Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, No. 95 Yongan Road, Xicheng District, Beijing, 100050, China.
Beijing Friendship Hospital, Capital Medical University, Beijing, 100050, China.
Trials. 2022 Jun 13;23(1):491. doi: 10.1186/s13063-022-06432-4.
Endoscopic submucosal dissection (ESD) is widely used as an effective treatment of early gastric and esophageal tumors, as it is minimally invasive, safe, and convenient. Epigastric pain is a common complication of ESD. In the traditional cognition, the postoperative pain of ESD is not serious and does not attach too much attention. However, previous studies found that the incidence of moderate to severe pain after ESD can be as high as 44.9~62.8%. At present, there is no unified understanding of how to carry out good postoperative analgesia in patients undergoing ESD of stomach and esophagus. The purpose of present study is to investigate the efficacy of intraoperative dexmedetomidine (DEX) using on postoperative pain though observing the postoperative visual analog scale (VAS) score within 48 h after ESD surgery, so as to explore an effective analgesia and anesthetic method in patients undergoing gastric and esophagus ESD.
METHODS/DESIGN: This study is a prospective, single-center, two-arm, randomized control trail. In total, 120 patients undergoing endoscopic submucosal dissection were stratified by type of surgery (i.e., gastric or esophagus ESD) and randomized into two treatment groups, DEX group (group D, n = 60) and control group (group C, n = 60). Patients in the experimental group (DEX group) will be administrated a loading dose of DEX at 1 μg/kg for 15 min and a continuous infusion at 0.6 μg/kg/h until 30 min before the end of operation. In control group, the same volume of normal saline was infused. The primary outcome is VAS at 2 h after ESD surgery. The secondary outcome will be VAS at 1 h, 4 h, 6 h,18 h, 24 h, and 48 h, the status of perioperative hemodynamics, the use of remedial analgesics, sedation score, shivering, postoperative nausea and vomiting (PONV), and satisfaction scores of patient and complication of ESD (such as bleeding, perforation, aspiration pneumonia).
The results of this study will demonstrate that intraoperative application of DEX is beneficial for postoperative pain treatment in patients undergoing ESD. This study will not only confirm that postoperative pain treatment is necessary for patients undergoing ESD but also provides an effective anesthesia method for postoperative analgesia.
Chinese Clinical Trial Registry, ID: ChiCTR2100043837 , registered on March 4, 2021, http://www.chictr.org.cn .
内镜黏膜下剥离术（ESD）作为一种治疗早期胃和食管肿瘤的有效方法，具有微创、安全、方便的特点。上腹痛是 ESD 的常见并发症。在传统认知中，ESD 术后疼痛并不严重，因此不会过多关注。然而，先前的研究发现，ESD 后中重度疼痛的发生率高达 44.9%~62.8%。目前，对于接受胃和食管 ESD 的患者，如何进行良好的术后镇痛尚没有统一的认识。本研究旨在通过观察 ESD 术后 48 小时内的术后视觉模拟评分（VAS），探讨术中使用右美托咪定（DEX）对内镜黏膜下剥离术患者术后疼痛的疗效，从而探索一种有效的胃和食管 ESD 患者的镇痛和麻醉方法。
方法/设计：这是一项前瞻性、单中心、两臂、随机对照试验。将 120 例接受内镜黏膜下剥离术的患者按手术类型（胃或食管 ESD）分层，随机分为两组，DEX 组（D 组，n=60）和对照组（C 组，n=60）。实验组（DEX 组）患者将给予负荷剂量 1μg/kg 的 DEX 持续输注 15 分钟，然后以 0.6μg/kg/h 的速度持续输注至手术结束前 30 分钟。对照组给予相同容量的生理盐水。主要结局是 ESD 术后 2 小时的 VAS 评分。次要结局将包括 ESD 术后 1 小时、4 小时、6 小时、18 小时、24 小时和 48 小时的 VAS 评分、围手术期血流动力学状态、补救性镇痛药的使用、镇静评分、寒战、术后恶心和呕吐（PONV）以及患者满意度评分和 ESD 并发症（如出血、穿孔、吸入性肺炎）。
本研究结果将表明，术中应用 DEX 有利于 ESD 术后疼痛的治疗。本研究不仅证实了 ESD 术后疼痛治疗的必要性，而且为术后镇痛提供了一种有效的麻醉方法。
中国临床试验注册中心，ID：ChiCTR2100043837，注册于 2021 年 3 月 4 日，http://www.chictr.org.cn。
