儿童手术室外诊疗操作丙泊酚镇静／麻醉引起不良反应的性质和发生率：来自儿童镇静研究协会的报道

目的通过分析由一大批儿科专家提供的儿童接受手术室外镇静或麻醉的前瞻性数据资料，来描述丙泊酚镇静或麻醉引起不良反应的性质和发生率。方法数据搜集由儿童镇静研究协会完成，此协会是致力于提高儿童镇静、麻醉水平的国际性合作机构。前瞻性选取在临床操作时需辅助镇静或麻醉的患儿。初步准入标准为需要某种形式的镇静或麻醉来完成手术室外诊疗操作的患儿，没有排除标准。采用以网络为基础的数据收集工具，采集的资料有：人口统计学资料、原发病、并存疾病、临床操作、使用药物、操作时间和苏醒时间、药物剂量、麻醉结果、气道干预和不良反应。本研究评价所有使用丙泊酚作为主要镇静或麻醉药物的病例。结果在研究期间2004年7月1日至2007年9月1日，共有37家机构提供了49836例丙泊酚镇静或麻醉的病例。无一例死亡，其中心肺复苏2次，镇静或麻醉中误吸发生了4次。非严重事件中血氧饱和度低于90％持续超过30秒发生较多（每10000例发生154次）。中枢性窒息或气道梗阻每10000例中发生575次，喘鸣、喉痉挛、分泌物增多和呕吐发生率分别为每10000例50、96、341和49次。意外住院者为每10000例中7．1次。一项未经调整的分析显示，麻醉医师和其他医务人员相比，肺部不良反应的发生率不存在差别。结论本研究报道了儿童手术室外诊疗操作辅助丙泊酚镇静或麻醉的大量病例。搜集到的数据显示，在一些可以提供高质量镇静／麻醉服务的机构中，采用丙泊酚镇静或麻醉难免出现严重不良反应。但这一临床操作的安全性取决于整个系统处理非严重并发症的能力。因此，本研究揭示了培训和认证丙泊酚镇静或麻醉实施者的影响因素，以及提高此药物临床应用安全性所需的相关团队的特征。

BACKGROUND： We used a large database of prospeaively collected data on pediatric sedation/anesthesia outside the operating room provided by a wide range of pediatric specialists to delineate the nature and frequency of adverse events associated with propofol-based sedation/anesthesia care. PATIENTS AND METHODS： Data were collected by the Pediatric Sedation Research Consortium, a collaborative group of institutions dedicated to improving sedation/anesthesia care for children internationally. Members prospectively enrolled consecutive patients receiving sedation or sedationanesthesia for procedures. The primary inclusion criterion was the need for some form of sedation/anesthesia to perform a diagnostic or therapeutic procedure outside the operating room. There were no exclusion criteria. Data on demographics, primary illness, coexisting illness, procedure performed, medications used, procedure and recovery times, medication doses outcomes of anesthesia, airway interventions and adverse events were collected and reported using web-based data collection tool. For this study, we evaluated all instances where propofol was used as the primary drug in the sedation/anesthesia technique. RESULTS： Thirty-seven locations submitted data on 49 836 propofol sedation/anesthesia encounters during the study period from July 1,2004 until September 1, 2007. There were no deaths. Cardiopulmonary resuscitation was required twice. Aspiration during sedation/anesthesia occurred four times. Less serious events were more common with O2 desaturation below 90% for more than 30 s, occurring 154 times per 10 000 sedation/anesthesia administrations. Central apnea or airway obstruction occurred 575 times per 10 000 sedation/anesthesia administrations. Stridor, laryngospasm, excessive secretions, and vomiting had frequencies of 50, 96, 341, and 49 per 10 000 encounters, respectively. Unexpected admissions （increases in levels of care required） occurred at a rate of 7. 1 per 10 000 encounters. In an unadiusted analysis, the rate of pulmonary adverse events was not different for anesthesiologists versus other providers. CONCLUSIONS： We report the largest series of pediat-ric propofol sedation/anesthesia for procedures outside the operating room. The data indicate that propofol sedation/anesthesia is unlikely to yield serious adverse outcomes in a colection of institutions with highly motivated and organized sedation/ anesthesia services. However, the safety of this practice is dependent on a system＇s ability to manage less serious events. We propose that our data suggest variables for training and credentialing providers of propofol sedation/anesthesia and the system characteristics that promote safe use of this drug.