Cohen Greg S, Kim Kwang-Youn A
Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL 60611, United States.
Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL 60611, United States.
World J Gastrointest Endosc. 2025 May 16;17(5):105031. doi: 10.4253/wjge.v17.i5.105031.
Although the majority of gastrointestinal (GI) endoscopies in the United States are now performed with propofol sedation, a substantial minority are performed with midazolam and fentanyl sedation. Despite the ubiquity of conscious sedation with midazolam and fentanyl in the United States, there is scant evidence specifically supporting the superiority of midazolam plus fentanyl over single agent midazolam sedation in GI endoscopy. We hypothesize that single agent sedation with midazolam is noninferior to sedation with midazolam plus fentanyl in GI endoscopy.
To investigate whether sedation with midazolam alone is noninferior to sedation with midazolam plus fentanyl in GI endoscopy.
We conducted a randomized, single-blind study to compare the safety and effectiveness of single agent midazolam vs. standard fentanyl/midazolam moderate sedation in 300 outpatients presenting for upper endoscopy and/or colonoscopy at a tertiary care hospital. Primary outcomes were patient satisfaction as measured by the previously validated Procedural Sedation Assessment Survey. Secondary outcomes were procedure quality measures and adverse events. Statistical analysis was performed by a biomedical statistician using the test, Fisher's exact test, and Welch's 2-sample -test.
There was no difference in patient satisfaction between sedation groups, as measured by a less than 1 point difference between groups in Procedural Sedation Assessment Survey scores for discomfort during the procedure, and for preference for level of sedation with future procedures. There were no differences in adverse events or procedure quality measures. Cecal intubation time was 1 minute longer in the single agent midazolam group, and an average of 2.7 mg more midazolam was administered when fentanyl was not included in the sedation regimen. The recruitment goal of 772 patients was not reached.
It may be possible to minimize or avoid using fentanyl in endoscopist administered moderate sedation for GI endoscopy. We hope these findings spur further work in this under-researched area.
尽管目前美国大多数胃肠（GI）内镜检查采用丙泊酚镇静，但仍有相当少数采用咪达唑仑和芬太尼镇静。尽管在美国咪达唑仑和芬太尼用于清醒镇静很普遍，但几乎没有证据明确支持在GI内镜检查中咪达唑仑加芬太尼优于单药咪达唑仑镇静。我们假设在GI内镜检查中，单药咪达唑仑镇静不劣于咪达唑仑加芬太尼镇静。
研究在GI内镜检查中，单独使用咪达唑仑镇静是否不劣于咪达唑仑加芬太尼镇静。
我们进行了一项随机、单盲研究，比较单药咪达唑仑与标准芬太尼/咪达唑仑中度镇静在一家三级护理医院接受上消化道内镜检查和/或结肠镜检查的300名门诊患者中的安全性和有效性。主要结局是通过先前验证的程序镇静评估调查测量的患者满意度。次要结局是操作质量指标和不良事件。由生物医学统计学家使用检验、Fisher精确检验和Welch两样本检验进行统计分析。
镇静组之间患者满意度无差异，通过程序镇静评估调查中操作期间不适得分以及对未来操作镇静水平的偏好，两组之间差异小于1分来衡量。不良事件或操作质量指标无差异。单药咪达唑仑组的盲肠插管时间长1分钟，当镇静方案中不包括芬太尼时，咪达唑仑的平均用量多2.7mg。未达到招募772名患者的目标。
在内镜医师实施的GI内镜检查中度镇静中，可能可以尽量减少或避免使用芬太尼。我们希望这些发现能推动在这个研究不足的领域开展进一步的工作。
