Using BIS Monitoring to Reduce the Incidence of Intraoperative Awareness

Implementing the ASA Practice Advisory: An Algorithm-Based Approach

In October 2005, the American Society of Anesthesiologists adopted the Practice Advisory for Intraoperative Awareness and Brain Function Monitoring.* The approval of this Advisory by the ASA signals a heightened concern regarding intraoperative awareness and establishes an important role for brain monitors within anesthesia practice. The Practice Advisory recommends that anesthesiologists and other professionals administering general anesthesia should assess the awareness risk profile for each patient preoperatively. Patients considered at increased risk should be informed of the possibility of intraoperative awareness. The Advisory advocates using multiple monitoring modalitiesclinical techniques, conventional monitoring, and brain function monitoringto assess anesthetic depth and reduce the likelihood of intraoperative awareness. The Advisory includes a systematic review of the scientific evidence revealing that only BIS monitoring has been demonstrated to reduce the incidence of awareness. Sixty-nine percent of ASA members surveyed as part of the Advisory agreed, or strongly agreed, that brain function monitors are valuable and should be used in patients at risk. Although the Advisory states that brain monitoring is not indicated for all patients, the Advisory concludes that the decision to use a brain function monitor should be made on a case-by-case basis for selected patients.
This document provides: An overview of the ASA Practice Advisory A clinical algorithm to reduce the incidence of awareness (Figure 1) An evidence-based assessment of the BIS monitoring solution An Appendix describing the clinical integration of BIS monitoring into anesthesia care

Practice Advisory for Intraoperative Awareness and Brain Function Monitoring Approved by ASA House of Delegates, October 2005. Available at: www.ASAhq.org.

Figure 1

AVOIDING AWARENESS ALGORITHM

Preoperative Patient Assessment

Previous episode of awareness Anticipated tolerance to opioids or sedatives Known or anticipated difficult airway Known or anticipated hemodynamic instability Surgical procedure with increased risk of awareness

Anesthesia Management Plans

Muscle relaxant use during maintenance phase Reduced anesthetic doses during paralysis Total intravenous anesthesia Nitrous oxideopioid anesthesia

Does Patient Have Risk Factors for Awareness?

Inform patient of possibility of awareness

YES

Consider prophylactic administration of benzodiazepine

Use Multiple Modalities to Monitor Depth of Anesthesia to Minimize Occurrence of Awareness

Clinical Signs Patient observation - Movement - Lacrimation - Sweating Conventional Monitoring Blood pressure Heart rate Respiratory rate End-tidal agent Brain Function Monitoring Multiple technologies available Only BIS has data demonstrating 80% reduction in awareness

Clinical Considerations
Use of NMB agents may mask somatic signs Lack of studies measuring ability to reduce occurrence of awareness Avoiding paralysis does not prevent awareness Cardiovascular medications (e.g., beta-blockers) may mask signs Lack of studies measuring ability to reduce occurrence of awareness Awareness may occur with normal vital signs GOAL: BIS < 60 - Initiate prior to induction - Non anesthetic factors may influence BIS value Awareness with BIS has been reportedtypically with BIS > 60

ASA Practice Advisory: An Overview The ASA Practice Advisory confirms that intraoperative awareness is an important clinical problem, occurring in 0.1%0.2% of patients, that has the potential for causing significant psychological injury.1,2 The Practice Advisory aims to assist decision making in patient care by (1) identifying the risk factors associated with intraoperative awareness, (2) providing tools to enable anesthesia professionals to reduce the frequency of awareness, and (3) providing guidance on the intraoperative use of brain function monitors. Each of these areas is addressed within the Practice Advisory. An overview of various perioperative factors that put patients at increased risk for awareness is presented in Table 1.
Table 1

