Sedations in diagnostic and/or therapeutic procedures: Quality and safety recommendations

Cabadas Avion, R.; Rabanal Llevot, J.M.; Gil de Bernabé, M.À.; Guasch Arévalo, E.; Aldecoa Álvarez-Santullano, C.; Echevarría Moreno, M.
doi:10.1016/j.redare.2018.09.004
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it is important to remember that the presence of an anaesthesiologist to oversee these techniques is a means of guaranteeing patient safety and improving the conditions in which the procedures are carried out by the different specialists involved&#46;</p><p id="par0010" class="elsevierStylePara elsevierViewall">Recently&#44; Arnal et al&#46;&#44;<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">2</span></a> prompted by the different sedation techniques is used in Spain&#44; gathered data from the Spanish Anaesthesia and Critical Care Incident Reporting System to create a patient-safety centred consensus document that was published in the <span class="elsevierStyleSmallCaps">Spanish Journal of Anesthesiology</span>&#46; The recommendations were reviewed by a large expert working group&#44; and has formed the basis for this study in which the Spanish Society of Anaesthesiology and Critical Care &#40;SEDAR&#41; outlines the fundamental aspects to be considered when administering sedation outside the operating room&#46;</p><p id="par0015" class="elsevierStylePara elsevierViewall">We at SEDAR consider is essential to protocolise the administration of sedation in Spanish hospitals to ensure that it is performed in accordance with scientific evidence and international recommendations<a class="elsevierStyleCrossRefs" href="#bib0100"><span class="elsevierStyleSup">3&#44;4</span></a> &#40;Declaration of Helsinki&#44;<a class="elsevierStyleCrossRef" href="#bib0110"><span class="elsevierStyleSup">5</span></a> Joint Commission&#44;<a class="elsevierStyleCrossRef" href="#bib0115"><span class="elsevierStyleSup">6</span></a> Food and Drug Administration<a class="elsevierStyleCrossRef" href="#bib0120"><span class="elsevierStyleSup">7</span></a>&#41;&#46; For this purpose&#44; we created a working group to review the available scientific literature and international recommendations and draft a protocol defining the most relevant aspects of this technique in order to maximise the effectiveness&#44; efficiency&#44; quality and safety sedation procedures&#46; This consensus document has been approved by the Spanish Society of Anesthesiology&#44; Critical Care and Pain Management&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">The Joint Commission<a class="elsevierStyleCrossRef" href="#bib0115"><span class="elsevierStyleSup">6</span></a> is an independent&#44; non-profit organisation that accredits health care organisations and programmes&#46; Its mission is to continuously improve health care by evaluating health care organisations and inspiring them to excel in providing safe and effective care&#46; The Joint Commission assigns anaesthesia departments the role of organising the administration of moderate and deep sedation through the ASC&#46;2 standard&#44; which states that &#8220;Anaesthesia services &#40;including moderate and deep sedation&#41; are under the direction of one or more qualified individuals&#8221;&#46; In the Joint Commission&#39;s standards&#44; sedation is described in a separate subsection of the &#8220;anaesthesia and surgical care&#8221; set of standards&#44; given the risks to patient safety&#46; In section 54&#46;A of its ASC&#46;3 standard&#44; the Joint Commission requires that &#8220;Policies and procedures guide the care of patients undergoing moderate and deep sedation&#8221;&#46; According to this standard&#44; &#8220;sedation&#44; particularly moderate and deep sedation&#44; represents risks for patients and therefore must be administered using clear definitions&#44; policies and procedures&#46; A patient will progress from one level of sedation to another depending to the drugs administered&#44; the route of administration and the dose&#46; Important elements to consider include the patient&#39;s ability to maintain protective reflexes&#44; an independent and continuous airway&#44; and the response to physical stimuli or verbal commands&#46;&#8221;</p><p id="par0025" class="elsevierStylePara elsevierViewall">According to Monedero et al&#46;&#44;<a class="elsevierStyleCrossRef" href="#bib0125"><span class="elsevierStyleSup">8</span></a> the Declaration of Helsinki&#44;<a class="elsevierStyleCrossRef" href="#bib0110"><span class="elsevierStyleSup">5</span></a> a consensus document jointly drawn up by the European Society of Anaesthesiology and the European