Trial Outcomes & Findings for Effects of Deep Neuromuscular Blockade on Intraoperative Respiratory Mechanics (NCT NCT02185339)
NCT ID: NCT02185339
Last Updated: 2016-07-25
Results Overview
Was measured with a patient spirometry monitor through a flow sensor. Measurements were obtained at the following four time points: (1) 15 min after a patient positioning in lateral decubitus before inducing the pneumoperitoneum (T Lateral); (2) 1 h after pneumoperitoneum induction with the patient in the lateral decubitus position (T Lat+PP1h); (3) 2 h after pneumoperitoneum induction with the patient in the lateral decubitus position (T Lat+PP2h); and (4) at the end of surgery, 15 min after abdominal deflation in the lateral decubitus position (T EndPP).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
61 participants
Primary outcome timeframe
intraoperative
Results posted on
2016-07-25
Participant Flow
Subjects were screened and enrolled at Seoul St. Mary's Hospital from July 2014 to January 2015.
Participant milestones
| Measure |
Deep Neuromuscular Blockade (Deep NMB) Group
For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is \> or \< than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
|
Moderate Neuromuscular Blockade (Moderate NMB) Group
For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is \> or \< than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
31
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Deep Neuromuscular Blockade on Intraoperative Respiratory Mechanics
Baseline characteristics by cohort
| Measure |
Deep Neuromuscular Blockade (Deep NMB) Group
n=30 Participants
For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is \> or \< than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
|
Moderate Neuromuscular Blockade (Moderate NMB) Group
n=30 Participants
For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is \> or \< than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.3 years
STANDARD_DEVIATION 10.7 • n=99 Participants
|
49.8 years
STANDARD_DEVIATION 11.0 • n=107 Participants
|
49.1 years
STANDARD_DEVIATION 10.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
30 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Korea, Republic of
|
30 participants
n=99 Participants
|
30 participants
n=107 Participants
|
60 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: intraoperativeWas measured with a patient spirometry monitor through a flow sensor. Measurements were obtained at the following four time points: (1) 15 min after a patient positioning in lateral decubitus before inducing the pneumoperitoneum (T Lateral); (2) 1 h after pneumoperitoneum induction with the patient in the lateral decubitus position (T Lat+PP1h); (3) 2 h after pneumoperitoneum induction with the patient in the lateral decubitus position (T Lat+PP2h); and (4) at the end of surgery, 15 min after abdominal deflation in the lateral decubitus position (T EndPP).
Outcome measures
| Measure |
Deep Neuromuscular Blockade (Deep NMB) Group
n=30 Participants
For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is \> or \< than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
|
Moderate Neuromuscular Blockade (Moderate NMB) Group
n=30 Participants
For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is \> or \< than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
|
|---|---|---|
|
Thoracopulmonary Compliance
T Lateral
|
51.9 ml/cmH2O
Standard Deviation 9.8
|
52.3 ml/cmH2O
Standard Deviation 11.2
|
|
Thoracopulmonary Compliance
T Lat+PP1h
|
34.6 ml/cmH2O
Standard Deviation 6.8
|
31.9 ml/cmH2O
Standard Deviation 6.2
|
|
Thoracopulmonary Compliance
T Lat+PP2h
|
33.6 ml/cmH2O
Standard Deviation 7.7
|
30.8 ml/cmH2O
Standard Deviation 6.7
|
|
Thoracopulmonary Compliance
T EndPP
|
54.1 ml/cmH2O
Standard Deviation 11.5
|
52.6 ml/cmH2O
Standard Deviation 11.7
|
SECONDARY outcome
Timeframe: intraoperativeWas calculated from arterial blood oxygen analysis. Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP.
Outcome measures
| Measure |
Deep Neuromuscular Blockade (Deep NMB) Group
n=30 Participants
For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is \> or \< than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
|
Moderate Neuromuscular Blockade (Moderate NMB) Group
n=30 Participants
For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is \> or \< than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
|
|---|---|---|
|
Arterial Oxygen Tension/Inspired Oxygen Fraction
T Lateral
|
477 mmHg
Standard Deviation 100
|
483 mmHg
Standard Deviation 117
|
|
Arterial Oxygen Tension/Inspired Oxygen Fraction
T Lat+PP1h
|
467 mmHg
Standard Deviation 103
|
461 mmHg
Standard Deviation 90
|
|
Arterial Oxygen Tension/Inspired Oxygen Fraction
T Lat+PP2h
|
468 mmHg
Standard Deviation 86
|
465 mmHg
Standard Deviation 89
|
|
Arterial Oxygen Tension/Inspired Oxygen Fraction
T EndPP
|
493 mmHg
Standard Deviation 82
|
487 mmHg
Standard Deviation 79
|
SECONDARY outcome
Timeframe: intraoperativeWas calculated from arterial blood and expired carbon dioxide analysis. Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP.
