A Phase 4 interventional study of Inhaled Epoprostenol and phenylephrine and Sevoflurane in Oxygenation During One Lung Ventilation, sponsored by University Health Network, Toronto. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-17.
Sponsored by University Health Network, Toronto · Phase 4, Interventional, and Treatment
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).
University Health Network, Toronto is the lead sponsor of 1,411 studies on the registry; 292 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Inhaled Epoprostenol (Flolan), phenylephrine, volatile anesthesia maintenance (Sevoflurane)
Drug: Inhaled Epoprostenol and phenylephrine · Drug: Sevoflurane
Inhaled Epoprostenol (Flolan), phenylephrine and intravenous anesthesia maintenance (Propofol)
Drug: Inhaled Epoprostenol and phenylephrine · Drug: Propofol
After 30 minutes of one-lung ventilation, Epoprostenol 50 ng/kg/min is administered via nebuliser in the anesthesia circuit with phenylephrine administered intravenously
Also known as: Prostacyclin
Volatile maintenance anesthesia
Intravenous maintenance anesthesia
Increase of arterial oxygen tension in mmHg, during one-lung ventilation surgery, in response to combined nebulized epoprostenol/phenylephrine treatment
Time frame: 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 base status in pH
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Changes measured during surgery, from start of treatment at 30 minutes after one-lung ventilation (T30) to end of the 30 minutes treatment (T60).
Plan to share: No
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This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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University Health Network, Toronto