Skip to content

Effect of Phenylephrine Versus Norepinephrine on Venous Return

Comparison of the Hemodynamic Effects of Phenylephrine and Norepinephrine in Patients Undergoing Deep Inferior Epigastric Perforator (DIEP) Flap Surgery.

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03872570
Enrollment
40
Registered
2019-03-13
Start date
2019-06-01
Completion date
2020-06-15
Last updated
2019-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arterial Hypotension

Keywords

cardiac output, pulse pressure variation, fluid responsiveness, hemodynamic monitoring

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.

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.

Interventions

DRUGPhenylephrine

intravenous administration

DRUGNorepinephrine

intravenous administration

Sponsors

Algemeen Ziekenhuis Maria Middelares
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
pulse pressure variationperioperativethe evolution of the pulse pressure variation in a time course of 20 minutes after the start of phenylephrine/norepinephrine administration

Secondary

MeasureTime frameDescription
cardiac outputperioperativethe evolution of the cardiac output in a time course of 20 minutes after the start of phenylephrine/norepinephrine administration
stroke volume (variation)perioperativethe evolution of the stroke volume (variation) in a time course of 20 minutes after the start of phenylephrine/norepinephrine administration
heart rateperioperativethe evolution of the heart rate in a time course of 20 minutes after the start of phenylephrine/norepinephrine administration
mean arterial blood pressureperioperativethe evolution of the mean arterial blood pressure in a time course of 20 minutes after the start of phenylephrine/norepinephrine administration
end-tidal CO2perioperativethe evolution of the end-tidal CO2 in a time course of 20 minutes after the start of phenylephrine/norepinephrine administration
tidal volumeperioperativethe evolution of the tidal volume in a time course of 20 minutes after the start of phenylephrine/norepinephrine administration
TAPSEperioperativethe evolution of the tricuspid annular plane systolic excursion in a time course of 20 minutes after the start of phenylephrine/norepinephrine administration
ventilation frequencyperioperativethe evolution of the ventilation frequency in a time course of 20 minutes after the start of phenylephrine/norepinephrine administration

Countries

Belgium

Contacts

Primary ContactAlain F Kalmar, MD, PhD
alain.kalmar@gmail.com+32 246 17 29
Backup ContactSilvie Allaert, MD, PhD
silvie.allaert@azmmsj.be+32 246 17 28

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026