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非麻醉医师不应被允许给予异丙酚用于操作镇静:21 个欧洲国家麻醉学会的共识声明。

Non-anaesthesiologists should not be allowed to administer propofol for procedural sedation: a Consensus Statement of 21 European National Societies of Anaesthesia.

机构信息

Department of Anaesthesiology and Intensive Care, Sheba Medical Center, Tel Aviv University, Tel Aviv, Israel.

出版信息

Eur J Anaesthesiol. 2011 Aug;28(8):580-4. doi: 10.1097/EJA.0b013e328348a977.

Abstract

Propofol, which is the most commonly used drug for induction of general anaesthesia, has also become a popular drug for procedural sedation. Because its use may be associated with serious and potentially fatal side-effects, the manufacturers of propofol restrict its use solely to personnel trained in general anaesthesia. In spite of this warning, the use of propofol for procedural sedation by non-anaesthesiologists is rapidly expanding in many countries. Recently, the US Food and Drugs Administration (FDA) denied a petition from gastroenterologists seeking the removal of this particular restriction. This unequivocal ruling of the FDA received strong support from the American Society of Anesthesiologists (ASA). At about the same time, the European Society of Anaesthesiology (ESA), together with various European gastroenterology societies, published new guidelines entitled 'Non-anaesthesiologist Administration of Propofol for Gastrointestinal Endoscopy' (NAAP). Following publication of the NAAP guidelines, many reservations have been expressed by ESA member societies and individuals, dealing with professional, political, procedural and safety-oriented concerns. Out of concern for patient safety, and in order to officially and publicly dissociate themselves from the NAAP guidelines, 21 national societies of anaesthesiology in Europe, all of whom are ESA members, have signed a Consensus Statement confirming that due to its significant well known risks, propofol should be administered only by those trained in the administration of general anaesthesia.

摘要

丙泊酚是最常用于全身麻醉诱导的药物,也已成为一种常用的镇静程序药物。由于其使用可能与严重且潜在致命的副作用有关,丙泊酚的制造商将其使用仅限于接受过全身麻醉培训的人员。尽管有此警告,但许多国家的非麻醉师正在迅速扩大将丙泊酚用于镇静程序的使用。最近,美国食品和药物管理局(FDA)拒绝了胃肠病学家提出的取消这一特殊限制的请求。FDA 的这一明确裁决得到了美国麻醉师学会(ASA)的大力支持。大约在同一时间,欧洲麻醉学会(ESA)与各种欧洲胃肠病学会一起发布了题为“非麻醉师管理丙泊酚用于胃肠道内窥镜检查”(NAAP)的新指南。NAAP 指南发布后,ESA 成员协会和个人对涉及专业、政治、程序和安全方面的问题表示了许多保留意见。出于对患者安全的关注,并为了正式和公开地与 NAAP 指南划清界限,欧洲的 21 个国家麻醉学会,他们都是 ESA 的成员,签署了一份共识声明,确认由于其显著的已知风险,丙泊酚应由接受过全身麻醉管理培训的人员使用。

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