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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

196 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-10

Study Completion Date

2020-09-09

Brief Summary

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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)

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Detailed Description

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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.

Conditions

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Gastric Cancer Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Deep neuromuscular block group

Sugammadex sodium 4mg/kg/IV after operation

Group Type EXPERIMENTAL

Sugammadex Sodium

Intervention Type DRUG

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.

Moderate neuromuscular group

Sugammadex sodium 2mg/kg/IV after operation

Group Type EXPERIMENTAL

Sugammadex Sodium

Intervention Type DRUG

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.

Interventions

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Sugammadex Sodium

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.

Intervention Type DRUG

Other Intervention Names

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Bridion®, MSD

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No