Effect of Phenylephrine Versus Norepinephrine on Venous Return
Study Details
Study Description
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 |
|---|---|---|
| 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.
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- pulse pressure variation [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
- mean arterial blood pressure [perioperative]
the evolution of the mean arterial blood pressure in a time course of 20 minutes after the start of phenylephrine/norepinephrine administration
- cardiac output [perioperative]
the evolution of the cardiac output in a time course of 20 minutes after the start of phenylephrine/norepinephrine administration
- stroke volume (variation) [perioperative]
the evolution of the stroke volume (variation) in a time course of 20 minutes after the start of phenylephrine/norepinephrine administration
- heart rate [perioperative]
the evolution of the heart rate in a time course of 20 minutes after the start of phenylephrine/norepinephrine administration
- ventilation frequency [perioperative]
the evolution of the ventilation frequency in a time course of 20 minutes after the start of phenylephrine/norepinephrine administration
- end-tidal CO2 [perioperative]
the evolution of the end-tidal CO2 in a time course of 20 minutes after the start of phenylephrine/norepinephrine administration
- tidal volume [perioperative]
the evolution of the tidal volume in a time course of 20 minutes after the start of phenylephrine/norepinephrine administration
- TAPSE [perioperative]
the evolution of the tricuspid annular plane systolic excursion in a time course of 20 minutes after the start of phenylephrine/norepinephrine administration
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | General Hospital Maria Middelares | Ghent | Oost-Vlaanderen | Belgium | 9000 |
Sponsors and Collaborators
- Algemeen Ziekenhuis Maria Middelares
Investigators
- Principal Investigator: Alain F Kalmar, MD, PhD, Maria Middelares Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- Beloeil H, Mazoit JX, Benhamou D, Duranteau J. Norepinephrine kinetics and dynamics in septic shock and trauma patients. Br J Anaesth. 2005 Dec;95(6):782-8. Epub 2005 Oct 14.
- Hengstmann JH, Goronzy J. Pharmacokinetics of 3H-phenylephrine in man. Eur J Clin Pharmacol. 1982;21(4):335-41.
- Kalmar AF, Allaert S, Pletinckx P, Maes JW, Heerman J, Vos JJ, Struys MMRF, Scheeren TWL. Phenylephrine increases cardiac output by raising cardiac preload in patients with anesthesia induced hypotension. J Clin Monit Comput. 2018 Dec;32(6):969-976. doi: 10.1007/s10877-018-0126-3. Epub 2018 Mar 22.
- O'Connell TD, Jensen BC, Baker AJ, Simpson PC. Cardiac alpha1-adrenergic receptors: novel aspects of expression, signaling mechanisms, physiologic function, and clinical importance. Pharmacol Rev. 2013 Dec 24;66(1):308-33. doi: 10.1124/pr.112.007203. Print 2014. Review.
- MMS.2019.008