The demand for sedation outside of the operating room for diagnostic or therapeutic procedures

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Focused Issue of This Month 진정요법 http://dx.doi.org/10.5124/jkma.2013.56.4.264 pissn: 1975-8456 eissn: 2093-5951 http://jkma.org 진정요법의현황 박철수 * 가톨릭대학교의과대학서울성모병원마취통증의학과 Chul Soo Park, MD* Department of Anesthesiology and Pain Medicine, Seoul St. Mary s Hospital, The Catholic University of Korea, College of Medicine, Seoul, Korea *Corresponding author: Chul Soo Park, E-mail: p6c8s17@catholic.ac.kr Received December 12, 2012 Accepted January 5, 2013 The demand for sedation outside of the operating room for diagnostic or therapeutic procedures has recently been dramatically increasing. The Joint Commission International (JCI) is pressing domestic hospitals trying to obtain JCI certification to accept its sedation policies. This article aimed to investigate recent trends in sedation and suggest desirable directions for safe and high-quality sedation. The most active areas in research are procedural sedation, sedation in the intensive care unit (ICU), and pediatric sedation. Patient safety and performance of procedures without complications are the most important goals during sedation. According to the JCI regulation, noninvasive blood pressure, electrocardiography, pulse oximetry and capnography are the basic requirements, and sedation personnel should be separate from those who perform the procedure. Careful preprocedural assessment and tight intra-procedural monitoring for airway obstruction are critical in procedural sedation. Many merits of dexmedetomidine in procedural sedation have been reported despite its hemodynamic risks. Daily intermittent interruption is the main trend in ICU sedation providing better outcomes for mechanically ventilated patients. Analgosedation in the ICU is initial analgesia starting with remifentanil and later adding sedatives if required. Individual readjustment of the dosage using a sedation scoring system is a key requirement for successful results in ICU sedation. Ketofol, mixture of ketamine and propofol, has recently become popular for painful pediatric procedures. Pediatric sedation (especially for those 3 years) with computed tomography or magnetic resonance imaging examination has a greater risk of hypoxia, but pediatric sedation experts are lacking. In conclusion, there is an urgent need for the nationwide establishment of standard sedation regulation, and securing or training sedation specialists. Keywords: Sedation; Ambulatory surgery; Joint Commission on Accreditation 서 론 진정요법은전신마취수준까지요구되지않는수술실밖에서시행되는의학적진단또는치료적시술들의원 활한진행을위해필요하다. 