Trials / Completed
CompletedNCT03576118
Moderate vs Deep Neuromuscular Block on Biotrauma During Laparoscopy
The Effects of Moderate Versus Deep Neuromuscular Block on Respiratory Mechanics and Biotrauma in Patients With Intraoperative Protective Lung Ventilation for Laparoscopy
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 74 (actual)
- Sponsor
- Ajou University School of Medicine · Academic / Other
- Sex
- All
- Age
- 25 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Deep neuromuscular block | Deep neuromuscular block using high dose rocuronium and 8 mmHg pneumoperitoneum |
| DRUG | Moderate neuromuscular block | Moderate neuromuscular block using moderate dose rocuronium and 12-15 mmHg pneumoperitoneum |
Timeline
- Start date
- 2018-11-05
- Primary completion
- 2019-07-12
- Completion
- 2019-09-19
- First posted
- 2018-07-03
- Last updated
- 2020-06-11
- Results posted
- 2020-06-11
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT03576118. Inclusion in this directory is not an endorsement.