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Medicine (Baltimore). 2018 Dec;97(49):e13424. doi: 10.1097/MD.0000000000013424.

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.

Author information

1
Department of Surgery.
2
Department of Anesthesiology and Pain Medicine, Korea University College of Medicine, Seoul.
3
Department of Anesthesiology and Pain Medicine, Kyungpook National University Medical Center, Daegu.
4
Department of Anesthesiology and Pain Medicine, Dongnam institute of Radiological & Medical Sciences, Cancer Center, Busan.
5
Department of Anesthesiology and Pain Medicine, Kyung Hee University Hospital at Gangdong, Seoul.
6
Department of Anesthesiology and Pain Medicine, Chonnam National University Hwasoon Hospital, Hwasun.
7
Department of Anesthesiology and Pain Medicine, Chung-Ang University College of Medicine.
8
Department of Anesthesiology and Pain Medicine, Incheon St. Mary's Hospital, The Catholic University of Korea College of Medicine, Incheon, Korea.

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.

PMID:
30544421
PMCID:
PMC6310580
DOI:
10.1097/MD.0000000000013424
[Indexed for MEDLINE]
Free PMC Article

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