요즘환자들은통증을느끼지않는상태라하더라도시술중조금의불안및불편감도꺼려하기에진정을요구하는경향이크다. 특히, 최근에는의료기관의서비스평가가활발한사회적분위기여서, 환자의의 c Korean Medical Association This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons. org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. 264 진정요법의현황

특 집 료서비스만족도에큰영향을가진진정및진통요법대한관심은점점더커져가고있다. 진정요법이란심폐기능을유지하면서어느정도의의식상태저하를통해환자가불쾌한의료적시술을견뎌낼수있게끔약물을투여하는기술을일컫는다. 이상적인진정이란환자가시술중두려움없이안락하고협조적인상태를보이는것을말한다. 진정의수준은다양한척도들 (sedation scale) 에의해평가및점수화되는데, 1974년에고안된 Ramsay Sedation Scale이그원형이라고할수있다 [1]. 1999년미국마취과학회 (American Society of Anesthesiologists, ASA) 에서는진정의수준을간략히최소진정 (minimal sedation), 중등도진정 (moderate sedation), 깊은진정 (deep sedation), 전신마취 (general anesthesia) 의 4단계로구분하고있다. 과도한진정은호흡정지, 혈압감소및심정지와같은치명적인부작용이생길수도있어세심한모니터링을필요로한다. 다양한의료의영역들에서진정요법은쓰이지만, 가장연구가활발하고이용도가높은세가지진정관련분야를중심으로알아보도록하겠다. 첫번째는진단적내시경검사, 미용성형시술등과같은비수술실시술진정 (procedural sedation), 둘째로중환자실에서의진정, 마지막으로비수술실에서의소아들을위한진정이다. 이들분야에서진정요법의최근동향을파악하여보다안전하고높은수준의진정요법의정착에도움이되고자한다. 비수술실시술진정 2009년이후우리나라를찾는의료관광객수가크게늘어 2011년에는 11만명이넘었고, 2015년에는 30만명시대를열것으로생각된다. 특히, 지난해보건복지부의조사에따르면최근 5년간미용시술을포함한의료관광을목적으로한국을방문하는외국인이두배이상증가했다고보고하고있다. 또한, 매스미디어를통한전문적건강상식의범람, 병원들의최근주력홍보상품인건강검진패키지등을통해진단적내시경검사도꾸준하게늘고있다. 미국의의료통계에따르면통원수술 (ambulatory surgery) 의 55% 는수술실이 아닌시술자의진료실 (office based anesthesia) 에서시행된다고보고하였다 [2]. 최소침습적술기의발전과마취 / 진정을안전하게제공할수있는능력의진보에기인해비수술실시술은점점더늘어가는추세이다. 이와더불어의료공급자측면에서진료만족도제고의수단으로시술진정에대한수요또한증가하고있다. 수술실밖의시술진정시환자안전을위해요구되는핵심적인인자들은다음과같다. 1) 적절한모니터링 ; 2) 직원채용, 기구 / 장비, 응급상황시반응에관련된방침들 ; 3) 유사시신속히작동할수있는마취보조장비 ; 4) 시술및회복공간의적절성 ; 5) 공기교환, 전기적인안전기준및공학적인요건을충족하는의료가스관설비 (piping of medical gases) [3]. 시술진정에필요한모니터링은 ASA에서제시한기본적마취를위한모니터링 ( 심전도, 비침습적혈압, 산소포화도, 호기말이산화탄소, 체온 ) 과동일한항목들을필요로한다 [4]. 호기말이산화탄소감시는일반적으로깊은진정을요하는환자들에게해당하며, 심폐질환자들에게는최소진정의경우에도실시되어야한다. 비수술실시술진정시환자손상의빈도는수술실내에서발생하는것보다오히려더심각한수준으로보고된다 [5]. 그중부적절한산소 / 환기화 (oxygenation/ventilation) 가진정관련의료소송의가장많은원인이었으며, 소송중 62% 는시술중신중한모니터링을통해예방이가능했었던것들로분류되었다. 다음과같은경우들은환자의안전을위해시술진정에적합하지않다 [3]. 1) 다량의혈액손실가능성 ; 2) 6시간이상의긴수술 ; 3) 중환자들 ; 4) 특수한마취나술기를요하는경우 ( 심폐우회술, 흉부, 대뇌수술 ); 5) 시술후환자관리에대한대비가제한적인경우이다. 시술전진정을담당할요원들은계획된시술과정, ASA 신체분류, 기도상태, 과거병력및마취과거력, 알레르기, 금식, 이학적검사소견등에관한꼼꼼한점검을해야한다. 특히, 기도이상 (difficult airway), 병적비만, 중등도이상의수면무호흡증, 만성폐쇄성폐질환, 말기기관부전및 6개월이내심근 / 대뇌경색등에관해서는철저한조사가이뤄져야하겠다. 시술진정에는 propofol, midazolam, ketamine, dexmedetomidine과같은약물이쓰이고, 진통보완에는단기 대한의사협회지 265

