CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 196 enrolled
Drug / intervention
Sugammadex Sodiumdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03196791
NCT03196791Phase 3Completed
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A Double-blind, Randomized and Controlled Multicenter Prospective Trial to Compare the Oncological Benefit of Deep Neuromuscular Block in Gastric Cancer Obesity Patient

Korea University Anam Hospital·interventional·Posted Jun 23, 2017·Updated Jul 12, 2021

In Brief

A Phase 3 clinical trial evaluating Sugammadex Sodium for Gastric Cancer and Obesity. Completed, enrolled 196 participants across 1 site.

Detailed 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)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastric Cancer, Obesity
CountriesSouth Korea
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedJun 23, 2017
Enrollment StartOct 10, 2017
Primary CompletionAug 9, 2020
Study CompletionSep 9, 2020
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 9.0 years ago

Interventions

Sugammadex Sodiumdrug

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.