Laparoscopic Renal Surgery, Laparoscopy, Muscle Relaxation
Conditions
Keywords
Respiratory mechanics, Respiratory function test, Hemodynamics
Brief summary
The primary objective of the current study is to compare intraoperative respiratory mechanics in patients receiving laparoscopic renal surgery under deep neuromuscular blockade (dNMB) and under moderate neuromuscular blockade (mNMB). In addition, we will compare intraoperative hemodynamics and postoperative pulmonary function between the two groups.
Interventions
Intravenous infusion rate of rocuronium will be titrated to keep post-tetanic count between 1 to 2.
Sponsors
Study design
Eligibility
Inclusion criteria
* ASA I or II patients scheduled to undergo laparoscopic renal surgery
Exclusion criteria
* BMI ≥35 kg/m2 * Known neuromuscular disease * History of chronic obstructive pulmonary disease * Asthma * Pneumothorax * Bronchopleural fistula * Previous lung surgery * Previous retroperitoneal surgery * Hemodynamic instability * History of cardiopulmonary disease * Renal insufficiency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Thoracopulmonary Compliance | intraoperative | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Arterial Oxygen Tension/Inspired Oxygen Fraction | intraoperative | Was calculated from arterial blood oxygen analysis. Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP. |
| Arterial to End-tidal Partial Pressure of Carbon Dioxide Difference | intraoperative | Was 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. |
| Estimated Dead Space | intraoperative | Was 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. |
| Pulmonary Shunt | intraoperative | Was 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cardiac Index | intraoperative | Was 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. |
| Surgical Condition | At completion of pneumoperitoneum surgery | Subjective rating of the view on the operating field was assessed by the surgeon who performed the surgery (optimal condition, good, acceptable, poor, extremely poor) |
| Postoperative Pain | Postoperative 2 days | Postoperative 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. |
| Stroke Volume Variation | intraoperative | Was 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. |
Countries
South Korea
Participant flow
Recruitment details
Subjects were screened and enrolled at Seoul St. Mary's Hospital from July 2014 to January 2015.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| 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. | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Deep Neuromuscular Blockade (Deep NMB) Group | Total | Moderate Neuromuscular Blockade (Moderate NMB) Group |
|---|---|---|---|
| Age, Continuous | 48.3 years STANDARD_DEVIATION 10.7 | 49.1 years STANDARD_DEVIATION 10.8 | 49.8 years STANDARD_DEVIATION 11 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 30 Participants | 60 Participants | 30 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Korea, Republic of | 30 participants | 60 participants | 30 participants |
| Sex: Female, Male Female | 14 Participants | 27 Participants | 13 Participants |
| Sex: Female, Male Male | 16 Participants | 33 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Thoracopulmonary Compliance
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).
Time frame: intraoperative
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Deep Neuromuscular Blockade (Deep NMB) Group | Thoracopulmonary Compliance | T Lateral | 51.9 ml/cmH2O | Standard Deviation 9.8 |
| Deep Neuromuscular Blockade (Deep NMB) Group | Thoracopulmonary Compliance | T Lat+PP2h | 33.6 ml/cmH2O | Standard Deviation 7.7 |
| Deep Neuromuscular Blockade (Deep NMB) Group | Thoracopulmonary Compliance | T Lat+PP1h | 34.6 ml/cmH2O | Standard Deviation 6.8 |
| Deep Neuromuscular Blockade (Deep NMB) Group | Thoracopulmonary Compliance | T EndPP | 54.1 ml/cmH2O | Standard Deviation 11.5 |
| Moderate Neuromuscular Blockade (Moderate NMB) Group | Thoracopulmonary Compliance | T Lat+PP1h | 31.9 ml/cmH2O | Standard Deviation 6.2 |
| Moderate Neuromuscular Blockade (Moderate NMB) Group | Thoracopulmonary Compliance | T Lateral | 52.3 ml/cmH2O | Standard Deviation 11.2 |
| Moderate Neuromuscular Blockade (Moderate NMB) Group | Thoracopulmonary Compliance | T EndPP | 52.6 ml/cmH2O | Standard Deviation 11.7 |
| Moderate Neuromuscular Blockade (Moderate NMB) Group | Thoracopulmonary Compliance | T Lat+PP2h | 30.8 ml/cmH2O | Standard Deviation 6.7 |
Arterial Oxygen Tension/Inspired Oxygen Fraction
Was calculated from arterial blood oxygen analysis. Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP.
