Gastric Cancer, Obesity
Conditions
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.
Interventions
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.
Sponsors
Korea University Anam Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With at Least One Interruption Event | immediately after surgery | Interrupted event by patient movement, coughing, muscle spasm during operation |
| Intraoperative Blood Loss Amount | immediately after the operation | Amount of bleeding during operation |
| 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). |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 88 |
| 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. | 93 |
| Total | 181 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 7 | 3 |
| Overall Study | Withdrawal by Subject | 3 | 2 |
Baseline characteristics
| Characteristic | Deep Neuromuscular Block Group | Moderate Neuromuscular Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 26 Participants | 27 Participants | 53 Participants |
| Age, Categorical Between 18 and 65 years | 62 Participants | 66 Participants | 128 Participants |
| Age, Continuous | 59.5 years STANDARD_DEVIATION 9.6 | 60.0 years STANDARD_DEVIATION 9.9 | 59.8 years STANDARD_DEVIATION 9.7 |
| ASA classification ASA I | 14 Participants | 8 Participants | 22 Participants |
| ASA classification ASA II | 63 Participants | 77 Participants | 140 Participants |
| ASA classification ASA III | 11 Participants | 8 Participants | 19 Participants |
| Body mass index (kg/m^2) | 27.6 Body mass index (kg/m^2) STANDARD_DEVIATION 2.5 | 27.4 Body mass index (kg/m^2) STANDARD_DEVIATION 2.1 | 27.5 Body mass index (kg/m^2) STANDARD_DEVIATION 2.3 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment South Korea | 88 participants | 93 participants | 181 participants |
| Sex: Female, Male Female | 60 Participants | 62 Participants | 122 Participants |
| Sex: Female, Male Male | 28 Participants | 31 Participants | 59 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 98 | 0 / 98 |
| other Total, other adverse events | 0 / 98 | 0 / 98 |
| serious Total, serious adverse events | 0 / 98 | 0 / 98 |
Outcome results
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
Time frame: within 14 days after operation
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Deep Neuromuscular Block Group | Number of Retrieved Lymph Nodes Per Participant | Total number of patients | 44.6 lymph nodes | Standard Deviation 17.5 |
| Deep Neuromuscular Block Group | Number of Retrieved Lymph Nodes Per Participant | The patients with BMI ≥28kg/m^2 | 49.2 lymph nodes | Standard Deviation 18.6 |
| Moderate Neuromuscular Group | Number of Retrieved Lymph Nodes Per Participant | The patients with BMI ≥28kg/m^2 | 39.2 lymph nodes | Standard Deviation 13.3 |
| Moderate Neuromuscular Group | Number of Retrieved Lymph Nodes Per Participant | Total number of patients | 41.5 lymph nodes | Standard Deviation 16.9 |
Secondary
Intraoperative Blood Loss Amount
Amount of bleeding during operation
Time frame: immediately after the operation
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Deep Neuromuscular Block Group | Intraoperative Blood Loss Amount | 77.5 mL |
| Moderate Neuromuscular Group | Intraoperative Blood Loss Amount | 74.2 mL |
Secondary
Number of Participants With at Least One Interruption Event
Interrupted event by patient movement, coughing, muscle spasm during operation
Time frame: immediately after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Deep Neuromuscular Block Group | Number of Participants With at Least One Interruption Event | 19 Participants |
| Moderate Neuromuscular Group | Number of Participants With at Least One Interruption Event | 34 Participants |
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).
Time frame: immediately after the operation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Deep Neuromuscular Block Group | Surgical Rating Score (SRS) | SRS in LN #5 | 4.2 score on a scale | Standard Deviation 1 |
| Deep Neuromuscular Block Group | Surgical Rating Score (SRS) | SRS in supra-pancreatic area | 4.1 score on a scale | Standard Deviation 1 |
| Deep Neuromuscular Block Group | Surgical Rating Score (SRS) | SRS in LN #6 | 4.2 score on a scale | Standard Deviation 0.9 |
| Deep Neuromuscular Block Group | Surgical Rating Score (SRS) | Average SRS from 4 area | 4.2 score on a scale | Standard Deviation 0.9 |
| Deep Neuromuscular Block Group | Surgical Rating Score (SRS) | SRS in LN #4sb | 4.4 score on a scale | Standard Deviation 0.9 |
| Moderate Neuromuscular Group | Surgical Rating Score (SRS) | Average SRS from 4 area | 4.2 score on a scale | Standard Deviation 0.9 |
| Moderate Neuromuscular Group | Surgical Rating Score (SRS) | SRS in LN #4sb | 4.3 score on a scale | Standard Deviation 0.9 |
| Moderate Neuromuscular Group | Surgical Rating Score (SRS) | SRS in LN #5 | 4.1 score on a scale | Standard Deviation 1 |
| Moderate Neuromuscular Group | Surgical Rating Score (SRS) | SRS in LN #6 | 4.2 score on a scale | Standard Deviation 0.9 |
| Moderate Neuromuscular Group | Surgical Rating Score (SRS) | SRS in supra-pancreatic area | 4.0 score on a scale | Standard Deviation 1.1 |