Park CS 작용아편유사제인 fentanyl, remifentanil, sufentanil 등이이용된다. 마취가스배출장치가없는환경에서는전정맥내기법 (total intravenous technique) 으로조금씩약용량을증가시키는적정화 (titration) 를통해목표진정수준에이르게하는게안전한진정의방법이다. 1985년처음으로내시경시술에관한보고이래로, propofol은환자의만족감, 회복시간및경제적인측면에서장점이있어지금까지가장널리시술진정에쓰여온약물이다. 하지만, 과잉진정에따르는문제들이심각해시술전신중한환자선정및시술과독립적인숙련된감시인력을필요성이꾸준히제시되어왔다 [6]. 2010년도에진정 / 진통작용을가지지만호흡억제부작용이상대적으로적은 alpha-2 작용제인 dexmedetomidine이국내에소개되어많은관심을받고있다. Dexmedetomidine은 1999 년에미국식품의약청 (Food and Drug Administration) 승인후중환자실에서사용및연구가활발했지만, 현재는다른영역에서도그사용의범위가넓혀지고있다. 안면미용성형분야의한조사에서, dexmedetomidine 투여군은다른진정제들이투약된군에비해탈산소화 (oxygen desaturation) 사건들의발생률이훨씬낮았고, 시술중다른진정 / 진통제의요구량또한적었으며, 시술후항구토제의처방도현저하게적은것으로조사되었다 [7]. 아편유사제중가장짧은상황민감성반감기 (context sensitive half-life) 를가진 remifentanil은대장내시경을위한깊은진정시 propofol과의병용요법으로쓰이는데, 목표농도조절 (target controlled infusion, TCI) 펌프를이용한지속투여방식이수동적인주사 (manual injection) 방식보다호흡억제의빈도가적은것으로조사되었다 [8]. Paracetamol과 cyclooxygenase-2 억제제를포함한비스테로이드소염제, 스테로이드등도시술전병용또는보조투여시아편유사제관련부작용을줄이면서통증을효과적으로덜어줄수있는것으로알려져있다 [9]. 시술후환자들은적절한장비가구비된회복공간에서지속적으로관리되어야하고, 기존의회복실퇴실기준들을만족했을때퇴원하게된다 [10]. 시술후오심과구토 (postperative nausea and vomiting, PONV) 도퇴원을지연시키며진료의만족도를저하시키는중요한요인들중하나이 다. PONV의예방을위해선아편유사제를피하는것이좋지만, 위험성이있는환자들을위해서는 dexamethasone, scopolamine, 5-hydroxytryptamine antagonists 등의항구토제의예방적사용도고려해야한다. 중환자실에서의진정 기계환기를받고있는중환자들의불편감을덜어주기위해서진정 / 진통은당연시받아들여져왔고, 통계에따르면 42-72% 의중환자실환자들에서처방이된다 [11]. 80% 이상의중환자들은필요시 morphine, fentanyl을보완하지만, benzodiazepine 혹은 propofol을기반으로한지속적진정-수면요법을받아왔다 [12]. 이방식은기계환기로부터의이탈지연및중환자실체류기간의연장과같은심각한부작용과연관되는것으로알려졌다 [13,14]. 요즘은 remifentanil 을우선적으로주고, 필요시 propofol을추가하며, 그리고최소진정을목표로매일주기적으로일정시간동안진정을중단하는시간을삽입시키는진통진정 (analgosedation) 개념이중환자실진정요법의대세로자리잡고있다. 이는약제의투여량을감소시켜기계환기이탈과관련된부작용을줄이는데긍정적인결과를보이고있다 [15]. 중환자실진정의목표는환자들의불편감, 불안, 초조 (agitation) 를감소시키고, 기계환기기와의이상동조 (dysynchrony) 로인한호흡량및산소소모량의증가를막아환자의안정및안전을도모하는것이다. 논란이있기는하지만기존에중환자실에서널리쓰이던 benzodiazepine, morphine, fentany은중환자실에서의사망률, 체류기간, 퇴원후인지기능손상의예측인자인섬망 (delirium) 의발생원인이될수있다는몇몇보고들이있다 [16,17]. 진정을받는모든중환자들은개인별임상상황에맞는진정의목표를가지며, 주기적평가를통해진정의정도가재조정되어야한다. Ramsay Sedation Scale, Riker Sedation Agitation Score [18], Richmond Agitation-Sedation Scale [19] 등과같은다면적접근법의척도들로진정수준은평가된다. 최근에는각성의정도를수치화하는 4채널뇌파감시장치인 bispectral index (BIS) 가많이쓰이는데, 2002년 Society 266 진정요법의현황