perioperative periodpreoperative assessment and preparation, intraoperative monitoring and intervention, and postoperative follow-up activities. An overview of the resulting practice strategy is presented in Table 2. A key tenet of the Practice Advisory is that intraoperative monitoringfor the purpose of minimizing the occurrence of awarenessshould rely on multiple modalities to assess depth of anesthesia. These modalities may include observation of clinical signs (e.g., movement), conventional monitoring systems (hemodynamic and respiratory monitoring, anesthetic agent analysis), and brain function monitoring. The Advisory further states, the use of neuromuscular blocking drugs may mask purposeful or reflex movements, and adds additional importance to the use of monitoring methods that assure the adequate delivery of anesthesia. It is in this particular area of care that brain function monitors add clear value to patient assessment. As the Advisory notes, brain function monitors are dedicated to the assessment of the effects of anesthetics on the brain, and provide the anesthesia professional with additional information regarding the adequacy of anesthetic depth. This concept of multiple modalities to enhance overall vigilance is not new. Anesthesia professionals routinely use multiple methods, such as capnography, pulse oximetry, airway presThe use of neuromuscular sure monitoring, and disconnect blocking drugs may mask alarms to assess the adequacy of purposeful or reflex moveventilation and oxygenation. ments, and adds additional importance to the use of The Practice Advisory concludes monitoring methods that that the decision to use a brain assure the adequate function monitor should be made delivery of anesthesia. 1 on a case-by-case basis by the individual practitioner for selected patients. This decision should be guided by the available evidence of clinical efficacy as well as the Advisory documentation of peer-based opinion surveys. Notably, results show significant alignment of consultant and ASA member responses to the statement: Brain function monitors are valuable and should be used to reduce the risk of intraoperative awareness for patients with conditions that may place them at risk for intraoperative awareness.
Figure 2

POTENTIAL RISK FACTORS FOR AWARENESS

PATIENT AND ANESTHETIC HISTORY Previous episode of awareness Substance use or abuse Chronic pain patients on high doses of opioids History of, or anticipated difficult intubation ASA physical status 4-5 Limited hemodynamic reserve SURGICAL PROCEDURES Cardiac surgery Cesarean section Trauma surgery Emergency surgery ANESTHETIC MANAGEMENT Planned use of: - Muscle relaxants during maintenance phase - Total intravenous anesthesia - Nitrous oxideopioid anesthesia Reduced anesthetic doses during paralysis

It is notable that the presence of some of these risk factors has been reported to increase the relative risk of awareness to nearly 1% of patients. The Practice Advisory provides guidance that will help the anesthesia professional to develop a practice strategy that minimizes the occurrence of awareness. Such a strategy must involve elements of care occurring throughout the
Table 2

PRACTICE STRATEGY TO MINIMIZE AWARENESS

PREOPERATIVE PERIOD Assess risk (Patient, procedure and anesthetic technique) Provide informed consent in high-risk situations INTRAOPERATIVE PERIOD Consider premedication to provide amnesia Use multiple modalities to assess anesthetic depth - Clinical signs (Masked with use of muscle relaxant) - Conventional monitoring (BP, HR, end-tidal agent) - Brain function monitoring (e.g., BIS) Consider amnestics for unintended consciousness POSTOPERATIVE PERIOD Assess patient reports of awareness Provide patient with appropriate follow-up care Report occurrence for quality assurance purposes

ASA MEMBER SURVEY: BRAIN MONITORING ROLE

Brain function monitors are valuable and should be used to reduce the risk of intraoperative awareness for patients with conditions that may place them at risk for intraoperative awareness.

