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

• Sponsor: Korea University Anam Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03196791
• Collaborator: (none)
• Enrollment: 196
• Location: 1
• Arms: 2
• Actual Duration (Months): 35
• Patients Per Site Per Month: 5.6

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer; Obesity	Drug: Sugammadex Sodium	Phase 3

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 196 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Oct 10, 2017
• Actual Primary Completion Date: Aug 9, 2020
• Actual Study Completion Date: Sep 9, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Deep neuromuscular block group Sugammadex sodium 4mg/kg/IV after operation	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.; Other Names: Bridion®, MSD
Experimental: Moderate neuromuscular group Sugammadex sodium 2mg/kg/IV after operation	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.; Other Names: Bridion®, MSD

Outcome Measures

Primary Outcome Measures

1. Number of Retrieved Lymph Nodes Per Participant [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 Outcome Measures

1. Surgical Rating Score (SRS) [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 [immediately after surgery]

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

3. Intraoperative Blood Loss Amount [immediately after the operation]

   Amount of bleeding during operation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Korea University Anam Hospital	Seoul		Korea, Republic of	02841

Sponsors and Collaborators

• Korea University Anam Hospital

Investigators

• Principal Investigator: Sung soo Park, MD,PhD, Korea University Anam Hospital

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 8, 2020

More Information

Publications

None provided.

• Responsible Party: Sungsoo Park, Professor, Korea University Anam Hospital
• ClinicalTrials.gov Identifier: NCT03196791
• Other Study ID Numbers: Debloqs_GC
• First Posted: Jun 23, 2017
• Last Update Posted: Jul 12, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Stomach Neoplasms; Obesity

Study Results

Participant Flow

Arm/Group Title	Deep Neuromuscular Block Group	Moderate Neuromuscular Group
Arm/Group Description	Sugammadex sodium 4mg/kg/IV after operation 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.	Sugammadex sodium 2mg/kg/IV after operation 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.
Period Title: Overall Study
STARTED	98	98
COMPLETED	88	93
NOT COMPLETED	10	5

Baseline Characteristics

Arm/Group Title	Deep Neuromuscular Block Group	Moderate Neuromuscular Group	Total
Arm/Group Description	Sugammadex sodium 4mg/kg/IV after operation 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.	Sugammadex sodium 2mg/kg/IV after operation 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.	Total of all reporting groups
Overall Participants	88	93	181
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	62 70.5%	66 71%	128 70.7%
>=65 years	26 29.5%	27 29%	53 29.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59.5 (9.6)	60.0 (9.9)	59.8 (9.7)
Sex: Female, Male (Count of Participants)
Female	60 68.2%	62 66.7%	122 67.4%
Male	28 31.8%	31 33.3%	59 32.6%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
South Korea	88 100%	93 100%	181 100%
Body mass index (kg/m^2) (Body mass index (kg/m^2)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Body mass index (kg/m^2)]	27.6 (2.5)	27.4 (2.1)	27.5 (2.3)
ASA classification (Count of Participants)
ASA I	14 15.9%	8 8.6%	22 12.2%
ASA II	63 71.6%	77 82.8%	140 77.3%
ASA III	11 12.5%	8 8.6%	19 10.5%

Outcome Measures

1. Primary Outcome

Title	Number of Retrieved Lymph Nodes Per Participant
Description	Number of retrieved lymph nodes per participant, which was reported on final pathology report, after completing the laparoscopic surgery
Time Frame	within 14 days after operation

Outcome Measure Data

Analysis Population Description

This study originally intended to analyze whether a deeper depth of NMB can increase the number of retried LNs in obese gastric cancer patients. We tried to find a certain BMI point where the mean number of LNs showed a significant difference depending on the depth of NMB. BMI 28 was the starting point for the difference in the mean number of retrieved LNs.

Arm/Group Title	Deep Neuromuscular Block Group	Moderate Neuromuscular Group
Arm/Group Description	Sugammadex sodium 4mg/kg/IV after operation 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.	Sugammadex sodium 2mg/kg/IV after operation 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.
Measure Participants	88	91
Total number of patients	44.6 (17.5)	41.5 (16.9)
The patients with BMI ≥28kg/m^2	49.2 (18.6)	39.2 (13.3)

2. Secondary Outcome

Title	Surgical Rating Score (SRS)
Description	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).
Time Frame	immediately after the operation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Deep Neuromuscular Block Group	Moderate Neuromuscular Group
Arm/Group Description	Sugammadex sodium 4mg/kg/IV after operation 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.	Sugammadex sodium 2mg/kg/IV after operation 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.
Measure Participants	88	91
SRS in LN #4sb	4.4 (0.9)	4.3 (0.9)
SRS in LN #5	4.2 (1.0)	4.1 (1.0)
SRS in LN #6	4.2 (0.9)	4.2 (0.9)
SRS in supra-pancreatic area	4.1 (1.0)	4.0 (1.1)
Average SRS from 4 area	4.2 (0.9)	4.2 (0.9)

3. Secondary Outcome

Title	Number of Participants With at Least One Interruption Event
Description	Interrupted event by patient movement, coughing, muscle spasm during operation
Time Frame	immediately after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Deep Neuromuscular Block Group	Moderate Neuromuscular Group
Arm/Group Description	Sugammadex sodium 4mg/kg/IV after operation 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.	Sugammadex sodium 2mg/kg/IV after operation 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.
Measure Participants	88	91
Count of Participants [Participants]	19 21.6%	34 36.6%

4. Secondary Outcome

Title	Intraoperative Blood Loss Amount
Description	Amount of bleeding during operation
Time Frame	immediately after the operation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Deep Neuromuscular Block Group	Moderate Neuromuscular Group
Arm/Group Description	Sugammadex sodium 4mg/kg/IV after operation 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.	Sugammadex sodium 2mg/kg/IV after operation 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.
Measure Participants	88	91
Median (Full Range) [mL]	77.5	74.2

Adverse Events

Time Frame	Adverse event within 6 months were reported for every patients during outpatient clinic follow up.
Arm/Group Title	Deep Neuromuscular Block Group		Moderate Neuromuscular Group
Arm/Group Description	Sugammadex sodium 4mg/kg/IV after operation 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.		Sugammadex sodium 2mg/kg/IV after operation 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.
All Cause Mortality
	Deep Neuromuscular Block Group		Moderate Neuromuscular Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/98 (0%)		0/98 (0%)
Serious Adverse Events
	Deep Neuromuscular Block Group		Moderate Neuromuscular Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/98 (0%)		0/98 (0%)
Other (Not Including Serious) Adverse Events
	Deep Neuromuscular Block Group		Moderate Neuromuscular Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/98 (0%)		0/98 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.