특 집 of Critical Care Medicine Sedation Guideline은중환자에게서 BIS 모니터링은그유용도를제고할필요가있다고하였다. BIS는근이완제를투여받는환자들에게다른진정척도들이사용될수없는경우에보조적진정감시장치로서그활용성이한정된다 [20]. 중환자들을위한이상적인진정제의조건은경제적이고, 혈류역학적효과및호흡억제가경미해야하고, 약물상호작용이없고활성대사산물의생성이적어야하며, 신체기관에독성이적으면서짧은상황민감성반감기를가져장기기능과무관한대사기전을가져야한다. 불행하게이와모두일치하는진정제를찾기는쉽지않지만, GABA 작용제인 propofol, benzodiazepines (midazolam, lorazepam) 이가장많이사용되어왔고, alpha-2 작용제인 dexmedetomidine 이최근에증가추세에있다. Propofol은아편유사제시도후일차적으로선택 (first line) 되는진정제로서흔히 TCI를통한지속주입방식으로투여된다. Propofol은약효의발현이신속하고지속주입후중지시빠른시간내종료되며, 조절이용이하고, 수시로신경학적검사가가능한장점때문에중환자실에서가장흔하게쓰인다. 하지만저혈압, 고콜레스테롤혈증, 췌장염, 호흡억제, 프로포폴주입증후군 (propofol infusion syndrome) [21] 과같은합병증이생길수있어신중한모니터링이필요하다. 앞에서언급했듯이중환자실에서 dexmedetomidine 사용과관련된임상연구가매우활발하다. Midazolam과비교시 dexmedetomidine 은기계환기시간, 중환자실체류기간, 사망률에서는차이가없었지만, 섬망 (delirium) 의발생률에있어서는두드러지게낮았다 [22]. 최근에 propofol과비교한연구에서는, 환자와의상호작용에대한 visual analogue scale 평가에서 dexmedetomidine이더우수한결과를보였다 [23]. 비수술실소아진정 방사선학적검사, 심장도관삽입 (cardiac catheterization), 소아중환자실, 응급실과같은수술실밖에서소아를대상으로한진정이늘고있다. 소아진정관련연구도최근 10년간약 2.5배가까이증가되는추세를보이고있다. 과거 소아진정은해당과주치의들이자체적으로해결했었지만, 최근에는병원차원에서마취통증과책임하에진정전문인력을배치하고체계적인소아진정의알고리즘을개발하려고노력하는중이다. 소아진정에는 ketamine, etomidate, midazolam, propofol, dexmedetomidine와같은정맥마취제들과흡입마취제인아산화질소 (nitrous oxide) 가흔히포함된다. 항불안작용및진통효과를가진아산화질소는약 80% 이상의소아진정에서 ketamine이나국소마취제사용시보조적으로사용된다 [24]. 저산소증의위험성이있지만임상의많은경우에서산소공급없이단독으로쓰이는것으로알려져있다 [25]. Propofol은가장많이쓰이는진정제인데, 요즘은 ketamine의사용이늘어이두약물의혼합제제인 Ketofol 의형태로통증을유발할수있는소아시술시많이쓰인다 [26]. Propofol의소아에서의안전성에대해서는많은이견들이있지만, 다양한임상경험및진정훈련을거친의료인들에는 propofol로인한부작용발생은그다지큰문제가되지않는것으로결론짓고있다. 컴퓨터단층촬영 (computed tomography, CT) 이나자기공명영상 (magnetic resonance imaging, MRI) 촬영과같은방사선학적검사시환아의안전과높은질의영상을얻기위해서진정이필요하다. CT나 MRI 촬영을받는대부분의환아들은신경계질환, 혈관기형, 소아종양과같은선천적인질병을갖는경우가많고, 간질, 지능저하도흔히동반되어진정또는마취의필요성이크다고할수있다. 방사선촬영시소아진정의목표는환아의안전확보, 불편감및통증최소화, 불안과정신적충격최소화, 기억상실최대화, 영상촬영을위한움직임조절, 안전한퇴원을위한완전한회복이다. 금식, 정맥관확보, 생체활력징후모니터링은전신마취와똑같이준비하여야하며, 진정을실시하는자는기구나소아기도를다루는데있어많은경험을가진자이어야한다. 일반적으로장애를가진환아에서진정중저산소증발생위험도는정상인의세배가넘는것으로알려져있다 [27]. 그러므로, 전신마취와동일한시설을구비하고기도확보및응급구명을위한장비들을즉각적으로사용할수있도록꼼꼼한사전점검을마친상태에서진정을시작해야한다. 3세이상, 몸무게 10 kg 이상의특별한기도이상이없는 대한의사협회지 267