Time frame: intraoperative
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Deep Neuromuscular Blockade (Deep NMB) Group | Arterial Oxygen Tension/Inspired Oxygen Fraction | T Lateral | 477 mmHg | Standard Deviation 100 |
| Deep Neuromuscular Blockade (Deep NMB) Group | Arterial Oxygen Tension/Inspired Oxygen Fraction | T Lat+PP1h | 467 mmHg | Standard Deviation 103 |
| Deep Neuromuscular Blockade (Deep NMB) Group | Arterial Oxygen Tension/Inspired Oxygen Fraction | T Lat+PP2h | 468 mmHg | Standard Deviation 86 |
| Deep Neuromuscular Blockade (Deep NMB) Group | Arterial Oxygen Tension/Inspired Oxygen Fraction | T EndPP | 493 mmHg | Standard Deviation 82 |
| Moderate Neuromuscular Blockade (Moderate NMB) Group | Arterial Oxygen Tension/Inspired Oxygen Fraction | T EndPP | 487 mmHg | Standard Deviation 79 |
| Moderate Neuromuscular Blockade (Moderate NMB) Group | Arterial Oxygen Tension/Inspired Oxygen Fraction | T Lateral | 483 mmHg | Standard Deviation 117 |
| Moderate Neuromuscular Blockade (Moderate NMB) Group | Arterial Oxygen Tension/Inspired Oxygen Fraction | T Lat+PP2h | 465 mmHg | Standard Deviation 89 |
| Moderate Neuromuscular Blockade (Moderate NMB) Group | Arterial Oxygen Tension/Inspired Oxygen Fraction | T Lat+PP1h | 461 mmHg | Standard Deviation 90 |
Arterial to End-tidal Partial Pressure of Carbon Dioxide Difference
Was 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.
Time frame: intraoperative
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Deep Neuromuscular Blockade (Deep NMB) Group | Arterial to End-tidal Partial Pressure of Carbon Dioxide Difference | T Lateral | 4.3 mmHg | Standard Deviation 1.7 |
| Deep Neuromuscular Blockade (Deep NMB) Group | Arterial to End-tidal Partial Pressure of Carbon Dioxide Difference | T Lat+PP1h | 5.8 mmHg | Standard Deviation 2.1 |
| Deep Neuromuscular Blockade (Deep NMB) Group | Arterial to End-tidal Partial Pressure of Carbon Dioxide Difference | T Lat+PP2h | 5.8 mmHg | Standard Deviation 2.6 |
| Deep Neuromuscular Blockade (Deep NMB) Group | Arterial to End-tidal Partial Pressure of Carbon Dioxide Difference | T EndPP | 4.2 mmHg | Standard Deviation 2.1 |
| Moderate Neuromuscular Blockade (Moderate NMB) Group | Arterial to End-tidal Partial Pressure of Carbon Dioxide Difference | T EndPP | 5.3 mmHg | Standard Deviation 2.4 |
| Moderate Neuromuscular Blockade (Moderate NMB) Group | Arterial to End-tidal Partial Pressure of Carbon Dioxide Difference | T Lateral | 4.3 mmHg | Standard Deviation 1.4 |
| Moderate Neuromuscular Blockade (Moderate NMB) Group | Arterial to End-tidal Partial Pressure of Carbon Dioxide Difference | T Lat+PP2h | 7.2 mmHg | Standard Deviation 2 |
| Moderate Neuromuscular Blockade (Moderate NMB) Group | Arterial to End-tidal Partial Pressure of Carbon Dioxide Difference | T Lat+PP1h | 7.1 mmHg | Standard Deviation 2.2 |
Estimated Dead Space
Was 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.
