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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dNMB group | Experimental | For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium will be administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever comes first. Then, the infusion rate will be titrated according to PTC (target to keep PTC between 1 to 2). Infusion rate will be 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 will be carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) will be administered at the end of the surgery. Patients will be extubated when the train of four ratio is ≥0.9. |
|
| mNMB group | Active Comparator | For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium will be administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count >2, whichever comes first. Then, the infusion rate will be titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate will be 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) will be administered at the end of the surgery. Patients will be extubated when the train of four ratio is ≥0.9. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rocuronium | Drug | Intravenous infusion rate of rocuronium will be titrated to keep post-tetanic count between 1 to 2. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | intraoperative |
| Arterial to End-tidal Partial Pressure of Carbon Dioxide Difference |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | intraoperative |
| Cardiac Index |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sang-Hyun Hong, MD | Seoul St. Mary's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul St. Mary's Hospital | Seoul | 137-701 | South Korea |
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Subjects were screened and enrolled at Seoul St. Mary's Hospital from July 2014 to January 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Mean | Standard Deviation | ml/cmH2O | intraoperative |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sanghyun Hong | Department of Anesthesiology and Pain Medicine, The Catholic University of Korea College of Medicine, Seoul St. Mary's Hospital | 82-2-2258-2236 | shhong7272@gmail.com |
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| ID | Term |
|---|---|
| D000077123 | Rocuronium |
| ID | Term |
|---|---|
| D000732 | Androstanols |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Rocuronium | Drug | Intravenous infusion rate of rocuronium will be titrated to keep train-of-four count between 1 to 2. |
|
|
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. |
| intraoperative |
| 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. | intraoperative |
| 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. | 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. |
| intraoperative |
| 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) | At completion of pneumoperitoneum surgery |
| 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. | Postoperative 2 days |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | mmHg | intraoperative |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | mmHg | intraoperative |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | % of respiratory dead space | intraoperative |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | % of shunt | intraoperative |
|
|
|
| Other Pre-specified | 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. | Posted | Mean | Standard Deviation | % of mean stroke volume | intraoperative |
|
|
|
| Other Pre-specified | 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. | Posted | Mean | Standard Deviation | L/min/m^2 | intraoperative |
|
|
|
| Other Pre-specified | 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) | Posted | Number | Participants | At completion of pneumoperitoneum surgery |
|
|
|
| Other Pre-specified | 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. | Posted | Mean | Standard Deviation | Scores on a scale | Postoperative 2 days |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | 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. | 0 | 30 | 0 | 30 |
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| D011083 |
| Polycyclic Compounds |
| T Lat+PP2h |
|
| T EndPP |
|
| T Lat+PP2h |
|
| T EndPP |
|
| T Lat+PP2h |
|
| T EndPP |
|
| T Lat+PP2h |
|
| T EndPP |
|
| T Lat+PP2h |
|
| T EndPP |
|
| T Lat+PP2h |
|
| T EndPP |
|
| Acceptable |
|
| Good |
|
| Optimal |
|
| PO 6h |
|
| PO 24h |
|
| PO 48h |
|