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.
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jun 2019
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2019
CompletedFirst Posted
Study publicly available on registry
March 13, 2019
CompletedStudy Start
First participant enrolled
June 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2020
CompletedOctober 11, 2019
October 1, 2019
1 year
March 11, 2019
October 9, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
pulse pressure variation
the evolution of the pulse pressure variation in a time course of 20 minutes after the start of phenylephrine/norepinephrine administration
perioperative
Secondary Outcomes (8)
mean arterial blood pressure
perioperative
cardiac output
perioperative
stroke volume (variation)
perioperative
heart rate
perioperative
ventilation frequency
perioperative
- +3 more secondary outcomes
Study Arms (2)
phenylephrine
ACTIVE COMPARATORstarts at 15 µg/kg/h phenylephrine and titrated to main a minimal systolic blood pressure of 100 mmHg
norepinephrine
ACTIVE COMPARATORstarts at 1.5 µg/kg/h phenylephrine and titrated to main a minimal systolic blood pressure of 100 mmHg
Interventions
Eligibility Criteria
You may qualify if:
- Adult
- patients scheduled for DIEP flap surgery
You may not qualify if:
- unwilling or unable to grant written informed consent
- contra-indications for phenylephrine or norepinephrine
- cardiac arrhythmia
- no necessity for pharmacological blood pressure management
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
General Hospital Maria Middelares
Ghent, Oost-Vlaanderen, 9000, Belgium
Related Publications (4)
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.
PMID: 29569112BACKGROUNDO'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.
PMID: 24368739BACKGROUNDBeloeil 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. doi: 10.1093/bja/aei259. Epub 2005 Oct 14.
PMID: 16227334BACKGROUNDHengstmann JH, Goronzy J. Pharmacokinetics of 3H-phenylephrine in man. Eur J Clin Pharmacol. 1982;21(4):335-41. doi: 10.1007/BF00637623.
PMID: 7056280BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alain F Kalmar, MD, PhD
Maria Middelares Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Staff Anesthesist
Study Record Dates
First Submitted
March 11, 2019
First Posted
March 13, 2019
Study Start
June 1, 2019
Primary Completion
June 1, 2020
Study Completion
June 15, 2020
Last Updated
October 11, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share