2 Benefits of depth of anaesthesia monitors

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1 Costing statement: Electroencephalography (EEG)- based depth of anaesthesia monitors Bispectral Index (BIS), E-Entropy and Narcotrend-Compact M 1 Introduction 1.1 The resource impact of the NICE diagnostics guidance on the access to depth of anaesthesia monitors for patients at higher risk of adverse outcomes during general anaesthesia will vary depending on local current practice and future procurement decisions, and should be investigated locally. The national cost impact of implementing the guidance is uncertain, since the guidance states that use of the monitors is an option under certain circumstances. The guidance recommends three technologies, the Bispectral Index (BIS) monitor, the E-Entropy monitor and the Narcotrend-Compact M monitor during any type of general anaesthesia in patients considered at higher risk of adverse outcomes. This includes patients at higher risk of unintended awareness and patients at higher risk of excessively deep anaesthesia. Currently the BIS monitor is thought to be the most widely used. 1.2 This costing statement should be read alongside the diagnostics guidance. Appendix A states the recommendations within the guidance. 2 Benefits of depth of anaesthesia monitors 2.1 EEG-based depth of anaesthesia monitors are designed to indicate the probability of consciousness with explicit recall in patients

2 receiving general anaesthesia, and to aid the tailoring of anaesthetic dose to the individual patient to avoid inadequate or excessively deep levels of anaesthesia. 2.2 Measuring a patient s response to anaesthesia is important clinically because an inadequate level of anaesthesia can result in patient awareness during surgery, which can cause post-traumatic stress disorder in some patients. Conversely, an excessively deep level of anaesthesia can result in prolonged recovery, and has been linked to an increased risk of postoperative adverse outcomes, including myocardial infarction, stroke and cognitive dysfunction in older patients. Depth of anaesthesia monitors aim to reduce the risk of adverse outcomes resulting from general anaesthesia. 3 Patient numbers affected 3.1 It is estimated that 2.4 million people received general anaesthesia in England in Approximately half of those who have a general anaesthetic also receive muscle relaxants (Depth of anaesthesia monitors (E-Entropy, BIS and Narcotrend): guidance). 3.2 Unintended awareness during surgery is a relatively uncommon event, so large studies (with a sample size of at least 10,000 patients) are needed to accurately estimate the incidence. Such studies have not been conducted in the UK. In other countries, large studies, which have all been based on adult populations, suggest that the incidence rate for awareness or recall during general anaesthesia is typically 1 2 patients per Using an average incidence of 1.5 patients per 1000 means that approximately 3,600 patients a year in the UK may experience intraoperative awareness. 3.3 There are no incidence figures available for patients receiving excessively deep anaesthesia but it is thought that the incidence of excessively deep anaesthesia could potentially exceed the

3 incidence of intraoperative awareness. This group often consists of older people and people with a high BMI. 4 Current practice in depth of anaesthesia monitoring 4.1 In current NHS clinical practice, a patient's response to anaesthesia during surgery is assessed by clinical observation of signs such as excessive tear formation (lacrimation), sweating, pupillary size and reactivity, and the use of supplementary monitoring devices. These devices include an electrocardiograph (ECG) to measure the speed and rhythm of the heart, a noninvasive blood pressure monitor, a pulse oximeter to detect the pulse and estimate the amount of oxygen in the blood, a device to measure the patient s temperature, a device to monitor end-tidal anaesthetic concentration (for inhaled anaesthesia) and provide a minimum alveolar concentration (MAC) value, a nerve stimulator (if a muscle relaxant is used), and a capnograph to monitor the inhaled and exhaled concentration of carbon dioxide. Additional monitoring equipment such as a cardiac output monitor may be used for some patients or certain types of surgery. 4.2 Expert opinion suggests that there is low use of EEG-based depth of anaesthesia monitors. Current use of BIS technology in UK operating theatres is unknown but, because most anaesthetic monitors used in the UK could be compatible with the BIS module, BIS technology could eventually be used in most UK operating theatres. At the end of March 2012, there were 3007 operating theatres in England (Department of Health May 2012). The manufacturers of E-Entropy estimate that nearly 45% of UK theatres would be ready and compatible with E-Entropy. No data are available on the use of Narcotrend in the UK. 5 Potential costs and savings

