Compare the Oncological Benefit of Deep Neuromuscular Block in Gastric Cancer Obesity Patient
Condition: Gastric Cancer; Obesity
MeSH terms: Stomach Neoplasms; Obesity
Study type: Interventional
Phase: Phase 3

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)
    

Detailed description: 
      This study is designed to evaluate the impact of muscle relaxation during laparoscopic
      gastrectomy on oncological benefit, especially with obese patients over BMI 25. This is a
      randomized controlled trial comparing deep NMB with moderate NMB in laparoscopic subtotal
      gastrectomy in obese patients with gastric cancer. The design of the study is blinded (the
      surgical team and the research team are all blinded to the treatment); the attending
      anesthesiologist is not blinded. 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) The patients are assigned to the deep NMB group
           or the moderate NMB group. The clinical research coordinator (CRC) uses a computer
           randomization program to determine the degree of muscle relaxation of each patient.
           Stratified block randomization is used to guarantee even distribution, which means that
           all participating hospitals are assigned moderate or deep NMB randomly in a 1:1 ratio.
           The CRC notifies the anesthesiologist of the degree of muscle relaxation just before the
           operation. Surgeons are blinded to the degree of muscle relaxation: They can enter the
           operating room after the muscle relaxation has been performed. A train-of-four (TOF)
           monitor is placed out of the surgeon's visual field. The anesthesiologist injects
           sugammadex after confirming the absence of the surgeon. The ward staff members who
           evaluate patient outcomes are blinded to the degree of muscle relaxation.
    

Intervention name(s): Sugammadex Sodium
Intervention type(s): Drug
Intervention description(s): 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.
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.
Other intervention name(s): Bridion®, MSD
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment