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, Sungsoo Park, 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, Sungsoo Park

Abstract

Purpose: Many 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 methods: This 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.

Discussion: This 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 number: ClinicalTrials.gov (NCT03196791), date of registration: October 10, 2017.

Conflict of interest statement

The authors have no conflicts of interest to disclose.

Figures

Figure 1
Figure 1
Overview of the DEBLOQS_GC RCT design. ESRD = end-stage renal disease, DB = deep block, MB = moderate block, RCT = randomized controlled trial.
Figure 2
Figure 2
Visual analogue scale.

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