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临床试验/NCT03576118
NCT03576118已完成不适用

The Effects of Moderate Versus Deep Neuromuscular Block on Respiratory Mechanics and Biotrauma in Patients With Intraoperative Protective Lung Ventilation for Laparoscopy

Ajou University School of Medicine1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2018年11月5日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

Deep neuromuscular relaxation and low pressure pneumoperitoneum

干预措施: Deep neuromuscular block (Drug)

Moderate neuromuscular block

Active Comparator

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

发起方
Ajou University School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jong Yeop Kim

Professor

Ajou University School of Medicine

研究点 (1)

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