Sedations: Safety, competency, efficiency

Alvarez Escudero, J.; Rabanal LLevot, J.M.
doi:10.1016/j.redare.2018.07.003
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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleDisplayedQuote" id="dsq0005"><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">&#8220;<span class="elsevierStyleItalic">You&#8217;ve made your bed&#44; now lie in it</span>&#8221;</p><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall"><span class="elsevierStyleItalic">Popular saying</span></p></span></p><p id="par0010" class="elsevierStylePara elsevierViewall">The need to tailor sedation to the requirements of each procedure not only benefits the diagnostic or therapeutic technique used&#44; but is also now mandatory in our informed 21st century society&#46;</p><p id="par0015" class="elsevierStylePara elsevierViewall">This has led to a sharp increase in the use of &#8220;nonoperating room anaesthesia &#40;sedation&#41;&#8221; in recent years&#44; to such an extent that anaesthesiology departments in major hospitals now devote 15&#8211;20&#37; of their human resources to this technique&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">However&#44; the introduction of colorectal cancer screening programmes in the last 5 years &#40;with indisputable health and economic benefits&#41;&#44; together with the advent of new endoscopic procedures and techniques&#44; have placed a considerable burden on anaesthesiology and gastroenterology departments&#44; in some cases undermining their capacity to provide quality care when needed&#46; This&#44; in turn&#44; has prompted organisational changes and the reassignment of duties and responsibilities involving the administration of sedation and the sedative drugs used&#46;<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">1</span></a></p><p id="par0025" class="elsevierStylePara elsevierViewall">Benzodiazepines&#44; either alone or in combination with opioids&#44; have been and continue to be the agents most frequently used for non-anaesthesiologist sedation&#46; However&#44; the addition of propofol &#40;with or without opioids&#41; to the pharmacological arsenal has marked a turning point in the quality&#44; safety and efficacy of sedation&#46; The pharmacokinetic characteristics of propofol make it the ideal drug for sedation in gastrointestinal procedures&#46; However&#44; its narrow therapeutic window can cause deep sedation with haemodynamic and respiratory depression that&#44; unlike benzodiazepines and opiates&#44; cannot be pharmacologically reversed&#46; This has sparked considerable controversy about who should be responsible for the use of propofol in gastrointestinal endoscopy and for the complications arising from its administration&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall">Despite the lack of consensus among scientific societies regarding the use of sedatives during gastrointestinal endoscopy&#44; propofol is increasing used in this context&#44; often administered directly or under supervision by the endoscopists themselves and&#47;or trained nurses&#44; without the presence of other specialists&#46;<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">2</span></a></p><p id="par0035" class="elsevierStylePara elsevierViewall">According to the package insert&#44; propofol &#8220;must only be administered in hospitals or adequately equipped day therapy units by physicians trained in anaesthesia or in the care of patients in intensive care&#8221;&#46; This&#44; therefore&#44; should settle the question of who is responsible for sedation&#58; the specialist in anaesthesiology and critical care&#46;</p><p id="par0040" class="elsevierStylePara elsevierViewall">However&#44; the unavailability of an anaesthesiologist&#44; poor leadership&#44; lack of communication&#44; intransigence&#44; cost&#44; lack of institutional support&#44; or a combination of all these factors&#44; coupled with scientific evidence from studies performed mainly in countries such as the United States &#40;with its unique health system&#41;&#44; have led some to question whether the presence of an anaesthesiologist is really required during propofol administration&#46; For example&#44; the international literature abounds with studies reporting thousands or tens of thousands of cases where propofol is administered directly by the endoscopist or by the nurse under their supervision&#44; arguing that the procedure is safe and follows the &#8220;recommendations&#8221; in the guidelines of various American or European gastroenterology societies&#46;<a class="elsevierStyleCrossRefs" href="#bib0080"><span class="elsevierStyleSup">2&#8211;5</span></a></p><p id="par0045" class="elsevierStylePara elsevierViewall">It is not the purpose of this editorial to analyse the existing evidence in the literature&#44; which includes methodologically sound studies in high impact journals&#44; and others&#44; less credible&#44; reports that should never have been published&#44; given their methodological failings&#46; The difficulty in finding homogeneous groups &#40;age&#44; ASA risk&#44; dose of propofol&#44; bolus administration or perfusion&#44; type of procedure&#44; definition of complications&#44; professional competence&#44; etc&#46;&#41; has perpetuated the debate on the safety non-anaesthesiologist administered propofol&#46; By way of example&#44; <a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a> compares the data collected in an Australian study in 2132 sedations with a Spanish study in 2072 sedations&#44; both performed by anaesthesiologists&#46; The proportion of ASA<span class="elsevierStyleHsp" style=""></span>&#8805;<span class="elsevierStyleHsp" style=""></span>3 patients is similar in both studies&#44; but the proportion of scheduled&#47;emergency endoscopies&#44; propofol dose&#44; the definition or incidence of complications varies significantly&#46; If this is the case when comparing studies in anaesthesiologist-administered propofol&#44; it is not surprising that studies comparing anaesthesiologist-administered and endoscopist-administered propofol are plagued with bias and methodological errors&#46;<a class="elsevierStyleCrossRefs" href="#bib0100"><span class="elsevierStyleSup">6&#8211;9</span></a></p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0050" class="elsevierStylePara elsevierViewall">As we all know&#44; the organisation of sedation in endoscopy varies widely among Spanish hospitals&#58; direct or indirect endoscopist-administered sedation &#40;with or without a dedicated sedation nurse&#41;&#44; total sedation administered by anaesthesiologists&#44; partial sedation &#40;at-risk patients&#44; complex examinations&#41; administered by anaesthesiologists&#44; sedation administered by &#8220;anaesthesia teams&#8221; that includes a trained sedation nurse &#40;for monitoring and care&#41; where the anaesthesiologist supervises several rooms&#44; sedation performed by