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Completed

NCT Number: NCT02748265

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

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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Key information

Conditions

Oxygenation During One Lung Ventilation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Toronto General Hospital, 200 Elizabeth St.

Toronto, Ontario, B3H 1V7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inhaled Epoprostenol and phenylephrine

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

Other names: Prostacyclin

Sevoflurane

Drug

Volatile maintenance anesthesia

Propofol

Drug

Intravenous maintenance anesthesia

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Acronym: FLOLAN

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Apr 22, 2016
Registry last updated
May 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.