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The purposes of this study is to investigate the effects of moderate vs. deep neuromuscular block on respiratory mechanics and biotrauma in patients with intraoperative protective lung ventilation for laparoscopy.
Mechanical ventilation results in the disruption of the alveolar-capillary barrier and increased permeability, a hallmark of experimental ventilator-induced lung injury. These mechanical forces also induce an increase in the concentrations of inflammatory cytokines.
The benefits of deep neuromuscular blocks for laparoscopic procedures are controversial and most of the studies undertaken have only sought to improve surgical conditions. Theoretically, deep neuromuscular block permits a lower abdominal insufflation pressure, which leads to better respiratory mechanics and gas exchange. The investigators examined the effects of moderate vs. deep neuromuscular block on respiratory mechanics and biotrauma in patients with intraoperative protective lung ventilation for laparoscopy. The investigators hypothesized that deep neuromuscular block (PTC 1 or 2) and low pressure pneumoperitoneum (8 mmHg) would improve respiratory mechanics and reduce inflammatory processes associated with biotrama during mechanical ventilation compared with moderate neuromuscular block (TOF count 1 or 2 ) and standard pressure pneumoperitoneum (12-15 mmHg).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deep neuromuscular block | Experimental | Deep neuromuscular relaxation and low pressure pneumoperitoneum |
|
| Moderate neuromuscular block | Active Comparator | Moderate neuromuscular relaxation and standard pressure pneumoperitoneum |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep neuromuscular block | Drug | Deep neuromuscular block using high dose rocuronium and 8 mmHg pneumoperitoneum |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of Cytokine | change of IL-6 (pg/ml) | baseline, end of pneumoperitoneum, 24 hr after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jong Yeop Kim | Ajou University Hospital, Suwon, Gyeongki-do, Korea, | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ajou University Hospital | Suwon | Gyeonggi-do | 16499 | South Korea |
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| ID | Title | Description |
|---|---|---|
| FG000 | Deep Neuromuscular Block | Deep neuromuscular relaxation and low pressure pneumoperitoneum Deep neuromuscular block: Deep neuromuscular block using high dose rocuronium and 8 mmHg pneumoperitoneum |
| FG001 | Moderate Neuromuscular Block | Moderate neuromuscular relaxation and standard pressure pneumoperitoneum Moderate neuromuscular block: Moderate neuromuscular block using moderate dose rocuronium and 12 mmHg pneumoperitoneum |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Deep Neuromuscular Block | Deep neuromuscular relaxation and low pressure pneumoperitoneum Deep neuromuscular block: Deep neuromuscular block using high dose rocuronium and 8 mmHg pneumoperitoneum |
| BG001 | Moderate Neuromuscular Block |
| 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 | Change of Cytokine | change of IL-6 (pg/ml) | Posted | Mean | Standard Error | pg/ml | baseline, end of pneumoperitoneum, 24 hr after surgery |
|
baseline, end of pneumoperitoneum, 24 hr after surgery
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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 Block | Deep neuromuscular relaxation and low pressure pneumoperitoneum Deep neuromuscular block: Deep neuromuscular block using high dose rocuronium and 8 mmHg pneumoperitoneum |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jong Yeop Kim | Ajou University Hospital | +82312195574 | kjyeop@ajou.ac.kr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 1, 2019 | Mar 28, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011027 | Pneumoperitoneum |
| ID | Term |
|---|---|
| D010532 | Peritoneal Diseases |
| D004066 | Digestive System Diseases |
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| Moderate neuromuscular block | Drug | Moderate neuromuscular block using moderate dose rocuronium and 12-15 mmHg pneumoperitoneum |
|
|
Moderate neuromuscular relaxation and standard pressure pneumoperitoneum Moderate neuromuscular block: Moderate neuromuscular block using moderate dose rocuronium and 12 mmHg pneumoperitoneum |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| 0 |
| 34 |
| EG001 | Moderate Neuromuscular Block | Moderate neuromuscular relaxation and standard pressure pneumoperitoneum Moderate neuromuscular block: Moderate neuromuscular block using moderate dose rocuronium and 12 mmHg pneumoperitoneum | 0 | 33 | 0 | 33 | 0 | 33 |
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