1% 10% 19% 48%

Strongly agree

21%

Agree Uncertain Disagree Strongly disagree

Sixty-nine percent of ASA members surveyed and 63% of consultants agreed or strongly agreed with that statement (Figure 2). One approach to brain function monitoring may involve prioritizing brain monitor use to patients recognized to be at increased awareness risk, as suggested by the survey responses. The Practice Advisory identifies many specific patient issues, surgical procedures, and anesthetic management techniques associated with increased risk for awareness. This assessment framework thereby establishes relative indications for the addition of brain function monitoring to existing methods of patient assessment and intraoperative monitoring. Although one focus of the Practice Advisory is the role of brain function monitoring in reducing the occurrence of awareness, the systematic review of the scientific literature revealed the substantial number of studies that demonstrate the ability of BIS monitoring to influence other important clinical outcomes. Anesthesia professionals should consider these outcomes, in addition to the potential role for reducing awareness, as they make their decision regarding utilization of brain function monitoring. BIS Monitoring: An Evidence-Based Assessment The clinical evidence supporting the intraoperative use of BIS monitoring and validating its impact on reducing the incidence of awareness is extensively documented in the ASA Practice Advisory. In fact, as readers of the Advisory will see, BIS monitoring is the only clinical intervention that has been shown to be effective in prospective clinical trials. Although many components of suggested clinical practice, such as premedication with benzodiazepines, hemodynamic monitoring, and end-tidal agent monitoring, are described in the Practice Advisory, the document notes that the clinical efficacy of these interventions remains unproven: No clinical trials or other comparative studies were found that examine the effect of clinical techniques or conventional monitoring on the incidence of intraoperative awareness. No clinical trials or other comparative studies were found that examine the effect of clinical techniques or conventional monitoring on the incidence of intraoperative awareness. 1 Similarly, the Practice Advisory specifically notes that the six other brain function monitors on the market today (Entropy, Patient State Analyzer, SNAP II, Narcotrend, Cerebral State Monitor, AEP Monitor/2) lack clinical trials assessing the ability of these monitoring technologies to influence the incidence of intraoperative awareness. The Practice Advisory also comments upon important differences between various brain function monitoring technologies: . . . the values generated by individual devices in any given anesthetic state differ among the various monitoring technologies.

This caveat has important implications for anesthesia professionals. Different device values are not interchangeable; therefore, it would be inappropriate to assume that the clinical research findings from one device (e.g., clinical evidence related to BIS-managed anesthesia) can be extrapolated to other devices. Similar conclusions have been expressed elsewhere by experts in the field.3,4 Two large-scale, prospective trials documenting an 80% reduction in the incidence of awareness while using BIS monitoring in both highrisk and general popuUse of BIS monitoring to help lation patients receiving guide anesthetic administration may relaxant general anesbe associated with the reduction thesia provide substanof the incidence of awareness with tial evidence supporting recall in adults during general BIS efficacy (Figure 3). anesthesia and sedation. This evidence served as From "Indications for Use," Aspect A-2000 the basis for a unique 510(k) #031694. expanded indication for use for BIS technology in 2003. These investigations provide a framework for clinical management incorporating BIS monitoring in a strategy to help reduce the incidence of awareness. Ekman and colFigure 3

BIS USE REDUCES AWARENESS Awareness in a general population

0.2%

14 / 7,826

0.1% 2 / 4,945 0.0%

Historical Control BIS
Ekman A, et al. Acta Anaesth Scand. 2004;48:20-26.

Awareness in a high-risk population

1.0% 0.8% 0.6% 0.4% 0.2% 0.0%

11 / 1,238

2 / 1,225

Control

BIS

Myles PS, et al. Lancet. 2004;363:1757-1763. Both studies demonstrate that when BIS is maintained within a range of 40 to 60, there is a consistent 80% reduction in the occurrence of awareness.

leagues measured the impact of adjuvant BIS monitoring in a series of 4,945 consecutive patients in a clinical trial designed to examine the value of BIS monitoring in routine clinical care.5 The anesthesia staff was instructed to maintain BIS values between a range of 40 and 60, and to avoid values greater than 60 during induction and maintenance. This strategy resulted in significant benefit: the incidence of awareness with explicit recall was 0.04% (2 patients in the 4,945 treated patients). The authors noted: The present incidence of awareness is the lowest ever reported in a reasonably large study using muscle relaxants.5 This incidence rate represented a 77% reduction when compared with a previously reported incidence of The present incidence of awareness established in awareness is the lowest ever a similar patient populareported in a reasonably large 5 tion at these institutions by study using muscle relaxants. the same investigators. Myles and colleagues conducted the B-Aware trial to document the efficacy of adjuvant BIS monitoring in patients at increased risk for awareness.6 In this prospective, randomized trial, 2,463 patients were either managed with traditional forms of preoperative assessment, medication and intraoperative monitoring, or provided similar care with the addition of BIS monitoring. BIS monitoring was initiated prior to induction, and the delivery of anesthetics
Figure 4

