Background and Aims

ERCP is a complex procedure often performed in patients at high risk for sedation-related adverse events (SRAEs). However, there is no current standard of care with regard to mode of sedation and airway management during ERCP. The aim of this study was to assess the safety of general endotracheal anesthesia (GEA) versus propofol-based monitored anesthesia care (MAC) without endotracheal intubation in patients undergoing ERCP at high risk for SRAEs.

Methods

Consecutive patients undergoing ERCP at high risk for SRAEs at a single center were invited to participate in this randomized controlled trial comparing GEA and MAC. Inclusion criteria were STOP-BANG score ≥3, abdominal ascites, body mass index ≥35, chronic lung disease, American Society of Anesthesiologists class >3, Mallampati class 4 airway, and moderate to heavy alcohol use. Exclusion criteria were preceding EUS, emergent ERCP, tracheostomy, unstable airway, gastric outlet obstruction or delayed gastric emptying, and altered foregut anatomy. The primary endpoint was composite incidence of SRAEs: hypoxemia, use of airway maneuvers, hypotension requiring vasopressors, sedation-related procedure interruption, cardiac arrhythmia, and respiratory failure. Secondary outcomes included procedure duration, cannulation success, in-room time, and immediate adverse events.

Results

Two hundred patients (mean age, 61.1 ± 13.6 years; 36.5% women) were randomly assigned to GEA (n = 101) or MAC (n = 99) groups. Composite SRAEs were significantly higher in the MAC group compared with the GEA group (51.5% vs 9.9%, P < .001). This was primarily driven by the frequent need for airway maneuvers in the MAC group. Additionally, ERCP was interrupted in 10.1% of patients in the MAC group to convert to GEA because of respiratory instability refractory to airway maneuvers (n = 8) or significant retained gastric contents (n = 2). There were no statistically significant differences in cannulation, in-room, procedure, or fluoroscopy times between the 2 groups. All patients undergoing GEA were successfully extubated in the procedure room at completion of ERCP, and Aldrete scores in recovery did not differ between the 2 groups. There were no immediate adverse events.

Conclusion

In patients at high risk for SRAEs undergoing ERCP, sedation with GEA is associated with a significantly lower incidence of SRAEs, without impacting procedure duration, success, recovery, or in-room time. These data suggest that GEA should be used for ERCP in patients at high risk for SRAEs (Clinical trial registration number: NCT02850887.)

中文翻译：

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评估高风险患者一般气管内麻醉与监测麻醉护理以及ERCP期间与镇静相关的不良事件发生率的随机对照试验

背景和目标

ERCP是一项复杂的程序，通常在与镇静相关的不良事件（SRAEs）具有高风险的患者中进行。但是，目前尚无关于ERCP期间镇静方式和气道管理的护理标准。这项研究的目的是评估在高SRAE发生风险的ERCP患者中，不进行气管内插管的情况下，一般气管内麻醉（GEA）与基于异丙酚的监测性麻醉护理（MAC）的安全性。

方法

邀请在单个中心接受ERCP高风险SRAE的连续患者参加比较GEA和MAC的随机对照试验。入选标准为：STOP-BANG评分≥3，腹水，体重指数≥35，慢性肺病，美国麻醉医师学会> 3级，Mallampati 4类气道，以及中度至重度饮酒。排除标准为EUS之前，急诊ERCP，气管切开术，气道不稳定，胃出口梗阻或胃排空延迟，以及前肠解剖改变。主要终点是SRAE的复合发生率：低氧血症，气道操作的使用，需要降压药的低血压，与镇静有关的手术中断，心律不齐和呼吸衰竭。次要结果包括手术时间，插管成功，室内时间，

结果

将200名患者（平均年龄61.1±13.6岁；女性36.5％）随机分配到GEA（n = 101）或MAC（n = 99）组。与GEA组相比，MAC组的复合SRAE显着更高（P分别为51.5％和9.9％ <.001）。这主要是由于MAC集团对气道操纵的频繁需求所致。此外，由于气道操作难治的呼吸系统不稳定（n = 8）或明显保留的胃内容物（n = 2），MAC组的10.1％的患者中断了ERCP转换为GEA。两组之间的插管，室内，手术或透视时间在统计学上无显着差异。ERCP完成后，所有接受GEA的患者均已在手术室成功拔管，两组之间的Aldrete康复评分没有差异。没有立即发生不良事件。

结论

对于SREA接受ERCP的高风险患者，GEA镇静与SRAE发生率显着降低有关，而不会影响手术时间，成功率，恢复时间或室内时间。这些数据表明，对于具有高SRAE风险的患者，应将GEA用于ERCP（临床试验注册号：NCT02850887。）。