Department of Internal Medicine, Hanyang University Guri Hospital, Hanyang University College of Medicine, Gyeonggi-do, Korea.
Division of Gastroenterology, Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hallym University College of Medicine, Gyeonggi-do, Korea.
Gastrointest Endosc. 2018 Jan;87(1):174-184. doi: 10.1016/j.gie.2017.05.050. Epub 2017 Jun 10.
Etomidate is a short-acting intravenous hypnotic with a safety profile that is superior to alternative drugs such as propofol. However, there is a lack of evidence on the safety of etomidate in ERCP. The objective of this study was to compare efficacy and safety profiles of etomidate and propofol for endoscopic sedation.
This single-center, randomized, double-blind, noninferiority trial included patients with American Society of Anesthesiologists (ASA) physical status I to II who had been scheduled for ERCP. All patients received .05 mg/kg midazolam intravenously as pretreatment before receiving etomidate or propofol. Either etomidate or propofol was then administered according to group allocation. The primary endpoint was an overall respiratory event. A noninferiority margin of 10% was assumed.
Sixty-three and 64 patients were enrolled in the etomidate and propofol groups, respectively. Respiratory events were identified in 10 patients (15.6%) in the etomidate group and 16 patients (25.4%) on the propofol group, with a rate difference of -9.8% (1-sided 97.5% confidence interval, -∞ to 4.2%). The overall incidence of cardiovascular events tended to be higher in the etomidate group (67.2% vs 50.8%, P = .060). In particular, tachycardia (heart rate > 100 beats/min) was more common in the etomidate group than in the propofol group (64.1% vs 34.9%, P = .001). Transient hypotension tended to be less common in the etomidate group (6.3 vs 15.9%, P = .084).
Etomidate-based sedation during ERCP was noninferior to propofol-based sedation in terms of the overall incidence of respiratory events in patients with ASA physical status I to II. (International Clinical Trials Registry Platform number: KCT0001926.).
依托咪酯是一种短效静脉催眠药，其安全性优于丙泊酚等替代药物。然而，关于依托咪酯在 ERCP 中的安全性缺乏证据。本研究的目的是比较依托咪酯和丙泊酚用于内镜镇静的疗效和安全性。
这是一项单中心、随机、双盲、非劣效性试验，纳入了美国麻醉医师学会（ASA）身体状况 I 至 II 级的拟行 ERCP 的患者。所有患者在接受依托咪酯或丙泊酚前均静脉注射 0.05mg/kg 咪达唑仑预处理。然后根据分组给予依托咪酯或丙泊酚。主要终点是总体呼吸事件。假设非劣效性边界为 10%。
分别有 63 例和 64 例患者纳入依托咪酯组和丙泊酚组。依托咪酯组有 10 例（15.6%）患者发生呼吸事件，丙泊酚组有 16 例（25.4%）患者发生呼吸事件，差异率为-9.8%（单侧 97.5%置信区间，-∞至 4.2%）。依托咪酯组心血管事件的总发生率较高（67.2% vs 50.8%，P =.060）。特别是依托咪酯组心动过速（心率>100 次/分）的发生率高于丙泊酚组（64.1% vs 34.9%，P =.001）。依托咪酯组短暂性低血压的发生率较低（6.3% vs 15.9%，P =.084）。
在 ASA 身体状况 I 至 II 级的患者中，依托咪酯镇静在 ERCP 中与丙泊酚镇静相比，在总体呼吸事件发生率方面非劣效。（国际临床试验注册平台编号：KCT0001926。）