Board of Anaesthesiology and presented at the Helsinki European Congress in 2010&#44; &#8220;represents the opinion shared in Europe on the feasible and valuable measures that can improve the safety of the surgical patient&#44; and recommends the practical steps that every anaesthesiologist and anaesthesiology service should include in their medical practice&#44; if they have not already done so&#8221;&#46; The Declaration makes specific reference to the field of sedation&#58; &#8220;All institutions providing sedation to patients must comply with anaesthesiology recognised sedation standards for safe practice&#8221;&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall">In this document&#44; SEDAR has established the basic sedation-related activities in anaesthesiology departments&#44; and calls on healthcare institutions to use it as a basis from drawing up sedation protocols&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">We define the different phases of the sedation process in order to establish the basic parameters that must be met when protocolising sedation in each hospital&#46;</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Definition of sedation</span><p id="par0040" class="elsevierStylePara elsevierViewall">Sedation consists of administering a drug that will allow the patient to tolerate a diagnostic&#47;therapeutic procedure while maintaining cardiorespiratory function&#46; The impairment&#47;alteration of the level of consciousness &#40;to varying degrees&#41; is a characteristic of this technique&#46;</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Pre-sedation evaluation</span><p id="par0045" class="elsevierStylePara elsevierViewall">There is broad consensus among experts on the need to evaluate the patient prior to administering sedation&#44; to obtain specific informed consent&#44; and on the need for prior preparation&#44; including fasting and the management of chronic medication&#46; This pre-sedation evaluation must be performed by the team that is responsible for sedation&#46;<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">2</span></a></p><p id="par0050" class="elsevierStylePara elsevierViewall">The patient&#39;s physiological status must be evaluated before administering sedation&#44; since the presence of concomitant diseases can increase the risk of complications during sedation&#46;<a class="elsevierStyleCrossRefs" href="#bib0130"><span class="elsevierStyleSup">9&#44;10</span></a> Therefore&#44; an adequate pre-procedure evaluation will reduce the likelihood of adverse events and the risks inherent to these outcomes&#46; If necessary&#44; additional tests should be requested&#44; depending on the patient&#39;s concomitant disease or the results of the endoscopic examination&#46; For this purpose&#44; the guidelines for requesting complementary tests in major ambulatory surgery &#40;MAS&#41; recently approved by the Spanish Society of Anaesthesiology can be used&#46;<a class="elsevierStyleCrossRef" href="#bib0140"><span class="elsevierStyleSup">11</span></a></p><p id="par0055" class="elsevierStylePara elsevierViewall">The pre-anaesthesia evaluation for simple procedures &#40;gastroscopy&#44; colonoscopy &#8211; including colorectal cancer screening colonoscopy&#41; can consist of a general health status test&#44; such as the one attached here as Appendix A&#46; If the patient is classified ASA III or IV&#44; or will undergo a lengthy&#44; complex procedures &#40;for example&#44; endoscopic retrograde cholangiopancreatography&#41;&#44; the standard anaesthesia workup used in any surgical procedure should be performed&#46;</p></span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Informed consent</span><p id="par0060" class="elsevierStylePara elsevierViewall">All patients must sign 2 informed consent forms&#58;<ul class="elsevierStyleList" id="lis0005"><li class="elsevierStyleListItem" id="lsti0005"><span class="elsevierStyleLabel">&#8226;</span><p id="par0065" class="elsevierStylePara elsevierViewall">A form describing the type of diagnostic-therapeutic procedure and the risks involved&#46;</p></li><li class="elsevierStyleListItem" id="lsti0010"><span class="elsevierStyleLabel">&#8226;</span><p id="par0070" class="elsevierStylePara elsevierViewall">A form describing the type of sedation&#47;general anaesthesia to be administered and the risks involved&#46; The form must clearly state who administers the sedation &#40;clearly specifying whether it is an anaesthesiologist&#41;&#46;</p></li><li class="elsevierStyleListItem" id="lsti0015"><span class="elsevierStyleLabel">&#8226;</span><p id="par0075" class="elsevierStylePara