The Effects of Moderate Versus Deep Neuromuscular Block on Respiratory Mechanics and Biotrauma in Patients With Intraoperative Protective Lung Ventilation for Laparoscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Change of Cytokine
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA physical status I or II, aged 25 to 80 years, scheduled for laparoscopic surgery with trendelenburg position
排除标准
- •cerebrovascular disease
- •uncontrolled hypertension, asthma, COPD
- •neuromuscular disorder
- •patients who have had abdominal surgery
- •morbid obesity (body mass index > 35 kg/m2)
研究组 & 干预措施
Deep neuromuscular block
Deep neuromuscular relaxation and low pressure pneumoperitoneum
干预措施: Deep neuromuscular block (Drug)
Moderate neuromuscular block
Moderate neuromuscular relaxation and standard pressure pneumoperitoneum
干预措施: Moderate neuromuscular block (Drug)
结局指标
主要结局
Change of Cytokine
时间窗: baseline, end of pneumoperitoneum, 24 hr after surgery
change of IL-6 (pg/ml)
次要结局
未报告次要终点
研究者
Jong Yeop Kim
Professor
Ajou University School of Medicine
