Ignite Creation Date:
2024-05-06 @ 10:14 AM
Last Modification Date:
2024-10-26 @ 12:26 PM
Study NCT ID:
NCT03196791
Status:
COMPLETED
Last Update Posted:
2021-07-12
First Post:
2017-06-20
Brief Title:
Compare the Oncological Benefit of Deep Neuromuscular Block in Gastric Cancer Obesity Patient
Sponsor:
Korea University Anam Hospital
Organization:
Korea University Anam Hospital
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 11 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 surgeons 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
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 11 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 surgeons 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None