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NCT Number: NCT03196791

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

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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Key information

Conditions

Gastric Cancer Body Weight Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomach Diseases Stomach Neoplasms

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Korea University Anam Hospital

Seoul, 02841, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sugammadex Sodium

Drug
  • 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 names: Bridion®, MSD

Primary outcomes

  1. Number of Retrieved Lymph Nodes Per Participant

    Time frame: 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 outcomes

  1. Surgical Rating Score (SRS)

    Time frame: 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).

  2. Number of Participants With at Least One Interruption Event

    Time frame: immediately after surgery

    Interrupted event by patient movement, coughing, muscle spasm during operation

  3. Intraoperative Blood Loss Amount

    Time frame: immediately after the operation

    Amount of bleeding during operation

Sponsors and collaborators

Lead sponsor

Korea University Anam Hospital

Other

Registry information

Official study title

A Double-blind, Randomized and Controlled Multicenter Prospective Trial to Compare the Oncological Benefit of Deep Neuromuscular Block in Gastric Cancer Obesity Patient

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jun 23, 2017
Registry last updated
Jul 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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