Compare the Oncological Benefit of Deep Neuromuscular Block in Gastric Cancer Obesity Patient
A Double-blind, Randomized and Controlled Multicenter Prospective Trial to Compare the Oncological Benefit of Deep Neuromuscular Block in Gastric Cancer Obesity Patient
1 other identifier
interventional
196
1 country
1
Brief Summary
This study is designed to evaluate the impact of muscle relaxation during laparoscopic gastrectomy on oncological benefit, especially with obese patients over BMI 25. The primary endpoint is number of harvested lymph node that is critical point regarding quality of surgery in gastric cancer treatment. The secondary endpoint is intraoperative bleeding, surgeons' satisfaction. The patients were randomly assigned to two groups using a computer-generated randomization table : 196 persons
- Deep neuromuscular block group (98persons)
- Moderate neuromuscular group (98persons)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 gastric-cancer
Started Oct 2017
Shorter than P25 for phase_3 gastric-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 20, 2017
CompletedFirst Posted
Study publicly available on registry
June 23, 2017
CompletedStudy Start
First participant enrolled
October 10, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 9, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 9, 2020
CompletedResults Posted
Study results publicly available
July 12, 2021
CompletedJuly 12, 2021
June 1, 2021
2.8 years
June 20, 2017
April 4, 2021
June 20, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Retrieved Lymph Nodes Per Participant
Number of retrieved lymph nodes per participant, which was reported on final pathology report, after completing the laparoscopic surgery
within 14 days after operation
Secondary Outcomes (3)
Surgical Rating Score (SRS)
immediately after the operation
Number of Participants With at Least One Interruption Event
immediately after surgery
Intraoperative Blood Loss Amount
immediately after the operation
Study Arms (2)
Deep neuromuscular block group
EXPERIMENTALSugammadex sodium 4mg/kg/IV after operation
Moderate neuromuscular group
EXPERIMENTALSugammadex sodium 2mg/kg/IV after operation
Interventions
1. INDICATIONS AND USAGE BRIDION® is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery. BRIDION (sugammadex) injection is a sterile, clear, colorless to slightly yellow-brown, non-pyrogenic aqueous solution intended for intravenous infusion. 2. DOSAGE AND ADMINISTRATION BRIDION (sugammadex) injection, for intravenous use, should be administered by trained healthcare providers familiar with the use, actions, characteristics, and complications of neuromuscular blocking agents (NMBA) and neuromuscular block reversal agents.
Eligibility Criteria
You may qualify if:
- Gastric cancer patients with laparoscopic subtotal gastrectomy
- years
- Body mass index(BMI) \> 25kg/m2
- American Society of Anesthesiologists I-III
You may not qualify if:
- American Society of Anesthesiologists Class IV
- End stage renal disease (ESRD) patient
- Patients with allergy to muscle relaxants
- Patients with diseases that may affect muscle relaxation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Korea University Anam Hospital
Seoul, 02841, South Korea
Related Publications (2)
Park SH, Huh H, Choi SI, Kim JH, Jang YJ, Park JM, Kwon OK, Jung MR, Jeong O, Lee CM, Min JS, Kim JJ, An L, Yang KS, Park S, Lee IO; Deep Neuromuscular Block on Oncologic Quality of Laparoscopic Surgery in Obese Gastric Cancer Patients (DEBLOQS_GC) Study Group. Impact of the Deep Neuromuscular Block on Oncologic Quality of Laparoscopic Surgery in Obese Gastric Cancer Patients: A Randomized Clinical Trial. J Am Coll Surg. 2022 Mar 1;234(3):326-339. doi: 10.1097/XCS.0000000000000061.
PMID: 35213496DERIVEDLee Y, Ha D, An L, Jang YJ, Huh H, Lee CM, Kim YH, Kim JH, Park SH, Mok YJ, Lee IO, Kwon OK, Kwak KH, Min JS, Kim EJ, Choi SI, Yi JW, Jeong O, Jung MR, Bae HB, Park JM, Jung YH, Kim JJ, Kim DA, Park S. 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. Medicine (Baltimore). 2018 Dec;97(49):e13424. doi: 10.1097/MD.0000000000013424.
PMID: 30544421DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Shin Hoo Park
- Organization
- Korea university Anam Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Sung soo Park, MD,PhD
Korea University Anam Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 20, 2017
First Posted
June 23, 2017
Study Start
October 10, 2017
Primary Completion
August 9, 2020
Study Completion
September 9, 2020
Last Updated
July 12, 2021
Results First Posted
July 12, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share