Clinical trial NCT03196791: Compare the Oncological Benefit of Deep Neuromuscular Block in Gastric Cancer Obesity Patient
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastric Cancer
Obesity
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
First posted: 2017-06-23
Enrollment: 196
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Retrieved Lymph Nodes Per Participant
timeFrame: within 14 days after operation
Secondary outcomes:
measure: Surgical Rating Score (SRS)
timeFrame: immediately after the operation
measure: Number of Participants With at Least One Interruption Event
timeFrame: immediately after surgery
measure: Intraoperative Blood Loss Amount
timeFrame: immediately after the operation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
Study officials:
affiliation: Korea University Anam Hospital
name: Sung soo Park, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Park SH, Huh H, Choi SI, Kim JH, Jang YJ, Park JM, Kwon OK, Jung MR, Jeong O, Lee CM, Min JS, Kim JJ, An L, Yang KS, Park S, Lee IO; Deep Neuromuscular Block on Oncologic Quality of Laparoscopic Surgery in Obese Gastric Cancer Patients (DEBLOQS_GC) Study Group. Impact of the Deep Neuromuscular Block on Oncologic Quality of Laparoscopic Surgery in Obese Gastric Cancer Patients: A Randomized Clinical Trial. J Am Coll Surg. 2022 Mar 1;234(3):326-339. doi: 10.1097/XCS.0000000000000061.
citation: Lee Y, Ha D, An L, Jang YJ, Huh H, Lee CM, Kim YH, Kim JH, Park SH, Mok YJ, Lee IO, Kwon OK, Kwak KH, Min JS, Kim EJ, Choi SI, Yi JW, Jeong O, Jung MR, Bae HB, Park JM, Jung YH, Kim JJ, Kim DA, Park S. Comparison of oncological benefits of deep neuromuscular block in obese patients with gastric cancer (DEBLOQS_GC study): A study protocol for a double-blind, randomized controlled trial. Medicine (Baltimore). 2018 Dec;97(49):e13424. doi: 10.1097/MD.0000000000013424.