Ikebuchi Yuichiro, Matsumoto Kazuya, Ueda Naoki, Yamashita Taro, Kurumi Hiroki, Onoyama Takumi, Takeda Yohei, Yoshida Akira, Kawaguchi Koichiro, Yashima Kazuo, Fujiwara Kazunori, Imamoto Ryu, Noma Hisashi, Ueki Masaru, Isomoto Hajime
Division of Medicine and Clinical Science, Department of Multidisciplinary Internal Medicine, Faculty of Medicine, Tottori University, Tottori 683-8504, Japan.
Irisawa Medical Clinic, Shimane 690-0025, Japan.
Diagnostics (Basel). 2021 Mar 17;11(3):538. doi: 10.3390/diagnostics11030538.
This randomized trial aimed to compare the safety and efficacy of the GAGLESS mouthpiece for esophagogastroduodenoscopy (EGD) with that of the conventional mouthpiece. In all, 90 participants were divided into the GAGLESS mouthpiece and conventional mouthpiece groups. The primary endpoint was the severity of pain using the visual analog scale (VAS), and secondary endpoints were examination time, past history of endoscopy, success of the procedure, systolic (SBP) and diastolic (DBP) blood pressure, oxygen saturation, pulse rate before and after EGD, and adverse events. Endoscopy was completed in all cases, and no complications were observed. VAS, when passing the scope through the pharynx, was 2.5 ± 2.4 and 2.0 ± 1.9 cm ( = 0.24) in the conventional and GAGLESS groups, respectively, and that, throughout the examination, was 2.5 ± 2.4 and 1.7 ± 1.5 cm ( = 0.06), respectively. The difference in blood pressure between the GAGLESS and conventional groups was not significant for SBP ( = 0.08) and significant for DBP ( = 0.03). The post-EGD difference in DBP was significantly lower in the GAGLESS group than in the conventional group. The results indicate that GAGLESS mouthpieces had a lower VAS during endoscopy than the conventional mouthpieces, and the changes in blood pressure were smaller with the GAGLESS mouthpiece.
这项随机试验旨在比较无 gag 口垫在食管胃十二指肠镜检查（EGD）中的安全性和有效性与传统口垫的安全性和有效性。总共 90 名参与者被分为无 gag 口垫组和传统口垫组。主要终点是使用视觉模拟量表（VAS）评估的疼痛严重程度，次要终点包括检查时间、既往内镜检查史、操作成功率、收缩压（SBP）和舒张压（DBP）、氧饱和度、EGD 前后的脉搏率以及不良事件。所有病例的内镜检查均完成，未观察到并发症。在传统组和无 gag 组中，当内镜通过咽部时，VAS 分别为 2.5±2.4 和 2.0±1.9 cm（P = 0.24），而在整个检查过程中，VAS 分别为 2.5±2.4 和 1.7±1.5 cm（P = 0.06）。无 gag 组和传统组之间的收缩压差异不显著（P = 0.08），舒张压差异显著（P = 0.03）。无 gag 组 EGD 后的舒张压差异显著低于传统组。结果表明，无 gag 口垫在内镜检查期间的 VAS 低于传统口垫，并且使用无 gag 口垫时血压变化较小。