Time frame: intraoperative
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Deep Neuromuscular Blockade (Deep NMB) Group | Estimated Dead Space | T Lateral | 11.8 % of respiratory dead space | Standard Deviation 4.6 |
| Deep Neuromuscular Blockade (Deep NMB) Group | Estimated Dead Space | T Lat+PP1h | 14.1 % of respiratory dead space | Standard Deviation 5.1 |
| Deep Neuromuscular Blockade (Deep NMB) Group | Estimated Dead Space | T Lat+PP2h | 14.1 % of respiratory dead space | Standard Deviation 6.1 |
| Deep Neuromuscular Blockade (Deep NMB) Group | Estimated Dead Space | T EndPP | 12.0 % of respiratory dead space | Standard Deviation 5.5 |
| Moderate Neuromuscular Blockade (Moderate NMB) Group | Estimated Dead Space | T EndPP | 14.8 % of respiratory dead space | Standard Deviation 6.2 |
| Moderate Neuromuscular Blockade (Moderate NMB) Group | Estimated Dead Space | T Lateral | 11.9 % of respiratory dead space | Standard Deviation 4 |
| Moderate Neuromuscular Blockade (Moderate NMB) Group | Estimated Dead Space | T Lat+PP2h | 16.4 % of respiratory dead space | Standard Deviation 4 |
| Moderate Neuromuscular Blockade (Moderate NMB) Group | Estimated Dead Space | T Lat+PP1h | 16.5 % of respiratory dead space | Standard Deviation 4.7 |
Pulmonary Shunt
Was 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.
Time frame: intraoperative
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Deep Neuromuscular Blockade (Deep NMB) Group | Pulmonary Shunt | T Lateral | 13.2 % of shunt | Standard Deviation 5.2 |
| Deep Neuromuscular Blockade (Deep NMB) Group | Pulmonary Shunt | T Lat+PP2h | 15.0 % of shunt | Standard Deviation 8.9 |
| Deep Neuromuscular Blockade (Deep NMB) Group | Pulmonary Shunt | T Lat+PP1h | 12.7 % of shunt | Standard Deviation 4.8 |
| Deep Neuromuscular Blockade (Deep NMB) Group | Pulmonary Shunt | T EndPP | 11.9 % of shunt | Standard Deviation 4.9 |
| Moderate Neuromuscular Blockade (Moderate NMB) Group | Pulmonary Shunt | T Lat+PP1h | 13.2 % of shunt | Standard Deviation 6.2 |
| Moderate Neuromuscular Blockade (Moderate NMB) Group | Pulmonary Shunt | T Lateral | 12.4 % of shunt | Standard Deviation 5.7 |
| Moderate Neuromuscular Blockade (Moderate NMB) Group | Pulmonary Shunt | T EndPP | 14.1 % of shunt | Standard Deviation 6.7 |
| Moderate Neuromuscular Blockade (Moderate NMB) Group | Pulmonary Shunt | T Lat+PP2h | 14.8 % of shunt | Standard Deviation 7 |
Cardiac Index
Was 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.
Time frame: intraoperative
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Deep Neuromuscular Blockade (Deep NMB) Group | Cardiac Index | T Lat+PP2h | 2.9 L/min/m^2 | Standard Deviation 0.7 |
| Deep Neuromuscular Blockade (Deep NMB) Group | Cardiac Index | T Lateral | 2.4 L/min/m^2 | Standard Deviation 0.4 |
| Deep Neuromuscular Blockade (Deep NMB) Group | Cardiac Index | T EndPP | 3.0 L/min/m^2 | Standard Deviation 0.8 |
| Deep Neuromuscular Blockade (Deep NMB) Group | Cardiac Index | T Lat+PP1h | 2.8 L/min/m^2 | Standard Deviation 1 |
| Moderate Neuromuscular Blockade (Moderate NMB) Group | Cardiac Index | T EndPP | 3.1 L/min/m^2 | Standard Deviation 0.7 |
| Moderate Neuromuscular Blockade (Moderate NMB) Group | Cardiac Index | T Lat+PP1h | 2.6 L/min/m^2 | Standard Deviation 0.6 |
| Moderate Neuromuscular Blockade (Moderate NMB) Group | Cardiac Index | T Lateral | 2.4 L/min/m^2 | Standard Deviation 0.5 |
| Moderate Neuromuscular Blockade (Moderate NMB) Group | Cardiac Index | T Lat+PP2h | 2.8 L/min/m^2 | Standard Deviation 0.6 |
Postoperative Pain
Postoperative 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.