4 5.1 The costs of depth of anaesthesia monitoring consist of the capital costs associated with acquiring the monitor and recurring costs associated with sensors that are attached to the patient. The cost of the monitors varies from 4,687 for the BIS monitor to 10,285 (the midpoint of a range of prices for Narcotrend-Compact M). Sensor costs varied more widely, with costs per patient of 14.08, 8.68 and 0.56 for BIS, E-Entropy and Narcotrend-Compact M respectively (Depth of anaesthesia monitors (E-Entropy, BIS and Narcotrend): guidance). The Committee noted anecdotal evidence that the BIS monitor and sensors could be procured locally at lower costs than those given in table 1 below. 5.2 The equivalent annual cost of monitors based on the following prices of 5,352, 4,867 and 10,285 are 1,658, 1,452 and 3,185 respectively. This is based on the monitors having a useful life of 5 years, a discount rate of 3.5% and service or maintenance costs of 10 per cent of initial outlay. The consumable costs will depend on the number of patients who are seen within the year. Table 1 Costs of depth of anaesthesia modules Depth of anaesthesia model Cost of depth of anaesthesia monitor ( ) Sensor cost, per patient ( ) E-Entropy 5, Bispectral index (BIS) Vista Bispectral index (BIS) Vista bilateral 4,350 5, Narcotrend-Compact M 8,572 11, Notes 1 Based on manufacturer s price of 217 for a box of 25 sensors (1 sensor per patient). 2 Cost of the most commonly used sensor. 3 Range of prices quoted, dependent on model. 4 Based on the manufacturer s price of 0.14 per sensor (3 needed for 1-channel recording and 5 needed for 2-channel recording). Source: Shepherd J et al. (2012)

5 5.3 In general, BIS, E-Entropy and Narcotrend technologies for monitoring the depth of anaesthesia are associated with reductions in general anaesthetic consumption and decreased anaesthetic recovery times compared with standard clinical monitoring and clinical observation. However, these reductions may be considered clinically modest. 5.4 Other more long-term benefits from the use of the monitors relate to lowering the risk of impairing a patient s quality of life. Patients who experienced severe long-term psychological or psychiatric symptoms following awareness during surgery have reported that the symptoms caused a definite impairment of the quality of their lives. For example, it may limit their ability to work, and have an adverse effect on relationships with family and friends. 5.5 Adverse outcomes of excessively deep general anaesthesia include prolonged recovery, particularly in people with a high BMI. In severe cases or in at-risk patient groups (for example, older patients, patients with liver disease, and patients with poor cardiovascular function), excessively deep anaesthesia can result in haemodynamic instability and respiratory depression complications (which can be fatal without cardiorespiratory support). Inappropriately deep anaesthesia has also been linked to an increased risk of postoperative complications such as myocardial infarction and stroke in older patients. There is some evidence to suggest a link between longer term morbidity (for example, cognitive dysfunction) and mortality, and the depth of anaesthesia. 5.6 The need for additional training for staff to operate the monitors appears to vary by monitor. The Committee considered that appropriate training should be given to anaesthetists using depth of anaesthesia monitors because the monitors can involve significant changes to clinical practice to achieve clinical benefit. The skill and experience of the anaesthetist in using a depth of anaesthesia

6 monitor are therefore likely to influence the clinical effectiveness of the technique. 5.7 The manufacturer of the BIS monitor provides instructions for use with both the BIS monitor (stand-alone or module) and the BIS sensors. Additional educational resources, such as interactive simulation devices and on-line multimedia courses are available. Also one to one, small group and in house training are provided by a BIS clinical specialist, if needed. There is no restriction on the amount of training provided. The manufacturer of the E-Entropy monitor provides a 30 minute introductory training session for healthcare staff with particular attention being paid to sensor application. The manufacturer of the Narcotrend-Compact M monitor provides a 1 day introductory session for healthcare staff comprising a lecture and a demonstration of the use of the Narcotrend-Compact M monitor in the operating theatre. 5.8 The main implications for service provision will be the installation of an EEG-based depth of anaesthesia monitor, any training involved, and follow-up maintenance. Monitor installation is unlikely to be particularly disruptive, although it is important to ensure that the type of monitor (BIS, E-Entropy or Narcotrend-Compact M) used is compatible with the patient sensors and other equipment used in both the anaesthetic room and operating room. 5.9 Two of the devices BIS and E-Entropy are available as plug in modules and they connect to the main anaesthesia monitors. Narcotrend is a stand-alone monitor. As a result they are not theatre dependent. 6 Asset planning 6.1 When deciding whether to provide depth of anaesthesia monitors, service providers and commissioners may wish to consider the proportion of surgery that occurs in groups of patients who are

