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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2018-12-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Oxygenation During One Lung Ventilation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Inhaled Epoprostenol, phenylephrine, sevoflurane

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

Group Type OTHER

Inhaled Epoprostenol and phenylephrine

Intervention Type DRUG

After 30 minutes of one-lung ventilation, Epoprostenol 50 ng/kg/min is administered via nebuliser in the anesthesia circuit with phenylephrine administered intravenously

Sevoflurane

Intervention Type DRUG

Volatile maintenance anesthesia

Inhaled Epoprostenol phenylephrine & Propofol

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

Group Type OTHER

Inhaled Epoprostenol and phenylephrine

Intervention Type DRUG

After 30 minutes of one-lung ventilation, Epoprostenol 50 ng/kg/min is administered via nebuliser in the anesthesia circuit with phenylephrine administered intravenously

Propofol

Intervention Type DRUG

Intravenous maintenance anesthesia

Interventions

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Inhaled Epoprostenol and phenylephrine

After 30 minutes of one-lung ventilation, Epoprostenol 50 ng/kg/min is administered via nebuliser in the anesthesia circuit with phenylephrine administered intravenously

Intervention Type DRUG

Sevoflurane

Volatile maintenance anesthesia

Intervention Type DRUG

Propofol

Intravenous maintenance anesthesia

Intervention Type DRUG

Other Intervention Names

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Prostacyclin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No