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

Phase 3

Completed

Conditions: Gastric Cancer
Obesity

Interventions: Drug: Sugammadex Sodium

Registration Number: NCT03196791

Lead Sponsor: Korea University Anam Hospital

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)

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 196

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Deep neuromuscular block group	Sugammadex Sodium	Sugammadex sodium 4mg/kg/IV after operation
Moderate neuromuscular group	Sugammadex Sodium	Sugammadex sodium 2mg/kg/IV after operation

Primary Outcome Measures

Name	Time	Method
Number of Retrieved Lymph Nodes Per Participant	within 14 days after operation	Number of retrieved lymph nodes per participant, which was reported on final pathology report, after completing the laparoscopic surgery

Secondary Outcome Measures

Name	Time	Method
Surgical Rating Score (SRS)	immediately after the operation	Surgical rating score (SRS) at Four anatomical area during LN dissection During surgery, the surgeon reported the SRS based on the Leiden surgical rating scale (1=extremely poor, 2=poor, 3=acceptable, 4=good, 5=optimal) for each anatomical landmark (LN stations 4sb, 6, and 5 and the suprapancreatic area).
Intraoperative Blood Loss Amount	immediately after the operation	Amount of bleeding during operation
Number of Participants With at Least One Interruption Event	immediately after surgery	Interrupted event by patient movement, coughing, muscle spasm during operation