elsevierViewall">Each hospital must draw up informed consent forms that comply with regional and national regulations&#46;</p></li></ul></p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Levels of sedation</span><p id="par0080" class="elsevierStylePara elsevierViewall">Before starting sedation&#44; the target level for the particular endoscopic procedure must be established&#46;</p><p id="par0085" class="elsevierStylePara elsevierViewall">The depth of sedation will vary&#44; and in this respect SEDAR recommends using the European Society of Anaesthesiology classification&#46;<a class="elsevierStyleCrossRef" href="#bib0145"><span class="elsevierStyleSup">12</span></a><ul class="elsevierStyleList" id="lis0010"><li class="elsevierStyleListItem" id="lsti0020"><span class="elsevierStyleLabel">&#8226;</span><p id="par0090" class="elsevierStylePara elsevierViewall">Sedation level 1&#58; Fully awake&#46;</p></li><li class="elsevierStyleListItem" id="lsti0025"><span class="elsevierStyleLabel">&#8226;</span><p id="par0095" class="elsevierStylePara elsevierViewall">Sedation level 2&#58; Drowsy&#46;</p></li><li class="elsevierStyleListItem" id="lsti0030"><span class="elsevierStyleLabel">&#8226;</span><p id="par0100" class="elsevierStylePara elsevierViewall">Sedation level 3&#58; Apparently asleep but rousable by normal speech&#46;</p></li><li class="elsevierStyleListItem" id="lsti0035"><span class="elsevierStyleLabel">&#8226;</span><p id="par0105" class="elsevierStylePara elsevierViewall">Sedation level 4&#58; Apparently asleep but responding to a standardised physical stimulus&#46;</p></li><li class="elsevierStyleListItem" id="lsti0040"><span class="elsevierStyleLabel">&#8226;</span><p id="par0110" class="elsevierStylePara elsevierViewall">Sedation level 5&#58; Asleep&#44; but not responding to physical stimuli &#40;comatose&#41;&#46; Increased risk of respiratory and cardiovascular depression&#46;</p></li></ul></p><p id="par0115" class="elsevierStylePara elsevierViewall">This scale is used in some studies because it is a quick and easy guide to monitoring sedation levels&#46;<a class="elsevierStyleCrossRefs" href="#bib0150"><span class="elsevierStyleSup">13&#44;14</span></a></p><p id="par0120" class="elsevierStylePara elsevierViewall">We consider it essential to evaluate and continuously monitor the patient&#39;s level of clinical sedation&#44; either as a therapeutic objective or as an undesirable effect of the drugs administered&#46; The level of sedation should be monitored continuously and recorded&#46;</p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Drugs</span><p id="par0125" class="elsevierStylePara elsevierViewall">A discussion of the wide range of sedative or aesthetic drugs available is beyond the scope of this document&#46; Good understanding of the management and side effects associated with each drug is essential&#44; and the clinician must have the skills needed to resolve any complications that may arise&#46;</p><p id="par0130" class="elsevierStylePara elsevierViewall">However&#44; it is important to mention that only anaesthesiologists may administer propofol&#44; and it must be used as indicated in the package insert<a class="elsevierStyleCrossRef" href="#bib0160"><span class="elsevierStyleSup">15</span></a>&#58; &#8220;Propofol &#40;10<span class="elsevierStyleHsp" style=""></span>mg&#47;ml&#41; should be administered only in hospitals or adequately equipped day therapy units by physicians trained in the administration of general anaesthesia or management in an intensive care unit&#8221;&#46; This is also endorsed by the Food and Drug Administration&#44;<a class="elsevierStyleCrossRef" href="#bib0120"><span class="elsevierStyleSup">7</span></a> which has issued 2 alerts banning the use of propofol by non-anaesthesiologists&#46; Therefore&#44; use of propofol requires the presence of an anaesthesiologist in the diagnostic and&#47;or therapeutic procedures room&#46;</p><p id="par0135" class="elsevierStylePara elsevierViewall">We also recommend that the use of other analgesics and&#47;or sedatives by other physicians in any context must be comply with professional rules of conduct&#44; and the clinician involved must be prepared to substantiate his or her competence during any civil or criminal proceedings brought for sedation-related injury&#46;</p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0030">Patient selection</span><p id="par0140" class="elsevierStylePara elsevierViewall">Each hospital should define its patient selection circuit&#44; ensuring that each patient receives an adequate pre-procedure assessment based on their concomitant diseases and the scheduled