Outcome measures
| Measure |
Deep Neuromuscular Blockade (Deep NMB) Group
n=30 Participants
For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is \> or \< than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
|
Moderate Neuromuscular Blockade (Moderate NMB) Group
n=30 Participants
For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is \> or \< than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
|
|---|---|---|
|
Arterial to End-tidal Partial Pressure of Carbon Dioxide Difference
T Lateral
|
4.3 mmHg
Standard Deviation 1.7
|
4.3 mmHg
Standard Deviation 1.4
|
|
Arterial to End-tidal Partial Pressure of Carbon Dioxide Difference
T Lat+PP1h
|
5.8 mmHg
Standard Deviation 2.1
|
7.1 mmHg
Standard Deviation 2.2
|
|
Arterial to End-tidal Partial Pressure of Carbon Dioxide Difference
T Lat+PP2h
|
5.8 mmHg
Standard Deviation 2.6
|
7.2 mmHg
Standard Deviation 2.0
|
|
Arterial to End-tidal Partial Pressure of Carbon Dioxide Difference
T EndPP
|
4.2 mmHg
Standard Deviation 2.1
|
5.3 mmHg
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: intraoperativeWas calculated from arterial blood and expired carbon dioxide analysis. Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP.
Outcome measures
| Measure |
Deep Neuromuscular Blockade (Deep NMB) Group
n=30 Participants
For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is \> or \< than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
|
Moderate Neuromuscular Blockade (Moderate NMB) Group
n=30 Participants
For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is \> or \< than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
|
|---|---|---|
|
Estimated Dead Space
T Lateral
|
11.8 % of respiratory dead space
Standard Deviation 4.6
|
11.9 % of respiratory dead space
Standard Deviation 4.0
|
|
Estimated Dead Space
T Lat+PP1h
|
14.1 % of respiratory dead space
Standard Deviation 5.1
|
16.5 % of respiratory dead space
Standard Deviation 4.7
|
|
Estimated Dead Space
T Lat+PP2h
|
14.1 % of respiratory dead space
Standard Deviation 6.1
|
16.4 % of respiratory dead space
Standard Deviation 4.0
|
|
Estimated Dead Space
T EndPP
|
12.0 % of respiratory dead space
Standard Deviation 5.5
|
14.8 % of respiratory dead space
Standard Deviation 6.2
|
SECONDARY outcome
Timeframe: intraoperativeWas calculated using the formula: pulmonary shunt = (pulmonary capillary oxygen content - arterial oxygen content) / (pulmonary capillary oxygen content - venous oxygen content). Pulmonary capillary oxygen partial pressure is assumed to be equal to alveolar oxygen partial pressure. Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP.
Outcome measures
| Measure |
Deep Neuromuscular Blockade (Deep NMB) Group
n=30 Participants
For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is \> or \< than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
|
Moderate Neuromuscular Blockade (Moderate NMB) Group
n=30 Participants
For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is \> or \< than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
|
|---|---|---|
|
Pulmonary Shunt
T Lateral
|
13.2 % of shunt
Standard Deviation 5.2
|
12.4 % of shunt
Standard Deviation 5.7
|
|
Pulmonary Shunt
T Lat+PP1h
|
12.7 % of shunt
Standard Deviation 4.8
|
13.2 % of shunt
Standard Deviation 6.2
|
|
Pulmonary Shunt
T Lat+PP2h
|
15.0 % of shunt
Standard Deviation 8.9
|
14.8 % of shunt
Standard Deviation 7.0
|
|
Pulmonary Shunt
T EndPP
|
11.9 % of shunt
Standard Deviation 4.9
|
14.1 % of shunt
Standard Deviation 6.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: intraoperativeWas calculated by taking '(maximum stroke volume - minimum stroke volume) / mean stroke volume' over a respiratory cycle using the FloTrac™ sensor and the Vigileo™ monitor. Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP.
