Trial Outcomes & Findings for Compare the Oncological Benefit of Deep Neuromuscular Block in Gastric Cancer Obesity Patient (NCT NCT03196791)
NCT ID: NCT03196791
Last Updated: 2021-07-12
Results Overview
Number of retrieved lymph nodes per participant, which was reported on final pathology report, after completing the laparoscopic surgery
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
196 participants
Primary outcome timeframe
within 14 days after operation
Results posted on
2021-07-12
Participant Flow
Participant milestones
| Measure |
Deep Neuromuscular Block Group
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.
|
Moderate Neuromuscular Group
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.
|
|---|---|---|
|
Overall Study
STARTED
|
98
|
98
|
|
Overall Study
COMPLETED
|
88
|
93
|
|
Overall Study
NOT COMPLETED
|
10
|
5
|
Reasons for withdrawal
| Measure |
Deep Neuromuscular Block Group
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.
|
Moderate Neuromuscular Group
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.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
7
|
3
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Deep Neuromuscular Block Group
n=88 Participants
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.
|
Moderate Neuromuscular Group
n=93 Participants
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
n=181 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=88 Participants
|
0 Participants
n=93 Participants
|
0 Participants
n=181 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
62 Participants
n=88 Participants
|
66 Participants
n=93 Participants
|
128 Participants
n=181 Participants
|
|
Age, Categorical
>=65 years
|
26 Participants
n=88 Participants
|
27 Participants
n=93 Participants
|
53 Participants
n=181 Participants
|
|
Age, Continuous
|
59.5 years
STANDARD_DEVIATION 9.6 • n=88 Participants
|
60.0 years
STANDARD_DEVIATION 9.9 • n=93 Participants
|
59.8 years
STANDARD_DEVIATION 9.7 • n=181 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=88 Participants
|
62 Participants
n=93 Participants
|
122 Participants
n=181 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=88 Participants
|
31 Participants
n=93 Participants
|
59 Participants
n=181 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
South Korea
|
88 participants
n=88 Participants
|
93 participants
n=93 Participants
|
181 participants
n=181 Participants
|
|
Body mass index (kg/m^2)
|
27.6 Body mass index (kg/m^2)
STANDARD_DEVIATION 2.5 • n=88 Participants
|
27.4 Body mass index (kg/m^2)
STANDARD_DEVIATION 2.1 • n=93 Participants
|
27.5 Body mass index (kg/m^2)
STANDARD_DEVIATION 2.3 • n=181 Participants
|
|
ASA classification
ASA I
|
14 Participants
n=88 Participants
|
8 Participants
n=93 Participants
|
22 Participants
n=181 Participants
|
|
ASA classification
ASA II
|
63 Participants
n=88 Participants
|
77 Participants
n=93 Participants
|
140 Participants
n=181 Participants
|
|
ASA classification
ASA III
|
11 Participants
n=88 Participants
|
8 Participants
n=93 Participants
|
19 Participants
n=181 Participants
|
PRIMARY outcome
Timeframe: within 14 days after operationPopulation: 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.
Number of retrieved lymph nodes per participant, which was reported on final pathology report, after completing the laparoscopic surgery
Outcome measures
| Measure |
Moderate Neuromuscular Group
n=91 Participants
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.
|
Deep Neuromuscular Block Group
n=88 Participants
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.
|
|---|---|---|
|
Number of Retrieved Lymph Nodes Per Participant
Total number of patients
|
41.5 lymph nodes
Standard Deviation 16.9
|
44.6 lymph nodes
Standard Deviation 17.5
|
|
Number of Retrieved Lymph Nodes Per Participant
The patients with BMI ≥28kg/m^2
|
39.2 lymph nodes
Standard Deviation 13.3
|
49.2 lymph nodes
Standard Deviation 18.6
|
SECONDARY outcome
Timeframe: immediately after the operationSurgical 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).
Outcome measures
| Measure |
Moderate Neuromuscular Group
n=91 Participants
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.
|
Deep Neuromuscular Block Group
n=88 Participants
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.
|
|---|---|---|
|
Surgical Rating Score (SRS)
SRS in LN #4sb
|
4.3 score on a scale
Standard Deviation 0.9
|
4.4 score on a scale
Standard Deviation 0.9
|
|
Surgical Rating Score (SRS)
SRS in LN #5
|
4.1 score on a scale
Standard Deviation 1.0
|
4.2 score on a scale
Standard Deviation 1.0
|
|
Surgical Rating Score (SRS)
SRS in LN #6
|
4.2 score on a scale
Standard Deviation 0.9
|
4.2 score on a scale
Standard Deviation 0.9
|
|
Surgical Rating Score (SRS)
SRS in supra-pancreatic area
|
4.0 score on a scale
Standard Deviation 1.1
|
4.1 score on a scale
Standard Deviation 1.0
|
|
Surgical Rating Score (SRS)
Average SRS from 4 area
|
4.2 score on a scale
Standard Deviation 0.9
|
4.2 score on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: immediately after surgeryInterrupted event by patient movement, coughing, muscle spasm during operation
Outcome measures
| Measure |
Moderate Neuromuscular Group
n=91 Participants
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.
|
Deep Neuromuscular Block Group
n=88 Participants
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.
|
|---|---|---|
|
Number of Participants With at Least One Interruption Event
|
34 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: immediately after the operationAmount of bleeding during operation
Outcome measures
| Measure |
Moderate Neuromuscular Group
n=91 Participants
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.
|
Deep Neuromuscular Block Group
n=88 Participants
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.
|
|---|---|---|
|
Intraoperative Blood Loss Amount
|
74.2 mL
Interval 3.0 to 500.0
|
77.5 mL
Interval 3.0 to 540.0
|
Adverse Events
Deep Neuromuscular Block Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Moderate Neuromuscular Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place