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

Korea University

Status and phase: Completed; Phase 3

Conditions: Gastric Cancer; Obesity

Treatments: Drug: Sugammadex Sodium

Study type: Interventional

Funder types: Other

Identifiers

NCT03196791

Debloqs_GC

Details and patient eligibility

About

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)

Full 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.

Enrollment: 196 patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Gastric cancer patients with laparoscopic subtotal gastrectomy
• 19-75 years
• Body mass index(BMI) > 25kg/m2
• American Society of Anesthesiologists I-III

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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196 participants in 2 patient groups

Deep neuromuscular block group

Experimental group

Description:

Sugammadex sodium 4mg/kg/IV after operation

Treatment:

Drug: Sugammadex Sodium

Moderate neuromuscular group

Experimental group

Description:

Sugammadex sodium 2mg/kg/IV after operation

Treatment:

Drug: Sugammadex Sodium