Outcome measures
| Measure |
Deep Neuromuscular Blockade (Deep NMB) Group
n=30 Participants
For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is \> or \< than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
|
Moderate Neuromuscular Blockade (Moderate NMB) Group
n=30 Participants
For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is \> or \< than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
|
|---|---|---|
|
Stroke Volume Variation
T Lateral
|
9.2 % of mean stroke volume
Standard Deviation 2.0
|
9.3 % of mean stroke volume
Standard Deviation 1.4
|
|
Stroke Volume Variation
T Lat+PP1h
|
11.3 % of mean stroke volume
Standard Deviation 3.3
|
12.9 % of mean stroke volume
Standard Deviation 3.4
|
|
Stroke Volume Variation
T Lat+PP2h
|
11.4 % of mean stroke volume
Standard Deviation 3.5
|
12.0 % of mean stroke volume
Standard Deviation 2.6
|
|
Stroke Volume Variation
T EndPP
|
7.3 % of mean stroke volume
Standard Deviation 2.5
|
7.9 % of mean stroke volume
Standard Deviation 2.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: intraoperativeWas obtained from arterial pressure waveform analysis using the FloTrac™ sensor and the Vigileo™ monitor. Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP.
Outcome measures
| Measure |
Deep Neuromuscular Blockade (Deep NMB) Group
n=30 Participants
For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is \> or \< than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
|
Moderate Neuromuscular Blockade (Moderate NMB) Group
n=30 Participants
For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is \> or \< than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
|
|---|---|---|
|
Cardiac Index
T Lateral
|
2.4 L/min/m^2
Standard Deviation 0.4
|
2.4 L/min/m^2
Standard Deviation 0.5
|
|
Cardiac Index
T Lat+PP1h
|
2.8 L/min/m^2
Standard Deviation 1.0
|
2.6 L/min/m^2
Standard Deviation 0.6
|
|
Cardiac Index
T Lat+PP2h
|
2.9 L/min/m^2
Standard Deviation 0.7
|
2.8 L/min/m^2
Standard Deviation 0.6
|
|
Cardiac Index
T EndPP
|
3.0 L/min/m^2
Standard Deviation 0.8
|
3.1 L/min/m^2
Standard Deviation 0.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At completion of pneumoperitoneum surgerySubjective rating of the view on the operating field was assessed by the surgeon who performed the surgery (optimal condition, good, acceptable, poor, extremely poor)
Outcome measures
| Measure |
Deep Neuromuscular Blockade (Deep NMB) Group
n=30 Participants
For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is \> or \< than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
|
Moderate Neuromuscular Blockade (Moderate NMB) Group
n=30 Participants
For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is \> or \< than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
|
|---|---|---|
|
Surgical Condition
Extremely poor
|
0 Participants
|
0 Participants
|
|
Surgical Condition
Poor
|
0 Participants
|
1 Participants
|
|
Surgical Condition
Acceptable
|
0 Participants
|
1 Participants
|
|
Surgical Condition
Good
|
1 Participants
|
7 Participants
|
|
Surgical Condition
Optimal
|
29 Participants
|
21 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Postoperative 2 daysPostoperative pain was measured by Visual Analogue Scale (VAS). Participants were asked to report their level of pain by pointing to a horizontal line, 10 cm in length. The scale (0-10 scores) was anchored by "no pain" (score of 0) and "pain as bad as it could be" (score of 10). Measurements were made at postoperative (PO) 1h, PO 2h, PO 6h, PO 24h, and PO 48h.
Outcome measures
| Measure |
Deep Neuromuscular Blockade (Deep NMB) Group
n=30 Participants
For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is \> or \< than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
|
Moderate Neuromuscular Blockade (Moderate NMB) Group
n=30 Participants
For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is \> or \< than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
|
|---|---|---|
|
Postoperative Pain
PO 1h
|
5.4 Scores on a scale
Standard Deviation 2.0
|
5.9 Scores on a scale
Standard Deviation 1.6
|
|
Postoperative Pain
PO 2h
|
5.1 Scores on a scale
Standard Deviation 2.1
|
4.9 Scores on a scale
Standard Deviation 1.6
|
|
Postoperative Pain
PO 6h
|
4.3 Scores on a scale
Standard Deviation 2.3
|
4.5 Scores on a scale
Standard Deviation 1.8
|
|
Postoperative Pain
PO 24h
|
2.2 Scores on a scale
Standard Deviation 1.7
|
2.4 Scores on a scale
Standard Deviation 1.8
|
|
Postoperative Pain
PO 48h
|
2.2 Scores on a scale
Standard Deviation 1.7
|
2.4 Scores on a scale
Standard Deviation 1.8
|
Adverse Events
Deep Neuromuscular Blockade (Deep NMB) Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Moderate Neuromuscular Blockade (Moderate NMB) 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
Dr. Sanghyun Hong
Department of Anesthesiology and Pain Medicine, The Catholic University of Korea College of Medicine, Seoul St. Mary's Hospital
Phone: 82-2-2258-2236
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place