<p>Endoscopic retrograde cholangiopancreatography (ERCP) is among the most complex and technically demanding procedures in gastrointestinal endoscopy. Hence, it requires a high level of specialized expertise. Proper sedation is an important factor for ensuring that the procedure is completed safely and successfully. In particular, to decrease the risk of major ERCP-related adverse events such as bleeding, perforation, and pancreatitis, it is essential to achieve a level of sedation that guarantees both operator satisfaction and patient comfort. However, according to a prospective study on sedation in endoscopic practice using traditional sedative agents, deep sedation accompanied by respiratory depression occurs in up to 85% of ERCP cases. Based on this finding, ERCP itself is a significant risk factor for deep sedation [<span>1</span>].</p><p>In endoscopic procedures, benzodiazepines, particularly midazolam, are widely used as hypnotic sedatives in routine clinical settings. However, according to the current Japanese guidelines on sedation in endoscopic practice [<span>2</span>], no specific benzodiazepine agent has been definitely established as suitable for therapeutic endoscopic interventions, including ERCP. Moreover, no such agent is currently covered by the national health insurance system in Japan. In ERCP, midazolam alone or in combination with analgesics such as pethidine hydrochloride has traditionally been used. Recently, propofol-based sedation has become increasingly common due to its favorable recovery profile. A previous meta-analysis examined nine randomized controlled trials (RCTs) comparing propofol with traditional sedative agents for sedation in therapeutic endoscopic procedures including ERCP. Results showed that propofol had a significantly shorter recovery time than traditional sedative agents, although there were no significant differences in the incidence of hypoxemia or hypotension between the two types of drugs [<span>3</span>]. However, unlike benzodiazepines, propofol has no specific reversal agent; therefore, particular caution is required regarding its dose-dependent risk of cardiovascular and respiratory depression. In contrast to western countries, where anesthesiologists typically manage sedation for ERCP, endoscopists in Japan often assume this role. Therefore, they must have adequate training in airway management to ensure patient safety. At our institution, propofol-based sedation has been used for ERCP for over a decade. Further, only endoscopists who have been formally certified by the hospital to perform sedation, after receiving training directly from anesthesiologists, which includes endotracheal intubation techniques, are permitted to administer propofol. Moreover, bispectral index (BIS) monitoring is routinely utilized to maintain a constant and optimal depth of sedation [<span>4</span>]. Accordingly, the limited availability of sedative agents for ERCP, none of which are covered by insurance in Japan,
内窥镜逆行胰胆管造影(ERCP)是胃肠道内窥镜中最复杂、技术要求最高的手术之一。因此,它需要高水平的专业知识。适当的镇静是确保手术安全成功完成的重要因素。特别是,为了降低与ercp相关的主要不良事件(如出血、穿孔和胰腺炎)的风险,必须达到一定程度的镇静,以保证操作人员的满意度和患者的舒适度。然而,根据一项关于内镜下使用传统镇静剂镇静的前瞻性研究,高达85%的ERCP病例发生深度镇静并伴有呼吸抑制。基于这一发现,ERCP本身是深度镇静bb0的重要危险因素。在内窥镜手术中,苯二氮卓类药物,特别是咪达唑仑,在常规临床环境中被广泛用作催眠镇静剂。然而,根据日本目前的内镜镇静指南[2],没有明确确定特定的苯二氮卓类药物适用于治疗性内镜干预,包括ERCP。此外,目前日本的国民健康保险制度不包括这种代理人。在ERCP中,传统上使用咪达唑仑或与盐酸哌替啶等镇痛药联合使用。最近,基于异丙酚的镇静由于其良好的恢复概况而变得越来越普遍。先前的一项荟萃分析检查了9项随机对照试验(rct),比较异丙酚与传统镇静剂在治疗性内窥镜手术(包括ERCP)中的镇静作用。结果显示,异丙酚恢复时间明显短于传统镇静剂,但两种药物在低氧血症和低血压发生率方面无显著差异。然而,与苯二氮卓类药物不同,异丙酚没有特定的逆转剂;因此,需要特别注意其对心血管和呼吸抑制的剂量依赖性风险。与西方国家相比,麻醉师通常负责ERCP的镇静,而日本的内窥镜医生通常承担这一角色。因此,他们必须接受足够的气道管理培训,以确保患者安全。在我们的机构,基于异丙酚的镇静已经用于ERCP超过十年。此外,只有经医院正式认证的内窥镜医师,在接受麻醉师的培训(包括气管内插管技术)后,才被允许使用异丙酚。此外,通常使用双谱指数(BIS)监测来维持恒定和最佳的镇静深度。因此,ERCP镇静剂的有限可用性,以及一些持续存在的安全问题都是尚未解决的挑战,必须加以解决。最近,雷马唑仑已成为一种用于诱导和维持全身麻醉的新型催眠镇静剂,并于2020年在日本首次获批临床使用。雷马唑仑是一种短效苯二氮卓类药物,通过作用于γ-氨基丁酸a型受体[5]发挥镇静作用。它的一些药理特征与咪达唑仑相似,包括心血管抑制风险降低、注射疼痛可忽略不计以及与氟马西尼相同的可逆性。雷马唑仑最显著的特点是全身清除快,半衰期短。与咪达唑仑相比,雷马唑仑的清除率大约快三倍(70.3 vs. 23.0 L/h),末端半衰期显著缩短(0.75 vs. 2.89 h)。此外,雷马唑仑的代谢独立于细胞色素P450系统,从而降低了药物-药物相互作用的可能性。在全身麻醉领域,比较雷马唑仑与异丙酚的荟萃分析已经发表,越来越多的证据表明,雷马唑仑在降低低氧血症、心动缓和注射痛的风险方面具有优势[7,8]。在包括ERCP在内的治疗性内镜实践中,雷马唑仑用于镇静的有效性和安全性尚未确定,因为迄今为止只有有限数量的研究报道。在最新一期的《消化道内窥镜》杂志上,Kim等人报道了一项系统综述和荟萃分析,比较了在ERCP中使用雷马唑仑和异丙酚的镇静效果。该研究纳入了来自5项随机对照试验(4项在中国进行,1项在韩国进行)的965名参与者,并评估了雷马唑仑与传统异丙酚镇静在ERCP期间的疗效和安全性。除了传统的荟萃分析外,还进行了试验序列分析(TSA),以控制由于纳入的试验数量较少而导致的I型误差。 作者是《消化内窥镜》杂志的副主编。其他作者声明本文不存在利益冲突。本文链接到https://doi.org/10.1111/den.15078。
