跳至主要内容
临床试验/NCT02185430
NCT02185430已完成不适用

Effects of Dexmedetomidine on Respiratory Mechanics and Oxygenation During One Lung Ventilation With Chronic Obstructive Lung Disease

Yonsei University0 个研究点目标入组 63 人开始时间: 2014年7月最近更新:
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
入组人数
63
主要终点
The change of the oxygenation

研究概览

简要总结

COPD is often associated with the airflow limitation and the pulmonary hyperinflation. During the one-lung ventilation (OLV), COPD patients' physiologic dead space increases and hypercapnia may develop. In addition, an alveolar overdistention by the pulmonary hyperinflation would divert pulmonary blood flow and impair arterial oxygenation. Dexmedetomidine has both vasoconstricting and vasodilatatory effects on a peripheral vasculature and a smooth muscle but its effects on bronchial smooth muscle is unknown. The investigators will evaluate the effects of dexmedetomidine (bolus of 1.0 μg kg-1 over 10 min followed by a continuous infusion at 0.5 μg kg-1 h-1 infusion during one-lung ventilation) as bronchodilator in COPD patients when administered during surgery with the one lung ventilation. If result successfully shows the effect of dexmedetomidine as a predominantly a vasodilator on bronchial tree, the investigators study can support the dexmedetomidine as a vasodilator for pulmonary vessels and bronchial smooth muscle and as an excellent adjunct to anesthetic agents in COPD patients during the OLV.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Above 40 years of age
  • American Society of Anesthesiologists (ASA) Physical Status I, II, III.
  • COPD diagnosed , criteria ( on preop. PFT : FEV1 < 80%, FEV1 / FVC < 70% after bronchodilator)
  • thoracic surgical procedure

排除标准

  • severe functional liver or kidney disease
  • diagnosed HF ( NYHA class >3)
  • arrhythmia or received treatment with antiarrythmic drug .
  • exceed BMI > 30 kg/ m2
  • bradycardia (HR <50 bpm)

研究组 & 干预措施

Control group

Placebo Comparator

saline solution

干预措施: saline infusion (Drug)

dexmedetomidine group

Active Comparator

dexmedetomidine

干预措施: dexmedetomidine infusion (Drug)

结局指标

主要结局

The change of the oxygenation

时间窗: At two-lung ventilation (T1) , 20 min after of one-lung ventilation (T2), 30 mins after Dex or placebo saline infusion (T3), 60 mins after Dex or placebo saline infusion (T4), at the termination of surgery in TLV (T5)

PaO2/FiO2 ratio

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

相似试验