was titrated to maintain BIS values between 40 and 60 from laryngoscopy until wound closure. Results showed nearly a five-fold reduction (82%) in the incidence of awareness, similar to the Ekman study. In these high-risk patients, the incidence of awareness decreased from 0.91% in the control group to 0.18% in the BIS-monitored group. Significantly, the authors concluded: We have shown that use of BIS monitoring can reduce the incidence of awareness under general anaesthesia in patients at risk, suggesting that greater use of BIS monitoring is warranted in patients at increased risk of awareness undergoing relaxant general anaesthesia.6 In each study, two episodes of awareness In conclusion, we have shown that were reported in use of BIS monitoring can reduce patients despite the use the incidence of awareness under of BIS monitoring. The general anaesthesia in patients at individual case trends risk, suggesting that greater use of are instructive regardBIS monitoring is warranted in ing the timing of awarepatients at increased risk of awareness as well as the BIS ness undergoing relaxant general response. As shown in anaesthesia. 6 Figure 4, all four cases of awareness occurred during periods of significant stimulation (i.e., intubation, rigid bronchoscopy, or sternal split) and were associated with BIS values near or greater than 60. Importantly, each of the elevated BIS values occurred over a brief

INTRAOPERATIVE AWARENESS DURING BIS MONITORING

100 80 60
BIS
Awareness (A)

100 80 60
BIS
Awareness (B)

40 20 0 8:31 100
Awareness (C)

40 20 0 11:07 100 80 60
Awareness (D)

9:01
Time

9:31

10:01

11:37
Time

12:07

12:37
BIS profile trends from four cases of intraoperative awareness occurring despite use of BIS monitoring. Intraoperative awareness in each case was associated with BIS values near or greater than 60 at time of significant noxious stimulation, such as intubation (A & B), rigid bronchoscopy (C), or sternotomy (D). (Modified from References 5 & 6).

80 60
BIS BIS

40 20 0 10:11

40 20 0 7:48

10:41
Time

11:11

11:41

8:18
Time

8:48

9:18
5

period, when attention may have been focused on other aspects of patient care. These cases highlight the need for the anesthesia professional to be particularly vigilant to BIS values during periods of stimulation and to be prepared to intervene when BIS values exceed 60 for some time. Similarly, in another study cited in the Advisory, no cases of awareness with BIS values less than 60 could be identified. This further demonstrates that when BIS values are maintained below 60, the risk of awareness can be substantially reduced. In isolated cases, intraoperative awareness has been reported to occur despite BIS values less than 60. A Case-by-Case Decision The Practice Advisory states that although brain monitoring is not indicated for all patients, the decision to use a brain function monitor should be made on a case-by-case basis by the individual practitioner for selected patients. Indeed, there are certain surgical procedures on the face or forehead that may preclude placement of the BIS sensor. It also concludes that it is the opinion of the Task Force that brain function monitors currently have the same status of the many other monitoring modalities that are currently used in selected situations at the discretion of the individual clinician. The adoption of these statements and their interpretation into clinical practice have many parallels to other monitors frequently used by anesthesia professionals. For example, the utilization of direct arterial blood pressure monitoring (art line) in the care of selected patients depends on a variety of patient, procedure, or anesthetic technique factors. In some situations, almost every anesthesia clinician would likely elect to use this monitor (e.g., cardiac surgery, carotid endarterectomy). In other situations, the decision may not be as clear-cut, but many clinicians would favor use (e.g., a major intra-abdominal procedure in an ASA 4 patient). With the adoption of the Practice Advisory, practicing anesthesia professionals will need to determine their own threshold for utilizing a brain monitor as they assess each patient situation. Taken as a whole, the Practice Advisory clearly suggests the need for a decision assessment regarding the use of brain monitoring in every case. Because the available clinical evidence demonstrates a decrease in the frequency of awareness in high-risk patients monitored with BIS, and ASA survey data demonstrates that two-thirds of anesthesiologists believe brain function monitors should be used in patients at risk, the individual practitioner should carefully consider these factors when developing an anesthetic plan for each individual patient. Equally important, individual anesthesiologists will have to address their own practice environment. To follow the 6