specialists in intensive medicine&#44; sedation administered by endoscopists with an intensivist available on call&#44; and any combination of the above&#44; not to mention the different presedation&#44; monitoring or surveillance criteria and post-procedural discharge&#46;</p><p id="par0055" class="elsevierStylePara elsevierViewall">The debate surrounding the package insert is sterile&#46; According to the FDA&#44; 21&#37; of all medicines in the US are used off-label &#8211; a percentage similar to that found in Spain&#46; The off-label use of drugs is regulated by Royal Decree 1015&#47;2009&#44; and conflicts of competence between specialists are regulated by the provisions of the Central Commission of Deontology of the Spanish Medical Association&#46;<a class="elsevierStyleCrossRef" href="#bib0120"><span class="elsevierStyleSup">10</span></a></p><p id="par0060" class="elsevierStylePara elsevierViewall">The debate&#44; therefore&#44; should revolve around safety &#8211; on guaranteeing patient safety irrespective of the drug administered and the administering clinician&#46; This&#44; as mentioned above&#44; has given rise to multiple clinical guidelines on sedation published by different organisations and scientific societies involved in gastroenterology&#44; endoscopy&#44; and anaesthesiology both in the United States and in Europe&#46;</p><p id="par0065" class="elsevierStylePara elsevierViewall">In 2007&#44; the European Board of Anaesthesiology of the European Union of Medical Specialists published guidelines for &#8220;sedation and analgesia by non-anaesthesiologists&#8221;&#44; thus providing a reference framework at a time when anaesthesiologists were in high demand in the European Union&#46; Following this&#44; in 2010&#44; the European Gastroenterology Society&#44; the European Society of Gastrointestinal Endoscopy&#44; and the European Society of Anaesthesiology &#40;ESA&#41; published new guidelines for sedation including the use of propofol by non-anaesthesiologists&#46; Most European anaesthesiology societies either expressed their concern about these recommendations or rejected them outright&#44; and in the ESA meeting in Amsterdam in 2011 they were withdrawn by majority vote&#46;<a class="elsevierStyleCrossRef" href="#bib0125"><span class="elsevierStyleSup">11</span></a></p><p id="par0070" class="elsevierStylePara elsevierViewall">Recently&#44; the ESA&#47;EBA&#44; aware of the heterogeneity of sedation practices in Europe&#44; published new evidence-based guidelines aimed at driving through changes that will guarantee the highest levels of safety in sedation&#46; These guidelines are based on the following principles&#58; &#40;a&#41; the staff involved in administering sedation must be trained and have the skills and knowledge &#40;pharmacology&#44; monitoring&#41; needed for safe sedation&#44; as well as the skills needed to treat sedation-related complications&#59; &#40;b&#41; the professional in charge of sedation will perform this task exclusively&#46; This is crucial&#44; as no monitoring can substitute observation&#44; capacity for anticipation and human analysis&#59; &#40;c&#41; the organisation must ensure that the location of sedation rooms and their human and material resources are adequate to allow resuscitation teams to work quickly to restore vital functions&#59; and &#40;d&#41; in the case of high-risk patients or complex procedures&#44; sedation should be administered by an anaesthesiologist&#46; The guidelines do not consider which drugs should be used and which should be avoided by each type of medical professional administering sedation&#44; and only emphasise that the patient must be told who will administer sedation&#44; and their level of qualification&#46;<a class="elsevierStyleCrossRef" href="#bib0130"><span class="elsevierStyleSup">12</span></a></p><p id="par0075" class="elsevierStylePara elsevierViewall">SEDAR has also created a working group to develop its guidelines on sedation&#44; approved by the management body&#46; These recommendations can be downloaded from the SEDAR website and have been published in this issue of REDAR&#46; The document is based on the principle that any guideline or recommendation must essentially safeguard patient safety while being flexible enough to adapt to the different organisational models found in Spanish hospitals&#46;<a class="elsevierStyleCrossRefs" href="#bib0135"><span class="elsevierStyleSup">13&#44;14</span></a></p><p id="par0080" class="elsevierStylePara elsevierViewall">We believe that anaesthesiology services should organise the administration of sedation in different hospital settings by drawing up protocols&#44; coordinating with the different services and creating anaesthesia teams along the lines of existing European models&#46;</p><p id="par0085" class="elsevierStylePara elsevierViewall">As a scientific society&#44; SEDAR should be willing to engage in open&#44; sincere dialogue with our colleagues from different societies&#44; particularly the Spanish Society of Digestive Pathology&#46; Agreement will only come from a mutual understanding and a willingness to pool experience&#44; and this will undoubtedly benefit both our patients and the health system as a whole&#46;</p></span>"
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                  \t\t\t\t</th><th class="td" title="table-head  " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">Leslie et al&#46;<a class="elsevierStyleCrossRef" href="#bib0115"><span class="elsevierStyleSup">9</span></a><br><span class="elsevierStyleItalic">n</span>&#58; 2132&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">4&#46;43&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">SAO&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">2&#46;4&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">7&#46;67&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">ASA<span class="elsevierStyleHsp" style=""></span>&#8805;<span class="elsevierStyleHsp" style=""></span>III&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">42&#46;2&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">43&#46;68&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Propofol dose &#40;mg&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">200 &#40;100&#8211;300&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">70 &#40;40&#8211;130&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Exitus&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">1&#46;2&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&#46;5&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr></tbody></table>
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          "en" => "<p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">Comparison of data from Leslie et al&#46; and Cavadas et al&#46; Complications arising from anaesthesiologist-administered propofol sedation in gastrointestinal endoscopy&#46;</p>"
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