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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03196791
• Other study ID #: Debloqs_GC
• Status: Completed
• Phase: Phase 3
• Start date: October 10, 2017
• Est. completion date: September 9, 2020

Study information

• Verified date: June 2021
• Source: Korea University Anam Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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 information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: September 9, 2020
• Est. primary completion date: August 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Obesity
• Stomach Neoplasms

Intervention

Drug:
• Sugammadex Sodium
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.

Locations

Country	Name	City	State
Korea, Republic of	Korea University Anam Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korea University Anam Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Retrieved Lymph Nodes Per Participant	Number of retrieved lymph nodes per participant, which was reported on final pathology report, after completing the laparoscopic surgery	within 14 days after operation
Secondary	Surgical Rating Score (SRS)	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).	immediately after the operation
Secondary	Number of Participants With at Least One Interruption Event	Interrupted event by patient movement, coughing, muscle spasm during operation	immediately after surgery
Secondary	Intraoperative Blood Loss Amount	Amount of bleeding during operation	immediately after the operation