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

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ClinicalTrials.gov Identifier: NCT02748265
Recruitment Status : Active, not recruiting
First Posted : April 22, 2016
Last Update Posted : May 4, 2018
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Oxygenation During One Lung Ventilation Drug: Inhaled Epoprostenol and phenylephrine Drug: Sevoflurane Drug: Propofol Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of the Effects of Nebulized Epoprostenol (Flolan) and Systemic Phenylephrine on Arterial Oxygenation During One Lung Ventilation
Study Start Date : March 2016
Actual Primary Completion Date : June 30, 2017
Estimated Study Completion Date : September 2018


Arm Intervention/treatment
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 Name: Prostacyclin

Drug: Sevoflurane
Volatile maintenance anesthesia

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 Name: Prostacyclin

Drug: Propofol
Intravenous maintenance anesthesia




Primary Outcome Measures :
  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 Outcome Measures :
  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). ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02748265


Locations
Canada, Ontario
Toronto General Hospital, 200 Elizabeth St.
Toronto, Ontario, Canada, B3H 1V7
Sponsors and Collaborators
University Health Network, Toronto

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02748265     History of Changes
Other Study ID Numbers: 14-7520
First Posted: April 22, 2016    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Anesthetics
Propofol
Sevoflurane
Epoprostenol
Phenylephrine
Oxymetazoline
Tezosentan
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Cardiotonic Agents
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Sympathomimetics
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Antihypertensive Agents