drugset / Trial / NCT03196791

Compare the Oncological Benefit of Deep Neuromuscular Block in Gastric Cancer Obesity Patient

NCT03196791 ↗

Phase 3 Completed 196 enrolled Korea University Anam Hospital
RandomizedParallel-groupDouble-blindTreatment

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)

Timeline

Start
2017-10-10
Primary completion
2020-08-09
Completion
2020-09-09

Outcome

Missed primary endpoint

paper 44.6 ± 17.5 vs 41.5 ± 16.9, p = 0.239 PMID 35213496 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Sugammadex Other / unclassified 2 mg/kg Intravenous
Subject Sugammadex Other / unclassified 4 mg/kg Intravenous