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To the Editor: Safety is a rather subjective concept, so to use the word without definition, as Clarke et al did,1 is somewhat misleading. One possible definition is that the complication rate for general practitioners is no greater than for anaesthetists in the same circumstances.
In the study by Clarke et al,1 the GPs were allocated the lower-risk cases and the anaesthetists were allocated the more difficult ones. Direct comparison was made without any adjustment for this difference. The data suggest that the GPs had similar or higher rates of adverse events or interventions despite handling lower-risk cases.
The most recent data on anaesthesia-related mortality reports 20 deaths at endoscopy from 1994–1996, with a note that this is likely to be an underestimate.2 Using the authors' denominator of 430 000 endoscopies per year, an estimated risk of anaesthesia-related death is therefore about 1 in 64 000. The risk of anaesthesia-related death for all surgery is quoted as 1 in 63 000, which implies that anaesthesia for endoscopy is of average risk. The sample size of 28 000 lacks sufficient power to make any comment on safety as regards the risk of death.
Although I applaud the clinical standards of the authors' institution and fully agree that propofol has many clinical benefits over other agents, Clarke et al do not prove safety in the use of propofol by non-anaesthetists.
Correspondence: Dr J P Clarke, Department of Anaesthesia, Flinders Medical Centre, Bedford Park, SA.
To the Editor: We read with interest the article by Clarke et al1 and the accompanying editorial by Knoblanche,2 and are concerned that they may be interpreted as endorsing the use of the anaesthetic agent propofol in sedation techniques by personnel inadequately trained in anaesthetic techniques.
Cases reported to the Victorian Consultative Council on Anaesthetic Mortality and Morbidity confirm the risk of serious morbidity and mortality associated with these procedures. Our report for the triennium 1997–1999 will include two deaths at endoscopy where a non-specialist administered the sedation or anaesthetic. In both of these cases, propofol was used.
The circumstances described by Clarke et al are exceptional. They combine a scrupulous adherence to the professional guidelines3 and a significant involvement by the administration of the endoscopy centre in the selection, education and on-going training of the general practitioner sedationists. They include incident reporting of adverse events and non-standard treatments as part of a quality assurance program. Although not specified, there is also, presumably, access to high-quality back-up. This level of attention to detail is by no means universal.
We would like to endorse several observations made in the articles:
For a procedure to be considered sedation, it is imperative that the drugs used are not intended to, and do not, cause loss of consciousness or the loss of protective reflexes or spontaneous ventilation; by definition, this would be anaesthesia.
Proper selection and careful medical assessment of patients is very important, and training must enable the identification of patients at higher risk.
People administering sedation must have knowledge of the pharmacology of the agents being administered and modifications necessary because of concurrent therapeutic regimens or disease states. They must also ensure adequate intraprocedure monitoring is provided, that they have experience in interpretation of abnormal indices, and that they can manage any complications arising from the procedure, with particular emphasis on airway management and cardiovascular resuscitation.
There may be benefits with the use of propofol, but the guidelines, designed for patient safety, clearly state: "Intravenous anaesthetic agents such as propofol must only be used by an anaesthetist."3
Technological advances in non-invasive and minimally invasive procedures have led to an explosion in demand for sedation of increasing complexity in areas removed from the traditional operating room environment. Consequently, demand for sedation by non-anaesthetists is likely to grow. It is important that the standard of care and patient safety be maintained in all these circumstances.
The concern is not whether the practitioner administering the sedation is a general practitioner or a specialist, but whether he or she has the training and skills necessary to function as an anaesthetist. The terms "general practitioner sedationist" and "non-anaesthetist" might give an impression of diminished risk, which is not supported by the experience of this committee.
The Victorian Consultative Council on Anaesthetic Mortality and Morbidity, Melbourne, VIC.
Patricia Mackay, Chairman; Patrick J Hughes, Australian Society of Anaesthetists Nominated Representative.Correspondence: Dr P Mackay, The Victorian Consultative Council on Anaesthetic Mortality and Morbidity, GPO Box 4923, Melbourne, VIC 3001.
In reply: We thank Clarke and Mackay and Hughes for their interest and comments. We accept that a sample larger than the 28 000 endoscopies we reported1 would be required to establish the true incidence of death or other catastrophic complications of our sedation service. As the mortality rate is expected to be so low, it would take many years to achieve an adequate sample size. It is even difficult to determine the mortality from endoscopy in Australia, as quantifying all the endoscopies performed is problematic, and the Royal Australian and New Zealand College of Anaesthetists believes that not all deaths occurring from endoscopy are reported to anaesthetic mortality committees.2
It is essential that any sedation service is carefully planned, and that all doctors providing sedation receive adequate training and follow the protocols and guidelines of the endoscopy centre. However, we challenge the opinion that only anaesthetists should use propofol. We have not been able to find any clinical safety studies that demonstrate that only anaesthetists are able to use propofol safely. We believe the results of our study show that, when propofol is used in the manner described in the article, the rate of ventilatory and other complications is low (but clearly not zero).
There is no reason to believe that the propofol component of the sedation regimen increased the rate of ventilatory problems. Indeed, it might, through its short duration of action, minimise such problems. To arbitrarily exclude the use of propofol by appropriately trained GP sedationists would deny many patients the manifest benefits of this drug. Importantly, our GPs have been shown capable of successfully managing the problems of airway obstruction and apnoea that were encountered — whatever the cause. We agree with Mackay and Hughes that the GP sedationists need to have the anaesthesia skills necessary to maintain patient ventilation, as well as an excellent understanding of all the drugs they use.
Anaesthetists play a major role in improving safety standards in the provision of sedation for endoscopy through codifying the standards required,3 assisting the training of staff, and delivering sedation services to high-risk patients. But many patients can be successfully sedated without a specialist anaesthetist being present. We argue there is no evidence that these patients should receive a suboptimal regimen. Most specialist anaesthetists have a more valuable role to fill than providing sedation for straightforward endoscopies.
Mugga Wara & Brindabella Endoscopy Centres, Brindabella Specialist Centre, Canberra, ACT.
Anthony C Clarke, FRCP, FRACP, Gastroenterologist; Lybus C Hillman, MD, FRACP, Gastroenterologist.Correspondence: Dr A C Clarke, Mugga Wara & Brindabella Endoscopy Centres, Brindabella Specialist Centre, 7/5 Dann Close, Garran, Canberra, ACT 2605. tony_clarkeATbigpond.com
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©The Medical Journal of Australia 2002 www.mja.com.au PRINT ISSN: 0025-729X ONLINE ISSN: 1326-5377