recommendations of the Advisory, access to proven brain monitoring technology in any operating room where an at-risk patient may receive anesthesia care assumes considerably greater importance than it did prior to the Advisory. Only with access to the right equipment and technology will anesthesiologists and other anesthesia professionals be in a position to implement an anesthesia care and monitoring plan that is relevant to the needs of each patient, and that will lead, in turn, to improved patient outcomes and safety. Based upon the ASA Practice Advisory, an algorithm approach to minimizing the risk of awareness is presented (Figure 1).

C O N C L U S I O N The ASA Practice Advisory for Intraoperative Awareness and Brain Function Monitoring provides important new guidance regarding the identification and most appropriate care of patients deemed to be at increased risk of awareness. However, it must be recognized that some patients, even without such recognized preoperative risk factors, may still experience awareness due to changing and/or unanticipated intraoperative conditions. The decision to use a brain function monitor in a particular patienteven with the available Practice Advisoryis a complex one based on a variety of considerations, as discussed in a recent Presidential Update to ASA members.* Clinicians should utilize multiple modalities, including BIS monitoring, to assess depth of anesthesia and minimize the risk of awareness, and may wish to consider an algorithm approach to minimizing the risk of awareness.

References
1. Practice Advisory for Intraoperative Awareness and Brain Function Monitoring Approved by ASA House of Delegates, October 2005. Available at: www.ASAhq.org. 2. Sebel PS, Bowdle TA, Ghoneim MM, et al. The incidence of awareness during anesthesia: a multicenter United States study. Anesthesia & Analgesia. 2004;99:833-839. 3. Lennmarken C, Sandin R. Neuromonitoring for awareness during surgery. Lancet. 2004;363:1747-1748. 4. Sneyd JR. Remembering awareness. British Journal of Anaesthesia. 2004;93(3):596-597. 5. Ekman A, Lindholm ML, Lennmarken C, et al. Reduction in the incidence of awareness using BIS monitoring. Acta Anaesthesiologica Scandinavica. 2004;48:20-26. 6. Myles PS, Leslie K, McNeil J, et al. Bispectral index monitoring to prevent awareness during anaesthesia: the B-Aware randomised controlled trial. Lancet. 2004;363:1757-1763.

* Sinclair E. AwarenessA personal viewpoint. Presidents Update. 2005;8(1):1-2.

[http://www.asahq.org/news/PresUpdate071105.pdf]

A P P E N D I X
Integrating BIS Monitoring into Practice
gence time and consumption of anesthetic drugs. Consistent with the BIS Range Guidelines shown in Figure A, most of these clinical investigations have titrated the primary anesthetic agent to maintain the BIS values between 45 and 60 during the maintenance phase of general anesthesia. The integration of BIS monitoring with other traditional methods of patient assessment can add important insight regarding patient status to aid in anesthesia management decisions. The interpretation of BIS information with the other elements of conventional anesthetic monitoring has been incorporated into a patient management framework as presented in Table A (Page 8) and described in detail elsewhere.* t While the two large trials discussed earlier demonstrate the substantial clinical efficacy of using a BIS-based strategy (maintaining BIS < 60) to reduce the incidence of awareness, it is important to understand some fundamental issues regarding the use of BIS monitoring. In the two awareness trials, BIS values > 60 without evidence of awareness were observed in a small percentage of anesthesia time (averaging about one minute of each hour of anesthesia). This highlights that BIS values greater than 60 may not always reflect inadequate anesthetic effect and potential for an awake patient, but may sometimes occur as the result of external artifacts, certain pharmacologic agents, or other unrelated causes (Table B). A recent review paper provides a comprehensive discussion of the spectrum of possible artifact conditions based upon isolated case reports and small series.t t It is important for clinicians to consider these factors when troubleshooting unusual BIS values. However, the large-scale trials demonstrate that despite the potential for these types of artifact-inducing conditions, reliable BIS values are obtained throughout the vast majority of clinical cases.

