Nebulized Epoprostenol (FLOLAN) and Phenylephrine on One Lung Ventilation (OLV)

University Health Network, Toronto

Status and phase: Completed; Phase 4

Conditions: Oxygenation During One Lung Ventilation

Treatments: Drug: Inhaled Epoprostenol and phenylephrine; Drug: Propofol; Drug: Sevoflurane

Study type: Interventional

Funder types: Other

Identifiers

NCT02748265

14-7520

Details and patient eligibility

About

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).

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

Inhaled Epoprostenol, phenylephrine, sevoflurane

Other group

Description:

Inhaled Epoprostenol (Flolan), phenylephrine, volatile anesthesia maintenance (Sevoflurane)

Treatment:

Drug: Sevoflurane

Drug: Inhaled Epoprostenol and phenylephrine

Inhaled Epoprostenol phenylephrine & Propofol

Other group

Description:

Inhaled Epoprostenol (Flolan), phenylephrine and intravenous anesthesia maintenance (Propofol)

Treatment:

Drug: Propofol

Drug: Inhaled Epoprostenol and phenylephrine