7 considered at higher risk of adverse outcomes from general anaesthesia including: patients who are considered at higher risk of unintended awareness during general anaesthesia patients who are considered at higher risk of excessively deep levels of anaesthesia patients receiving total intravenous anaesthesia. 7 Conclusion 7.1 The cost and potential savings of using EEG-based depth of anaesthesia monitors will need to be investigated at a local level, taking into account the long-term benefits that could be gained from their use. 8 Appendices 8.1 Appendix A The guidance states that: The use of electroencephalography (EEG)-based depth of anaesthesia monitors is recommended as an option during any type of general anaesthesia in patients considered at higher risk of adverse outcomes. This includes patients at higher risk of unintended awareness and patients at higher risk of excessively deep anaesthesia. The Bispectral Index (BIS) depth of anaesthesia monitor is therefore recommended as an option in these patients. The use of EEG-based depth of anaesthesia monitors is also recommended as an option in all patients receiving total intravenous anaesthesia. The BIS monitor is therefore recommended as an option in these patients.

8 Although there is greater uncertainty of clinical benefit for the E-Entropy, and Narcotrend-Compact M depth of anaesthesia monitors than for the BIS monitor, the Committee concluded that the E-Entropy and Narcotrend-Compact M monitors are broadly equivalent to BIS. These monitors are therefore recommended as options during any type of general anaesthesia in patients considered at higher risk of adverse outcomes. This includes patients at higher risk of unintended awareness and patients at higher risk of excessively deep anaesthesia. The E-Entropy and Narcotrend-Compact M monitors are also recommended as options in patients receiving total intravenous anaesthesia. Anaesthetists using EEG-based depth of anaesthesia monitors should have appropriate training and experience with these monitors and understand the potential limitations of their use in clinical practice. Patients who are considered at higher risk of unintended awareness during general anaesthesia include patients with high opiate or high alcohol use, patients with airway problems, and patients with previous experience of accidental awareness during surgery. The risk of unintended awareness is also raised by the use of concomitant muscle relaxants. Older patients, patients with comorbidities and those undergoing certain types of surgery are also considered at a higher risk of unintended awareness. This is because they are at greater risk of haemodynamic instability during surgery. In these patients, lower levels of anaesthetic are often used to prevent adverse effects on the cardiovascular system and these levels can be inadequate. Patients who are considered at higher risk of excessively deep levels of anaesthesia include older patients, patients with liver disease, patients with a high body mass index (BMI), and patients with poor cardiovascular function. Patients receiving total intravenous anaesthesia are not considered at higher risk of adverse outcomes from general anaesthesia than patients receiving

9 inhaled anaesthesia. The use of EEG-based depth of anaesthesia monitors has been recommended in patients receiving total intravenous anaesthesia because it is cost effective and because it is not possible to measure end-tidal anaesthetic concentration in this group. 9 References 1. Department of Health (2012) The number of operating theatres in operation in England [online] [Accessed 1 November 2012] 2. National Institute for Health and Clinical Excellence (2012) Depth of anaesthesia monitors Bispectral Index (BIS), E-Entropy and Narcotrend- Compact M. NICE diagnostics guidance [online] 3. Shepherd J, Jones J, Frampton G et al. (2012) Depth of anaesthesia monitoring (E-Entropy, Bispectral Index and Narcotrend). Technology Assessment Report commissioned by the NIHR HTA Programme on behalf of the National Institute for Health and Clinical Excellence Diagnostics Assessment Report [online] [Accessed 1 November 2012]

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