Time frame: Postoperative 2 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Deep Neuromuscular Blockade (Deep NMB) Group | Postoperative Pain | PO 1h | 5.4 Scores on a scale | Standard Deviation 2 |
| Deep Neuromuscular Blockade (Deep NMB) Group | Postoperative Pain | PO 24h | 2.2 Scores on a scale | Standard Deviation 1.7 |
| Deep Neuromuscular Blockade (Deep NMB) Group | Postoperative Pain | PO 2h | 5.1 Scores on a scale | Standard Deviation 2.1 |
| Deep Neuromuscular Blockade (Deep NMB) Group | Postoperative Pain | PO 48h | 2.2 Scores on a scale | Standard Deviation 1.7 |
| Deep Neuromuscular Blockade (Deep NMB) Group | Postoperative Pain | PO 6h | 4.3 Scores on a scale | Standard Deviation 2.3 |
| Moderate Neuromuscular Blockade (Moderate NMB) Group | Postoperative Pain | PO 48h | 2.4 Scores on a scale | Standard Deviation 1.8 |
| Moderate Neuromuscular Blockade (Moderate NMB) Group | Postoperative Pain | PO 6h | 4.5 Scores on a scale | Standard Deviation 1.8 |
| Moderate Neuromuscular Blockade (Moderate NMB) Group | Postoperative Pain | PO 1h | 5.9 Scores on a scale | Standard Deviation 1.6 |
| Moderate Neuromuscular Blockade (Moderate NMB) Group | Postoperative Pain | PO 2h | 4.9 Scores on a scale | Standard Deviation 1.6 |
| Moderate Neuromuscular Blockade (Moderate NMB) Group | Postoperative Pain | PO 24h | 2.4 Scores on a scale | Standard Deviation 1.8 |
Stroke Volume Variation
Was 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.
Time frame: intraoperative
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Deep Neuromuscular Blockade (Deep NMB) Group | Stroke Volume Variation | T Lateral | 9.2 % of mean stroke volume | Standard Deviation 2 |
| Deep Neuromuscular Blockade (Deep NMB) Group | Stroke Volume Variation | T Lat+PP1h | 11.3 % of mean stroke volume | Standard Deviation 3.3 |
| Deep Neuromuscular Blockade (Deep NMB) Group | Stroke Volume Variation | T Lat+PP2h | 11.4 % of mean stroke volume | Standard Deviation 3.5 |
| Deep Neuromuscular Blockade (Deep NMB) Group | Stroke Volume Variation | T EndPP | 7.3 % of mean stroke volume | Standard Deviation 2.5 |
| Moderate Neuromuscular Blockade (Moderate NMB) Group | Stroke Volume Variation | T EndPP | 7.9 % of mean stroke volume | Standard Deviation 2.6 |
| Moderate Neuromuscular Blockade (Moderate NMB) Group | Stroke Volume Variation | T Lateral | 9.3 % of mean stroke volume | Standard Deviation 1.4 |
| Moderate Neuromuscular Blockade (Moderate NMB) Group | Stroke Volume Variation | T Lat+PP2h | 12.0 % of mean stroke volume | Standard Deviation 2.6 |
| Moderate Neuromuscular Blockade (Moderate NMB) Group | Stroke Volume Variation | T Lat+PP1h | 12.9 % of mean stroke volume | Standard Deviation 3.4 |
Surgical Condition
Subjective rating of the view on the operating field was assessed by the surgeon who performed the surgery (optimal condition, good, acceptable, poor, extremely poor)
Time frame: At completion of pneumoperitoneum surgery
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Deep Neuromuscular Blockade (Deep NMB) Group | Surgical Condition | Poor | 0 Participants |
| Deep Neuromuscular Blockade (Deep NMB) Group | Surgical Condition | Good | 1 Participants |
| Deep Neuromuscular Blockade (Deep NMB) Group | Surgical Condition | Acceptable | 0 Participants |
| Deep Neuromuscular Blockade (Deep NMB) Group | Surgical Condition | Optimal | 29 Participants |
| Deep Neuromuscular Blockade (Deep NMB) Group | Surgical Condition | Extremely poor | 0 Participants |
| Moderate Neuromuscular Blockade (Moderate NMB) Group | Surgical Condition | Optimal | 21 Participants |
| Moderate Neuromuscular Blockade (Moderate NMB) Group | Surgical Condition | Extremely poor | 0 Participants |
| Moderate Neuromuscular Blockade (Moderate NMB) Group | Surgical Condition | Poor | 1 Participants |
| Moderate Neuromuscular Blockade (Moderate NMB) Group | Surgical Condition | Acceptable | 1 Participants |
| Moderate Neuromuscular Blockade (Moderate NMB) Group | Surgical Condition | Good | 7 Participants |