Division of Gastroenterology, Department of Internal Medicine, Gachon University, Gil Medical Center, Incheon, Republic of Korea.
Gachon University of Medicine and Science, School of Medicine, Incheon, Republic of Korea.
Endoscopy. 2017 Oct;49(10):949-956. doi: 10.1055/s-0043-112491. Epub 2017 Jun 21.
Anticholinergic premedication has not been validated for endoscopic submucosal dissection (ESD). In this randomized, double-blind, placebo-controlled trial, we investigated the efficacy and safety of glycopyrrolate as a premedication for ESD. A total of 196 patients undergoing ESD at a single tertiary medical center between December 2014 and February 2016 were randomly allocated to receive one of the following two premedications: glycopyrrolate (0.004 mg/kg intramuscularly [IM]) or placebo (2.0 mL normal saline solution IM). All patients received the premedication 30 minutes prior to ESD in a double-blind manner. The endoscopists reported the ease of performing the procedure and the incidence of secretion-induced hypoxemia, cough, and other procedure-related adverse events. Glycopyrrolate and placebo were received by 96 and 100 patients, respectively. ESD was successfully performed in all patients without any serious adverse events related to sedation or ESD. The median visual analog scale for procedure ease was higher in the glycopyrrolate group at 8 (interquartile range [IQR] 7 - 9) vs. 7 (IQR 6 - 8.25); < 0.001. The proportions of patients with secretion-induced hypoxemia (4.4 % vs. 14.3 %; = 0.03) and cough (16.7 % vs. 35.7 %; = 0.005) were lower in the glycopyrrolate group. The use of glycopyrrolate as a premedication for ESD significantly improved the ease of performing the procedure and reduced the incidence of secretion-induced hypoxemia and cough during ESD. Glycopyrrolate may be a promising premedication to ensure safe and stable ESD procedures.
Clinical Research Information Service (CRIS): KCT0001540.
未对内镜黏膜下剥离术（ESD）进行抗胆碱能药物预给药验证。在这项随机、双盲、安慰剂对照试验中，我们研究了格隆溴铵作为 ESD 预给药的疗效和安全性。
2014 年 12 月至 2016 年 2 月，在一家三级医学中心接受 ESD 的 196 例患者被随机分配接受以下两种预给药之一：格隆溴铵（0.004mg/kg 肌内注射 [IM]）或安慰剂（2.0mL 生理盐水溶液 IM）。所有患者均以双盲方式在 ESD 前 30 分钟接受预给药。内镜医生报告了操作的难易程度以及分泌物诱导性低氧血症、咳嗽和其他与操作相关的不良事件的发生率。
分别有 96 例和 100 例患者接受了格隆溴铵和安慰剂。所有患者均成功完成 ESD，无任何与镇静或 ESD 相关的严重不良事件。格隆溴铵组操作简便的中位数视觉模拟量表评分较高，为 8（四分位距 [IQR] 7-9）vs. 7（IQR 6-8.25）；<0.001。分泌物诱导性低氧血症（4.4%vs.14.3%；=0.03）和咳嗽（16.7%vs.35.7%；=0.005）的患者比例较低。
在 ESD 中使用格隆溴铵作为预给药可显著提高操作的简便性，并降低 ESD 期间分泌物诱导性低氧血症和咳嗽的发生率。格隆溴铵可能是一种有前途的预给药药物，可确保安全稳定的 ESD 操作。
临床研究信息服务（CRIS）：KCT0001540。
