A Pilot Study of the Effects of Nebulized Epoprostenol (Flolan) and Systemic Phenylephrine on Arterial Oxygenation During One Lung Ventilation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Increase of arterial oxygen tension in mmHg, during one-lung ventilation surgery, in response to combined nebulized epoprostenol/phenylephrine treatment
研究概览
简要总结
This is a pilot study of a new use of Epoprostenol via inhalation (Epoprostenol is approved for intravenous use). The purpose of this study is to administered inhaled Epoprostenol and intravenous Phenylephrine to improve arterial oxygen tension during one-lung anesthesia either with volatile anesthesia (Sevoflurane) or with intravenous anesthesia (Propofol).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing esophagectomy via video assisted thoracoscopy surgery or open thoracotomy.
- •Patients greater than eighteen years old that have the capacity to provide consent.
- •Patients who weigh 89kg or less.
- •Patients with a preoperative platelet count > 100,000mm3
排除标准
- •Contraindication or allergy to any of the study drugs e.g. epoprostenol, phenylephrine, sevoflurane or propofol.
- •Spirometry: Force expiratory Volume (FEV1) less than 80% predicted for age. Patients with spirometry indicative of obstructive lung disease are less likely to develop hypoxemia during OLV compared to patients with normal spirometry . These patients are likely to have a smaller treatment effect if any.
- •A history of a bleeding diathesis.
- •Use of a platelet inhibitor within the last seven days e.g. Aspirin, clopidogrel
研究组 & 干预措施
Inhaled Epoprostenol, phenylephrine, sevoflurane
Inhaled Epoprostenol (Flolan), phenylephrine, volatile anesthesia maintenance (Sevoflurane)
干预措施: Inhaled Epoprostenol and phenylephrine (Drug)
Inhaled Epoprostenol, phenylephrine, sevoflurane
Inhaled Epoprostenol (Flolan), phenylephrine, volatile anesthesia maintenance (Sevoflurane)
干预措施: Sevoflurane (Drug)
Inhaled Epoprostenol phenylephrine & Propofol
Inhaled Epoprostenol (Flolan), phenylephrine and intravenous anesthesia maintenance (Propofol)
干预措施: Inhaled Epoprostenol and phenylephrine (Drug)
Inhaled Epoprostenol phenylephrine & Propofol
Inhaled Epoprostenol (Flolan), phenylephrine and intravenous anesthesia maintenance (Propofol)
干预措施: Propofol (Drug)
结局指标
主要结局
Increase of arterial oxygen tension in mmHg, during one-lung ventilation surgery, in response to combined nebulized epoprostenol/phenylephrine treatment
时间窗: Changes measured during surgery, from start of treatment at 30 minutes after one-lung ventilation (T30) to end of the 30 minutes treatment (T60).
次要结局
- Changes in base status in pH(Changes measured during surgery, from start of treatment at 30 minutes after one-lung ventilation (T30) to end of the 30 minutes treatment (T60).)
- Differences between anesthetic technique -volatile vs. intravenous- in increase of arterial oxygen tension in mmHg, during one-lung ventilation surgery, in response to combined nebulized epoprostenol/phenylephrine treatment(Changes measured during surgery, from start of treatment at 30 minutes after one-lung ventilation (T30) to end of the 30 minutes treatment (T60).)
- Changes in platelet function count(Changes measured during surgery, from start of treatment at 30 minutes after one-lung ventilation (T30) to end of the 30 minutes treatment (T60).)
- Changes in acid status in pH(Changes measured during surgery, from start of treatment at 30 minutes after one-lung ventilation (T30) to end of the 30 minutes treatment (T60).)
- Changes in mean arterial blood pressure in mmHg(Changes measured during surgery, from start of treatment at 30 minutes after one-lung ventilation (T30) to end of the 30 minutes treatment (T60).)