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

A Pilot Study of the Effects of Nebulized Epoprostenol (Flolan) and Systemic Phenylephrine on Arterial Oxygenation During One Lung Ventilation

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).

Study Overview

• Status: Completed
• Conditions: Oxygenation During One Lung Ventilation
• Intervention / Treatment: Drug: Inhaled Epoprostenol and phenylephrine; Drug: Sevoflurane; Drug: Propofol

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, B3H 1V7
      • Toronto General Hospital, 200 Elizabeth St.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Inhaled Epoprostenol, phenylephrine, sevoflurane; Inhaled Epoprostenol (Flolan), phenylephrine, volatile anesthesia maintenance (Sevoflurane)	Drug: 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; Other Names: Prostacyclin; Drug: Sevoflurane; Volatile maintenance anesthesia
Other: Inhaled Epoprostenol phenylephrine & Propofol; Inhaled Epoprostenol (Flolan), phenylephrine and intravenous anesthesia maintenance (Propofol)	Drug: 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; Other Names: Prostacyclin; Drug: Propofol; Intravenous maintenance anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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 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).
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).

Collaborators and Investigators

• Sponsor: University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): July 30, 2017
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: March 23, 2016
• First Submitted That Met QC Criteria: April 21, 2016
• First Posted (Estimate): April 22, 2016

Study Record Updates

• Last Update Posted (Actual): May 17, 2019
• Last Update Submitted That Met QC Criteria: May 15, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Protective Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Cardiotonic Agents; Hypnotics and Sedatives; Respiratory System Agents; Anesthetics, Inhalation; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Nasal Decongestants; Adrenergic alpha-1 Receptor Agonists; Propofol; Epoprostenol; Sevoflurane; Phenylephrine; Oxymetazoline; Tezosentan
• Other Study ID Numbers: 14-7520

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No