{"title":"Reconsidering Sedation for Endoscopic Retrograde Cholangiopancreatography: The Potential of Remimazolam","authors":"Kosuke Minaga, Akane Hara, Masatoshi Kudo","doi":"10.1111/den.70034","DOIUrl":"10.1111/den.70034","url":null,"abstract":"<p>Endoscopic retrograde cholangiopancreatography (ERCP) is among the most complex and technically demanding procedures in gastrointestinal endoscopy. Hence, it requires a high level of specialized expertise. Proper sedation is an important factor for ensuring that the procedure is completed safely and successfully. In particular, to decrease the risk of major ERCP-related adverse events such as bleeding, perforation, and pancreatitis, it is essential to achieve a level of sedation that guarantees both operator satisfaction and patient comfort. However, according to a prospective study on sedation in endoscopic practice using traditional sedative agents, deep sedation accompanied by respiratory depression occurs in up to 85% of ERCP cases. Based on this finding, ERCP itself is a significant risk factor for deep sedation [<span>1</span>].</p><p>In endoscopic procedures, benzodiazepines, particularly midazolam, are widely used as hypnotic sedatives in routine clinical settings. However, according to the current Japanese guidelines on sedation in endoscopic practice [<span>2</span>], no specific benzodiazepine agent has been definitely established as suitable for therapeutic endoscopic interventions, including ERCP. Moreover, no such agent is currently covered by the national health insurance system in Japan. In ERCP, midazolam alone or in combination with analgesics such as pethidine hydrochloride has traditionally been used. Recently, propofol-based sedation has become increasingly common due to its favorable recovery profile. A previous meta-analysis examined nine randomized controlled trials (RCTs) comparing propofol with traditional sedative agents for sedation in therapeutic endoscopic procedures including ERCP. Results showed that propofol had a significantly shorter recovery time than traditional sedative agents, although there were no significant differences in the incidence of hypoxemia or hypotension between the two types of drugs [<span>3</span>]. However, unlike benzodiazepines, propofol has no specific reversal agent; therefore, particular caution is required regarding its dose-dependent risk of cardiovascular and respiratory depression. In contrast to western countries, where anesthesiologists typically manage sedation for ERCP, endoscopists in Japan often assume this role. Therefore, they must have adequate training in airway management to ensure patient safety. At our institution, propofol-based sedation has been used for ERCP for over a decade. Further, only endoscopists who have been formally certified by the hospital to perform sedation, after receiving training directly from anesthesiologists, which includes endotracheal intubation techniques, are permitted to administer propofol. Moreover, bispectral index (BIS) monitoring is routinely utilized to maintain a constant and optimal depth of sedation [<span>4</span>]. Accordingly, the limited availability of sedative agents for ERCP, none of which are covered by insurance in Japan,","PeriodicalId":159,"journal":{"name":"Digestive Endoscopy","volume":"38 1","pages":""},"PeriodicalIF":4.7,"publicationDate":"2025-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/den.70034","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145042368","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}