Park CS 소아들은진정이전신마취의대안으로추천될지도모르지만, 3세이하영아, 주요동반질환을가진경우에는시술중기도폐쇄의위험성이커전신마취를선택해야한다. 기도폐쇄는복합적진정약제의사용, 부적절한시술전환자평가, 시술중철저하지않은모니터링, 약물부작용등에기인한다 [28]. 소아진정요법중심장관련합병증은거의없으나기도폐쇄가빨리해결되지않을경우에유발될수도있다. 소아진정에있어공급자의숙련도와경험은무엇보다중요한항목이다. 일부대형대학병원들이마취통증과의책임으로소아진정을위탁하고있으나, 소아진정전문인력및필수적진정기본장비들은절대적으로부족한상황이기에환아를담당하는해당과의적극적인지원을포함한국가적인차원의소아진정체계의설립이시급하다고볼수있다. 록들 ( 진정전평가서, 동의서및진정중기록, 회복실퇴실기준 ) 의철저한구비와표준화된진정관련시설완비를지시하고있다. 진정후환자만족도, 안전도, 효율성과같은환자결과에대해서도 quality improvement and patient safety 부분을통해진정요법의질관리를지시하고있는상황이다 [29]. 국가적차원의진정에관한표준지표는아직마련되어있지않고, JCI 인증평가를추진하는의료기관별로통일되지않은진정방침만있는게우리의현실이다. 진정요법에대한수요증대와의료의세계화흐름에발맞춰, 진정요법의표준화된가이드라인이어느때보다절실한시점이다. 결론 Joint Commission International 하에서의진정요법 최근국내대형대학병원들은국제적의료평가기관으로 부터인증을획득하려고공급되는의료서비스의구조및관 행들의국제적표준화를추진하고있다. 미국내비영리의 료평가기관인 Joint Commission 는 1997 년부터 Joint Commission International (JCI) 이란분과를통해국제적 표준의료평가확산을목적으로그영역을확장하고있다. 현재, 국내의많은병원들이 JCI 인증을시도하고있기에, 진 정에관련한 JCI 의규정들을살펴볼필요성이있다. 먼저, JCI 규정에서는진정을실시하는자들에대한엄격 한자격규정을요구하고있다. 꼭마취과의사일필요는없 지만, 진정에참여하는자는환자시술과는반드시독립적이 어야한다. 깊은진정일경우에는보다더높은기준의훈련 과자격을요구하고있다. 기본적으로 advanced cardiac life support 자격증획득을요구하고있으며, 진정전후환 자에대한전문적평가나진정중약물투여및모니터링, 합 병증이생겼을때적절하고신속한대처 ( 삽관및후두마스 크삽입등 ) 가가능할수있도록일정한교육기간및자격을 필요로하고있다. 의료기관에대해서도진정을실시하는 자들에대한체계적교육및평가시스템, 각종진정관련기 진단적검사나미용목적또는최소침습적시술이증가하 고있고, 이에따른의료서비스질과관련해진정및진통의 요구는점점증가하고있다. 하지만, 전문진정인력의부족, 진정제에대한이해부족, 환자모니터링의소홀은항시의 료사고의소지를가지고있다. 비수술실시술중진정에대 한합리적인보상수가의책정과소아진정을포함한진정관 련독립적부서의설립, 국가적인표준진정지침의마련은 진정과관련해우리가앞으로해결해야할과제라고할수 있겠다. 핵심용어 : 진정, 통원수술, 의료기관평가 REFERENCES 1. Ramsay MA, Savege TM, Simpson BR, Goodwin R. Controlled sedation with alphaxalone-alphadolone. Br Med J 1974; 2:656-659. 2. Pino RM. The nature of anesthesia and procedural sedation outside of the operating room. Curr Opin Anaesthesiol 2007; 20:347-351. 3. Eichhorn V, Henzler D, Murphy MF. Standardizing care and monitoring for anesthesia or procedural sedation delivered outside the operating room. Curr Opin Anaesthesiol 2010;23: 494-499. 4. American Society of Anesthesiologists. Standards for basic anesthetic monitoring [Internet]. American Society of Anesthesiologists; 2011. Available from: http://www.asahq.org/for- Members/~/media/For%20Members/documents/Standards%20 268 진정요법의현황

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Park CS Peer Reviewers Commentary 진정요법은많은진료현장에서시행되고있으며, 최근의학의발달과사회변화에따라서불안및불편을피하고자하는환자의요구증대및의료진의적합한진료를위하여그필요성이증가하고있다. 이러한진정요법은적절하게시행되었을경우환자의안락하고협조적인상태에서진료의원활한진행을이룰수있으며, 환자와의료진의만족도를증가시킬수있다. 그러나진정요법은환자의안전성을최우선으로고려해야하며과도한진정요법으로인한부적절한산소 / 환기화및심혈관계억제예방및부작용의최소화가필요하다. 따라서이를위해서는진정요법에대한숙련되고경험있는의료진과장비들이요구되고있는상황이다. 이러한상황에서본논문은진정요법이특히많이요구되는비수술적시술진정, 중환자실에서의진정, 그리고비수술실소아진정에대하여간결하게요약하여소개하고있다. 따라서이내용들은실제진료현장에서안전하고높은수준의진정요법의사용에도움이될것으로기대한다. [ 정리 : 편집위원회 ] 270 진정요법의현황