Because the Practice Advisory suggests a greater role for brain function monitoring as one of the modalities to assess anesthetic depth, it is important to consider the integration of this modality into overall anesthesia management. As reviewed in the Practice Advisory, randomized clinical trials have demonstrated that the adjustment of anesthetic delivery (titration) to maintain BIS values within a bracketed target range reduces emerFigure A

BIS RANGE GUIDELINES

100

Awake
Responds to normal voice

Table B

REPORTED FACTORS INFLUENCING BIS

80

BIS Index Range

Responds to loud commands or mild prodding/shaking

60

General Anesthesia
Low probability of explicit recall Unresponsive to verbal stimulus

EMG TONE AND NEUROMUSCULAR BLOCKING AGENTS MAY INFLUENCE BIS Excessive muscle tone from forehead muscles may increase BIS values, referred to as EMG artifact Administration of NMB agents will alleviate EMG artifact and may result in BIS decrease During stable anesthesia with absence of EMG artifact, NMB agents have no effect on BIS ELECTRICAL DEVICES Medical devices producing electromechanical artifact may increase BIS values Pacemakers, forced-air warmers, surgical navigation systems, endoscopic shaver devices ANESTHETIC AGENTS Ketamine administration may increase BIS values due to a unique pattern of EEG activation Halothaneat equipotent dosesresults in higher BIS values than isoflurane or sevoflurane Transient paradoxical response to increased isoflurane dose has been reported CLINICAL CONDITIONS Certain serious clinical conditions have been associated with low BIS values during the intraoperative period: Cardiac arrest, hypovolemia, cerebral ischemia Hypoglycemia, hypothermia Unusually low BIS values and awareness have been reported in some patients receiving anticonvulsant medications BIS values should be interpreted with caution in patients with neurological disorders

45

Deep Hypnotic State

20

Burst Suppression

Flat Line EEG

* Kelley SD. Monitoring Level of Consciousness during Anesthesia and Sedation. Newton MA. Aspect Medical Systems, 2003.
t tt

www.biseducation.com Dahaba AA. Different conditions that could result in the bispectral index indicating an incorrect hypnotic state. Anesthesia & Analgesia. 2005;101:765-773.

Table A

PATIENT MANAGEMENT TABLE

Physical Signs

Clinical Profile

BIS Index*

Management Strategy
Assess level of surgical stimulation Confirm delivery of hypnotics/analgesics Consider hypnotic/ analgesic dosing Consider antihypertensive administration

High value

Hypertension Tachycardia Movement Autonomic responses

Light

Desired range (e.g., BIS 45-60)

Assess level of surgical stimulation Consider analgesic dosing Consider antihypertensive administration

Low value

Consider antihypertensive administration Assess level of surgical stimulation Consider hypnotic/ analgesic dosing

High value

Assess level of surgical stimulation Consider hypnotic dosing Consider analgesic dosing

Stable hemodynamics No movement/ responses

Adequate

Desired range (e.g., BIS 45-60)

Continue observation

Low value

Consider hypnotic dosing Consider analgesic dosing

High value

Consider blood pressure support Assess for other etiologies Consider hypnotic/ analgesic dosing

Hemodynamic instability Hypotension Arrhythmia

Deep

Desired range (e.g., BIS 45-60)

Assess for other etiologies Consider blood pressure support

Low value

Consider hypnotic/ analgesic dosing Consider blood pressure support Assess for other etiologies

Strategy for intraoperative management based on integration of BIS index value with observed clinical response. Patient management should never be based upon BIS monitoring information alone.

* Potential impact of artifact should be considered when interpreting BIS values.

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