Tetsuya Yoshizaki1,2, Masanori Matsumoto3, Tomoya Sako3, Yuzo Kodama4, Akihiko Okada3. 1. Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine, 7-5-2 Kusunoki-Cho, Chuo-Ku, Kobe, Hyogo, 650-0017, Japan. yoshizak@med.kobe-u.ac.jp. 2. Department of Gastroenterology and Hepatology, Osaka Saiseikai Nakatsu Hospital, Osaka, Japan. yoshizak@med.kobe-u.ac.jp. 3. Department of Gastroenterology and Hepatology, Osaka Saiseikai Nakatsu Hospital, Osaka, Japan. 4. Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine, 7-5-2 Kusunoki-Cho, Chuo-Ku, Kobe, Hyogo, 650-0017, Japan.
Abstract
BACKGROUND: Intraoperative body movements are one of the causes of difficulty in performing esophageal endoscopic submucosal dissection (ESD) under conscious sedation. The use of local anesthetics as local injection materials during ESD may overcome this difficulty. We clinically evaluated the lidocaine injection method (LIM) in the submucosa during esophageal ESD. METHODS: This was a single-center, prospective, double-blind, randomized trial. Patients who underwent esophageal ESD under conscious sedation from June 2018 to May 2021 were included in this study. In the LIM group, lidocaine was used for submucosal injection during ESD; in the control group, ESD was performed without lidocaine. The primary outcome was the presence of body movements. RESULTS: Fifty patients were enrolled and randomized in a 1:1 ratio in two groups. The incidence of body movements was significantly lower in the LIM group (12% [3/25]) than in the control group (48% [12/25]; P = 0.01). The median additional dose of midazolam was 2 mg (interquartile range [IQR]: 0.5-4 mg) in the LIM group and 4 mg (IQR: 3-6 mg) in the control group, which was significantly lower in the LIM group (P < 0.01). The median visual analog scale score for endoscopist satisfaction was 7 (IQR: 5-8) in the LIM group and 5 (IQR: 4-6.5) in the control group, which was significantly higher in the LIM group. CONCLUSIONS: LIM during esophageal ESD reduced body movements while decreasing the level of sedation. Therefore, LIM during esophageal ESD is an option for maintaining good sedation (UMIN000032804).
BACKGROUND: Intraoperative body movements are one of the causes of difficulty in performing esophageal endoscopic submucosal dissection (ESD) under conscious sedation. The use of local anesthetics as local injection materials during ESD may overcome this difficulty. We clinically evaluated the lidocaine injection method (LIM) in the submucosa during esophageal ESD. METHODS: This was a single-center, prospective, double-blind, randomized trial. Patients who underwent esophageal ESD under conscious sedation from June 2018 to May 2021 were included in this study. In the LIM group, lidocaine was used for submucosal injection during ESD; in the control group, ESD was performed without lidocaine. The primary outcome was the presence of body movements. RESULTS: Fifty patients were enrolled and randomized in a 1:1 ratio in two groups. The incidence of body movements was significantly lower in the LIM group (12% [3/25]) than in the control group (48% [12/25]; P = 0.01). The median additional dose of midazolam was 2 mg (interquartile range [IQR]: 0.5-4 mg) in the LIM group and 4 mg (IQR: 3-6 mg) in the control group, which was significantly lower in the LIM group (P < 0.01). The median visual analog scale score for endoscopist satisfaction was 7 (IQR: 5-8) in the LIM group and 5 (IQR: 4-6.5) in the control group, which was significantly higher in the LIM group. CONCLUSIONS: LIM during esophageal ESD reduced body movements while decreasing the level of sedation. Therefore, LIM during esophageal ESD is an option for maintaining good sedation (UMIN000032804).