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Randomized Controlled Trial Multicenter Study Comparative Study
Comparison of oncological benefits of deep neuromuscular block in obese patients with gastric cancer (DEBLOQS_GC study): A study protocol for a double-blind, randomized controlled trial.
- Yoontaek Lee, Donghwan Ha, Liang An, You-Jin Jang, Hyub Huh, Chang Min Lee, Yeon-Hee Kim, Jong-Han Kim, Seong-Heum Park, Young-Jae Mok, Il Ok Lee, Oh Kyoung Kwon, Kyung Hwa Kwak, Jae Seok Min, Eun Jin Kim, Sung Il Choi, Jae Woo Yi, Oh Jeong, Mi Ran Jung, Hong Bum Bae, Joong-Min Park, Yong Hoon Jung, Jin-Jo Kim, Dal Ah Kim, and Sungsoo Park.
- Department of Surgery.
- Medicine (Baltimore). 2018 Dec 1; 97 (49): e13424e13424.
PurposeMany studies have demonstrated the advantage of maintaining intraoperative deep neuromuscular block (NMB) with sugammadex. This trial is designed to evaluate the impact of muscle relaxation during laparoscopic subtotal gastrectomy on the oncological benefits, particularly in obese patients with gastric cancer.Materials And MethodsThis is a double-blind, randomized controlled multicenter prospective trial. Patients with clinical stage I-II gastric cancer with a body mass index of 25 and over, who undergo laparoscopic subtotal gastrectomy will be eligible for trial inclusion. The patients will be randomized into a deep NMB group or a moderate NMB group with a 1:1 ratio. A total of 196 patients (98 per group) are required. The primary endpoint is the number of harvested lymph nodes, which is a critical index of the quality of surgery in gastric cancer treatment. The secondary endpoints are surgeon's surgical condition score, patient's sedation score, and surgical outcomes including peak inspiratory pressure, operation time, postoperative pain, and morbidity.DiscussionThis is the first study that compares deep NMB with moderate NMB during laparoscopic gastrectomy in obese patients with gastric cancer. We hope to show the oncologic benefits of deep NMB compared with moderate NMB during subtotal gastrectomy.Trial Registration NumberClinicalTrials.gov (NCT03196791), date of registration: October 10, 2017.
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