Sieg Andreas, Beck Sebastian, Scholl Sabine G, Heil Franz J, Gotthardt Daniel N, Stremmel Wolfgang, Rex Douglas K, Friedrich Kilian
J Gastroenterol Hepatol. 2014 Mar;29(3):517-23. doi: 10.1111/jgh.12458.
Since 2008, there exists a German S3-guideline allowing non-anesthesiological administration of propofol for gastrointestinal endoscopy. In this prospective, national, multicenter study, we evaluated the safety of endoscopist-administered propofol sedation (EDP) in German outpatient practices of Gastroenterology.
In this multicenter survey of 53 ambulatory practices of Gastroenterology, we prospectively evaluated 24 441 patients that had received EDP. We recorded adverse events during the endoscopic procedure and additionally retrieved questionnaires investigating subjective parameters 24 h after the endoscopic procedure.
In 24 441 patients 13 793 colonoscopies, 6467 esophagogastroduodenoscopies, and 4181 double examinations were performed. In this study, 52.1% of the patients received propofol mono-sedation, and 47.9% received a combination of midazolam and propofol. Major adverse events occurred in four patients (0.016%) enrolled to this study (three mask ventilations and one laryngospasm). Minor adverse events were observed in 112 patients (0.46%) with hypoxemia being the most common minor event. All patients with adverse events recovered without persistent impairment. Minor adverse events occurred more frequently in patients sedated with propofol mono compared to propofol and midazolam (P < 0.0001) and correlated with increasing propofol dosages (P < 0.001; Pearson correlation coefficient r = 0.044). Twenty-four hours after the endoscopy, patients sedated with propofol plus midazolam stated a significantly reduced sensation of pain (P < 0.01) and improved symptoms of dizziness, nausea and vomiting (P < 0.001) compared to patients having received propofol mono-sedation.
Four years after the implementation of a German S3-Guideline for endoscopic sedation, we demonstrated that EDP is a safe procedure.
自2008年起，德国有一项S3指南允许在胃肠内镜检查中由非麻醉专业人员给予丙泊酚。在这项前瞻性、全国性、多中心研究中，我们评估了在德国胃肠病门诊实践中由内镜医师给予丙泊酚镇静（EDP）的安全性。
在这项对53家胃肠病门诊进行的多中心调查中，我们前瞻性评估了24441例接受EDP的患者。我们记录了内镜检查过程中的不良事件，并另外收集了内镜检查24小时后调查主观参数的问卷。
对24441例患者进行了13793例结肠镜检查、6467例食管胃十二指肠镜检查和4181例联合检查。在本研究中，52.1%的患者接受丙泊酚单一镇静，47.9%的患者接受咪达唑仑和丙泊酚联合使用。本研究纳入的4例患者（0.016%）发生了严重不良事件（3例面罩通气和1例喉痉挛）。112例患者（0.46%）观察到轻微不良事件，其中低氧血症是最常见的轻微事件。所有发生不良事件的患者均康复，无持续损伤。与丙泊酚和咪达唑仑联合使用相比，接受丙泊酚单一镇静的患者轻微不良事件发生率更高（P<0.0001），且与丙泊酚剂量增加相关（P<0.001；Pearson相关系数r=0.044）。与接受丙泊酚单一镇静的患者相比，内镜检查24小时后，接受丙泊酚加咪达唑仑镇静的患者疼痛感觉明显减轻（P<0.01），头晕、恶心和呕吐症状改善（P<0.001）。
在德国内镜镇静S3指南实施四年后，我们证明EDP是一种安全的操作。
