Clinical Trials Directory

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

TypeNameDescription
DRUGDeep neuromuscular blockDeep neuromuscular block using high dose rocuronium and 8 mmHg pneumoperitoneum
DRUGModerate neuromuscular blockModerate 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.