procedure&#46;</p><p id="par0145" class="elsevierStylePara elsevierViewall">The doctor ordering the procedure is responsible for indicating the potential need for sedation&#46;</p><p id="par0150" class="elsevierStylePara elsevierViewall">We recommend that each hospital draw up a specific sedation care protocol that is managed by the anaesthesia service&#44; but that includes all the departments involved &#40;multidisciplinary&#41; and is approved by the hospital management&#46;</p></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Staff requirements and functions</span><p id="par0155" class="elsevierStylePara elsevierViewall">Patients receiving sedation should be under the care and supervision of trained health professionals&#46; An anaesthesiologist is trained in the administration of sedation&#44; and the hospital&#39;s management board should ensure that the anaesthesia service is equipped with the trained clinicians&#44; nurses&#44; and material resources needed to fulfil these responsibilities&#46;</p><p id="par0160" class="elsevierStylePara elsevierViewall">Nurse anaesthesiologists can and should play an important role in providing care and monitoring patients receiving sedation&#44; always under the direct supervision of the attending anaesthesiologist&#46;</p><p id="par0165" class="elsevierStylePara elsevierViewall">SEDAR recommendations for any type of sedation are&#58;<ul class="elsevierStyleList" id="lis0015"><li class="elsevierStyleListItem" id="lsti0045"><span class="elsevierStyleLabel">&#8226;</span><p id="par0170" class="elsevierStylePara elsevierViewall">Follow the standards for safe sedation established in the Declaration of Helsinki&#46; This means that anaesthesia departments must supervise all sedation procedures &#40;also established by the Joint Commission&#41;&#46;</p></li><li class="elsevierStyleListItem" id="lsti0050"><span class="elsevierStyleLabel">&#8226;</span><p id="par0175" class="elsevierStylePara elsevierViewall">Non-anaesthesiologists should only administer sedation up to level 3&#44; since higher levels are associated with an increased risk of complications&#46;<a class="elsevierStyleCrossRef" href="#bib0165"><span class="elsevierStyleSup">16</span></a></p></li><li class="elsevierStyleListItem" id="lsti0055"><span class="elsevierStyleLabel">&#8226;</span><p id="par0180" class="elsevierStylePara elsevierViewall">An anaesthesiologist must be available to immediately treat any complications that may arise&#46;</p></li><li class="elsevierStyleListItem" id="lsti0060"><span class="elsevierStyleLabel">&#8226;</span><p id="par0185" class="elsevierStylePara elsevierViewall">We strongly recommended that the anaesthesiology service and the service responsible for the procedure should jointly protocolise the drugs and maximum doses to be used &#40;always avoiding propofol&#41;&#46;</p></li></ul></p><p id="par0190" class="elsevierStylePara elsevierViewall">As anaesthesiology departments are responsible for organising sedation in all invasive surgical procedures&#44; each hospital must provide sufficient human resources to guarantee patient safety and quality of care by drawing up the protocols required for each case&#46;</p><p id="par0195" class="elsevierStylePara elsevierViewall">Clinicians involved in sedation procedures should avoid all risk practices that compromise patient safety&#46; The most common such practice involves the same clinician performing both the procedure and the sedation&#46;</p></span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">Facilities and equipment</span><p id="par0200" class="elsevierStylePara elsevierViewall">Diagnostic and&#47;or therapeutic procedures are usually performed in endoscopy and&#47;or radiology rooms &#40;endoscopic retrograde cholangiopancreatography&#41;&#44; although they are occasionally performed in other areas &#40;emergency room&#44; intensive care unit&#41;&#46; The rooms where these procedures are performed must have the resources needed to guarantee patient safety&#58;<ul class="elsevierStyleList" id="lis0020"><li class="elsevierStyleListItem" id="lsti0065"><span class="elsevierStyleLabel">-</span><p id="par0205" class="elsevierStylePara elsevierViewall">They must be large enough to accommodate all the necessary human and material resources&#46;</p></li><li class="elsevierStyleListItem" id="lsti0070"><span class="elsevierStyleLabel">-</span><p id="par0210" class="elsevierStylePara elsevierViewall">We recommend providing a table that allows the patient to be placed in a Trendelenburg position&#46;</p></li><li class="elsevierStyleListItem" id="lsti0075"><span class="elsevierStyleLabel">-</span><p