricians, and “other” (pediatric residents, radiologists, dentists, surgeons, and nurses), the rate of major complications per 10,000 sedations (and 95% CIs) were: anesthesiologist 7.6 (4.6 to 12.8), emergency physician 7.8 (5.5 to 11.2), intensivist 9.6 (7.3 to 12.6), pediatrician 12.4 (6.9 to 20.4) and “other” 10.2 (5.1 to 18.3). There were no statistical differences between any providers before or after potential confounding variables (age, ASA status, fasting status, propofol use). A significant limitation of the study was the selection bias that was introduced because not all sedation areas within each hospital reported data and the providers were not randomized. The study did not track whether high-risk patients were referred to practitioners outside of their sedation practice (i.e., the anesthesia service). Only major complications and not minor but dangerous complications (i.e., desaturation, hypoventilation, and need for airway support) were monitored. The participants in these hospitals are highly motivated, and application of these data outside of the consortium requires rigorous evaluation of safeguards and training. The ASA thinks that anesthesiologist participation in all deep sedation is the best means to achieve the safest care. The ASA acknowledges that nonanesthesiologists administer or supervise the administration of deep sedation and has created guidelines to help anesthesiologists provide leadership in this area.^93,94

Guidelines

The first sedation guidelines were published in 1985 from the Committee on Drugs, Section on Anesthesiology, American Academy of Pediatrics.⁹⁵ These guidelines provided the first framework to improve safety for children requiring sedation for a procedure. The guidelines emphasized systems issues, such as the need for informed consent, appropriate fasting before sedation, frequent measurement and charting of vital signs, the availability of age- and size-appropriate equipment, the use of continuous physiologic monitoring, the need for basic life support skills, as well as proper recovery and discharge procedures. The guidelines stated that an independent observer whose only responsibility was to monitor the child was required for deep sedation. Advanced airway and resuscitation skills were encouraged but not required. In 1992, the guidelines were revised⁹⁶ emphasizing that a child could readily progress from one level of sedation to another and that the practitioner should be prepared to increase vigilance and monitoring as indicated. In 2002, the same Committee on Drugs of the AAP updated and amended the guidelines.⁹⁷ It eliminated the use of the confusing term conscious sedation and replaced it with the term moderate sedation. It also emphasized the application of these guidelines outside the hospital, in recognition of the relatively high complication rate in non–hospital-based settings. The ASA guidelines in use today were updated in 2002 and, in many respects, modeled after the AAP guideline.⁹⁸ These guidelines were systematically developed by a task force of 10 members. The task force reviewed the strength of evidence and made recommendations that include the following:

FIGURE 47-4 Relationship between ventilation and carbon dioxide is represented by a family of curves. Each curve has two parameters, an x-intercept and a slope. Sedatives and opioids increase the intercept and decrease the slope. The combination of sedatives and opioids produce the most profound effect.

(From Yaster M, Nichols DG, Deshpande JK, Wetzel RC. Midazolam-fentanyl intravenous sedation in children: case report of respiratory arrest. Pediatrics 1990;86:463-7.)

TABLE 47-6 Guidelines for the Consultation of an Anesthesiologist

ASA, American Society of Anesthesiologists; BMI, body mass index.

The above ASA guideline pertains to all age-groups. The AAP’s most recent guideline update was published in 2006.¹⁸ In general, their updated guideline reinforces the ASA guideline. The AAP updated revision retains the same definitions of the continuum of sedation that are identical to the ASA and Joint Commission definitions. The AAP guidelines emphasize a systematic approach to sedation that includes:

