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Effect of Phenylephrine Versus Norepinephrine on Venous Return

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ClinicalTrials.gov Identifier: NCT03872570
Recruitment Status : Recruiting
First Posted : March 13, 2019
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Alain Kalmar, MD, PhD, Algemeen Ziekenhuis Maria Middelares

Brief Summary:

Induction of general anesthesia often induces a decrease in the mean arterial blood pressure (MAP) caused by arterial and venous dilatation. Fluid administration is conventionally used to increase the patient's total blood volume, but is often associated with multiple adverse events such as postoperative edema.

Arterial hypotension can also be treated by vasopressor agents such as norepinephrine and phenylephrine which mainly increase the blood pressure by arterial vasoconstriction.

Compared to phenylephrine, norepinephrine has a shorter half-life (2 - 3 minutes) and improves the MAP by increase in cardiac contractility. In a recent study at our department it was demonstrated that besides arterial vasoconstriction, phenylephrine also improves venous return and cardiac output by venous vasoconstriction.

The aim of this study is to compare the hemodynamic effects of both vasopressor agents in patients undergoing deep inferior epigastric perforators (DIEP) flap surgery. If significant differences between both agents are demonstrated, these findings can provide an important basis for future recommendations.


Condition or disease Intervention/treatment Phase
Arterial Hypotension Drug: Phenylephrine Drug: Norepinephrine Phase 4

Detailed Description:

In consecutive patients scheduled for DIEP flap surgery, all hemodynamic and respiratory variables are recorded electronically for subsequent off line analysis.

A systolic blood pressure of minimal 100 mmHg will be maintained during surgery by optimization of the cardiac preload and titrated norepinephrine (1.5 µg/kg/h) or phenylephrine (15 µg/kg/h) administration. Cardiac preload optimization will be based on pulse pressure variation (PPV) measurement, which is calculated by pulse contour analysis of the radial arterial pressure curve. Following the international goal-directed fluid therapy guidelines, plasmalyte will be administrated if the PPV>11%.

The tricuspid annular plane systolic excursion (TAPSE) will be measured by transthoracic echocardiography (TTE) to evaluate the inotropic effect of norepinephrine and phenylephrine. In addition, TTE will be used to measure the cardiac output to calibrate the PPV measurements.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Comparison of the Hemodynamic Effects of Phenylephrine and Norepinephrine in Patients Undergoing Deep Inferior Epigastric Perforator (DIEP) Flap Surgery.
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 15, 2020


Arm Intervention/treatment
Active Comparator: phenylephrine
starts at 15 µg/kg/h phenylephrine and titrated to main a minimal systolic blood pressure of 100 mmHg
Drug: Phenylephrine
intravenous administration

Active Comparator: norepinephrine
starts at 1.5 µg/kg/h phenylephrine and titrated to main a minimal systolic blood pressure of 100 mmHg
Drug: Norepinephrine
intravenous administration




Primary Outcome Measures :
  1. pulse pressure variation [ Time Frame: perioperative ]
    the evolution of the pulse pressure variation in a time course of 20 minutes after the start of phenylephrine/norepinephrine administration


Secondary Outcome Measures :
  1. mean arterial blood pressure [ Time Frame: perioperative ]
    the evolution of the mean arterial blood pressure in a time course of 20 minutes after the start of phenylephrine/norepinephrine administration

  2. cardiac output [ Time Frame: perioperative ]
    the evolution of the cardiac output in a time course of 20 minutes after the start of phenylephrine/norepinephrine administration

  3. stroke volume (variation) [ Time Frame: perioperative ]
    the evolution of the stroke volume (variation) in a time course of 20 minutes after the start of phenylephrine/norepinephrine administration

  4. heart rate [ Time Frame: perioperative ]
    the evolution of the heart rate in a time course of 20 minutes after the start of phenylephrine/norepinephrine administration

  5. ventilation frequency [ Time Frame: perioperative ]
    the evolution of the ventilation frequency in a time course of 20 minutes after the start of phenylephrine/norepinephrine administration

  6. end-tidal CO2 [ Time Frame: perioperative ]
    the evolution of the end-tidal CO2 in a time course of 20 minutes after the start of phenylephrine/norepinephrine administration

  7. tidal volume [ Time Frame: perioperative ]
    the evolution of the tidal volume in a time course of 20 minutes after the start of phenylephrine/norepinephrine administration

  8. TAPSE [ Time Frame: perioperative ]
    the evolution of the tricuspid annular plane systolic excursion in a time course of 20 minutes after the start of phenylephrine/norepinephrine administration



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult
  • patients scheduled for DIEP flap surgery

Exclusion Criteria:

  • unwilling or unable to grant written informed consent
  • contra-indications for phenylephrine or norepinephrine
  • cardiac arrhythmia
  • no necessity for pharmacological blood pressure management

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): NCT03872570


Contacts
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Contact: Alain F Kalmar, MD, PhD +32 246 17 29 alain.kalmar@gmail.com
Contact: Silvie Allaert, MD, PhD +32 246 17 28 silvie.allaert@azmmsj.be

Locations
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Belgium
General Hospital Maria Middelares Recruiting
Ghent, Oost-Vlaanderen, Belgium, 9000
Contact: Alain F Kalmar, MD, PhD         
Sponsors and Collaborators
Algemeen Ziekenhuis Maria Middelares
Investigators
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Principal Investigator: Alain F Kalmar, MD, PhD Maria Middelares Hospital

Publications:
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Responsible Party: Dr. Alain Kalmar, MD, PhD, Staff Anesthesist, Algemeen Ziekenhuis Maria Middelares
ClinicalTrials.gov Identifier: NCT03872570     History of Changes
Other Study ID Numbers: MMS.2019.008
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Alain Kalmar, MD, PhD, Algemeen Ziekenhuis Maria Middelares:
cardiac output
pulse pressure variation
fluid responsiveness
hemodynamic monitoring
Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases
Phenylephrine
Oxymetazoline
Norepinephrine
Cardiotonic Agents
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
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