Nebulized Epoprostenol (FLOLAN) and Phenylephrine on One Lung Ventilation (OLV)
Phase 4
Completed
- Conditions
- Oxygenation During One Lung Ventilation
- Interventions
- Registration Number
- NCT02748265
- Lead Sponsor
- University Health Network, Toronto
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Inhaled Epoprostenol, phenylephrine, sevoflurane Inhaled Epoprostenol and phenylephrine Inhaled Epoprostenol (Flolan), phenylephrine, volatile anesthesia maintenance (Sevoflurane) Inhaled Epoprostenol phenylephrine & Propofol Inhaled Epoprostenol and phenylephrine Inhaled Epoprostenol (Flolan), phenylephrine and intravenous anesthesia maintenance (Propofol) Inhaled Epoprostenol, phenylephrine, sevoflurane Sevoflurane Inhaled Epoprostenol (Flolan), phenylephrine, volatile anesthesia maintenance (Sevoflurane) Inhaled Epoprostenol phenylephrine & Propofol Propofol Inhaled Epoprostenol (Flolan), phenylephrine and intravenous anesthesia maintenance (Propofol)
- Primary Outcome Measures
Name Time Method 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).
- Secondary Outcome Measures
Name Time Method 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).
Trial Locations
- Locations (1)
Toronto General Hospital, 200 Elizabeth St.
🇨🇦Toronto, Ontario, Canada