id="par0215" class="elsevierStylePara elsevierViewall">It is advisable to have an anaesthetic machine with its corresponding monitoring equipment in each endoscopy room&#46;</p></li><li class="elsevierStyleListItem" id="lsti0080"><span class="elsevierStyleLabel">-</span><p id="par0220" class="elsevierStylePara elsevierViewall">Monitoring should include non-invasive blood pressure&#44; ECG&#44; and blood oxygen&#44; as a minimum&#46;</p></li><li class="elsevierStyleListItem" id="lsti0085"><span class="elsevierStyleLabel">-</span><p id="par0225" class="elsevierStylePara elsevierViewall">It is advisable to provide a capnograph&#46; This is particularly important in high-risk patients undergoing very lengthy procedures&#46;</p></li><li class="elsevierStyleListItem" id="lsti0090"><span class="elsevierStyleLabel">-</span><p id="par0230" class="elsevierStylePara elsevierViewall">It is essential to provide airway management devices &#40;laryngoscope&#44; tracheal tubes&#44; masks&#44; etc&#46;&#41;&#44; aspiration systems&#44; intravenous catheters&#44; drips&#44; and a &#8220;crash trolley&#8221; equipped with the drugs necessary for any type of sedation&#44; and the drugs and equipment necessary for cardiopulmonary resuscitation&#46;</p></li></ul></p></span><span id="sec0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Post-procedure monitoring</span><p id="par0235" class="elsevierStylePara elsevierViewall">After completion of the procedure&#44; the patient should be transferred to a recovery room&#44; where they can be monitored until transfer to the ward&#44; or until discharge home in ambulatory procedures&#44; according to hospital protocols&#46;</p></span><span id="sec0050" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Documentation requirements</span><p id="par0240" class="elsevierStylePara elsevierViewall">The inter-procedure anaesthesia report&#44; and the post-procedure clinical record should be completed according to the standard protocols in place in each hospital&#46;</p></span><span id="sec0055" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0055">Discharge criteria</span><p id="par0245" class="elsevierStylePara elsevierViewall">Diagnostic&#47;therapeutic procedures involving sedation can be performed on an outpatient or in-patient basis&#46; The criteria for hospital discharge must be correctly protocolised&#46; It is advisable to use a scoring system to determine the appropriate time of hospital discharge &#40;the scales usually used in outpatient surgery are valid<a class="elsevierStyleCrossRef" href="#bib0170"><span class="elsevierStyleSup">17</span></a>&#41;&#46;</p></span><span id="sec0060" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0060">Resources</span><p id="par0250" class="elsevierStylePara elsevierViewall">Anaesthesiology departments should organise their human and material resources in order to meet the objectives set out in this document&#46; The different regional healthcare authorities and hospital management boards must&#44; for their part&#44; provide all the human or material resources needed to guarantee the efficacy&#44; efficiency&#44; quality and safety targets set out in this document&#46;</p><p id="par0255" class="elsevierStylePara elsevierViewall">These recommendations are&#44; of course&#44; dynamic and may change to keep pace with scientific and technical advances and&#47;or changes in the services provided by each healthcare provider&#46;</p></span><span id="sec0065" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0065">Zero risk sedation project</span><p id="par0260" class="elsevierStylePara elsevierViewall">SEDAR supports the creation of a national programme to reduce the risk of sedation outside the operating room&#46; The second stage will involve developing the content of this programme and the corresponding monitoring indicators&#46;</p></span><span id="sec0070" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0070">Conflicts of interest</span><p id="par0265" class="elsevierStylePara elsevierViewall">The authors declare that they have no conflicts of interest&#46;</p></span></span>"
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        "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as&#58; Cabadas Avion R&#44; Rabanal Llevot JM&#44; Gil de Bernab&#233; M&#192;&#44; Guasch Ar&#233;valo E&#44; Aldecoa &#193;lvarez-Santullano C&#44; Echevarr&#237;a Moreno M&#46; Sedaciones en procedimientos diagn&#243;sticos y&#47;o terap&#233;uticos&#58; recomendaciones de calidad y seguridad&#46; Rev Esp Anestesiol Reanim&#46; 2018&#59;65&#58;520&#8211;524&#46;</p>"
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