Other organizations, including the American College of Emergency Physicians (ACEP), published their own sedation guidelines.^101–105 The latter guidelines are distinguishable from the AAP and ASA guidelines in several respects, including the definition of the continuum of sedation. The ACEP guideline does not use the terms “moderate” or “deep” sedation but rather the term “procedural sedation.” It is defined “as a technique of administering sedatives, analgesics, dissociative agents, alone or in combination to induce a state that allows the child to tolerate unpleasant procedures while maintaining cardiopulmonary function.” It is intended to result in a depressed level of consciousness but one that allows the child to “independently and continuously” control their own airway. Unfortunately, the lack of uniform agreement on definitions and overlap of “procedural sedation” into “deep sedation” and “anesthesia” has led to considerable confusion and debate among practitioners. In 2006 the ASA asserted that “privileges to administer deep sedation should be granted only to practitioners who are qualified to administer general anesthesia.”^93,94 Intensivists and emergency room physicians took umbrage with the ASA “usurping” control over their sedation practice.¹¹ They pointed out that their specialties have been using drugs, such as propofol and ketamine, for procedural sedation with minimal complications at levels that are considered deep sedation or anesthesia for many years,^106,107 and that they resent an outside organization imposing guidelines on their practices. In 2010 the ASA acknowledged that Medicare regulations permit some non–anesthesia practitioners to administer deep sedation and created guidelines to help hospital directors of anesthesia services grant privileges to such individuals.⁹³ The guidelines include: formal training in administration of deep sedation during residency training (within 2 years) or an Accreditation Council for Graduate Medical Education accredited training program; experience and competency in managing sedated patients; clinical experience with more than 35 patients; knowledge of ASA guidelines; advanced cardiac life support training; and quality assurance tracking. Separate privileging is required for the care of children. The exact nature of these requirements are not specified, but are over and above baseline competencies and dependent on the hospital’s director of anesthesia services.

It is mandatory that sedation policies used in hospitals conform to Joint Commission standards that have been derived from the Department of Health & Human Services (DHHS) Centers for Medicare & Medicaid Services (CMS). In the 1990s, the Joint Commission recognized that there is considerable variation in the level of care provided to sedated children, depending on where the sedation is administered, even within one institution. They mandated that the standard of care for all sedated patients be uniform throughout any one institution Thus institutionally standardized documentation (e.g., medical history, physical status, and record-keeping during the procedure and the recovery from the procedure), fasting guidelines, and informed consent procedures are mandatory for all patients undergoing sedation, regardless of the nature, duration, patient’s history, and location of the procedure. Similarly, the sedation personnel, monitoring equipment, and recovery facilities must be standardized or uniform within an institution. All of this must be part of an active quality improvement process. Hospitals risk losing federal funding if they fail to comply. In 2004, 18% of hospitals were found noncompliant in planning the administration of moderate or deep sedation.¹⁰⁸ In the most recent Joint Commission regulations, 2010,²⁵ the leadership and responsibilities for the delivery of deep sedation fall on the shoulders of the anesthesia department (Fig. 47-5).

FIGURE 47-5 Centers for Medicare & Medicaid Services organizational chart showing deep sedation under the category of “Anesthesia” and supervised by “Hospital Sedation Services.” CRNA, Certified registered nurse anesthetist; MAC, monitored anesthesia care; MD, physician.

Deep sedation is placed under Anesthesia and subject to the anesthesia administration requirements at 42 CFR 482.52(a): whereas minimal and moderate sedation are placed under analgesia/sedation and therefore not subject to anesthesia administration requirements. CMS states that one anesthesia service has authority and responsibility of all anesthesia services throughout the institution. Anesthesia must be administered by a (1) qualified anesthesiologist; (2) CRNA (certified registered nurse anesthetist) or AA (anesthesiologist assistant) with appropriate supervision; (3) doctor of medicine or osteopathy (other than an anesthesiologist); and (4) dentist, oral surgeon, or podiatrist who is qualified to administer anesthesia under state regulations. Credentialing and privileging must be done per hospital policy and is the responsibility of the hospital’s director of anesthesia services. The appropriateness and quality of anesthesia, including sedation, must be reviewed and approved by the director of anesthesia services.

Specific standards for sedation are mentioned in Provision of Care, Treatment and Services (PC.03.01.01, .03, .05 .07), Improving Organization Performance (PI.01.01.01), and records (RC.02.01.03).²³ These standards address moderate and deep sedation, as well as anesthesia services. The standards require that each hospital develop specific appropriate protocols for patients receiving sedation. These protocols must be consistent with professional standards and address the following: