Effects of Phenylephrine on Cardiac Preload
Primary Purpose
Arterial Hypotension, Anaesthesia
Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Phenylephrine
Sponsored by
About this trial
This is an interventional treatment trial for Arterial Hypotension focused on measuring phenylephrine, alpha mimetics, pulse pressure variation, venous return
Eligibility Criteria
Inclusion Criteria:
- Adult
- necessity for arterial blood pressure monitoring
- necessity for central venous blood pressure monitoring
Exclusion Criteria:
- unwilling or unable to grant written informed consent
- cardiac arrythmia
- contra-indication for phenylephrine
- contra-indications for atropine
- contra-indication for Total Intravenous Anesthesia
Sites / Locations
- AZ Maria Middelares
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patient receiving phenylephrine 2ug/kg
Arm Description
phenylephrine 2ug/kg in case of hypotension
Outcomes
Primary Outcome Measures
Cardiac output
The evolution of the Cardiac Output in a time course <20 minutes after administration
Secondary Outcome Measures
Pulse Pressure Variation
The evolution of Pulse Pressure Variation in a time course <20 minutes
End-Tidal CO2
The evolution of the EtCO2-value in a time course <20 minutes
Arterial Blood Pressure
The evolution of The Arterial Blood Pressure in a time course <20 minutes
central venous pressure
The evolution of the central venous pressure in a time course <20 minutes
Full Information
NCT ID
NCT02739399
First Posted
April 6, 2016
Last Updated
December 8, 2016
Sponsor
Algemeen Ziekenhuis Maria Middelares
1. Study Identification
Unique Protocol Identification Number
NCT02739399
Brief Title
Effects of Phenylephrine on Cardiac Preload
Official Title
The Dynamic Effects of Phenylephrine on Preload and Cardiac Output in Patients Under General Anaesthesia
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Algemeen Ziekenhuis Maria Middelares
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In patients under general anesthesia, episodes of hypotension are often treated with phenylephrine. The effect of phenylephrine is conventionally attributed to afterload increase.
The aim of the study is to describe the time course of the effects of phenylephrine on the cardiac preload and cardiac output, and to evaluate whether phenylephrine, as an exclusive alpha-mimetic, could be beneficial for preload optimisation.
Detailed Description
In consecutive patients scheduled for laparoscopic sigmoidectomy, all hemodynamic and respiratory variables are recorded electronically for subsequent offline analysis.
All patients are ventilated in volume control mode with a tidal volume of 8 ml/kg ideal body weight.
During steady-state Target Controlled Infusion (TCI) propofol/remifentanil anesthesia, when the Mean Arterial Blood Pressure (MAP) dropped below 80% of the awake state for at least 5 minutes, a phenylephrine bolus of 2 μg/kg is administered. If necessary this is repeated, or a continuous administration of phenylephrine is started at a rate of 10-30 μg/kg/u.
All patient manipulations during the procedure are electronically recorded and time stamped for subsequent off-line data analysis.
The first episode in each patient where phenylephrine is administered and in a period of at least 10 minutes when minimal or absent patient manipulation occurred, the hemodynamic variables are analysed to describe the effects of phenylephrine administration on the dynamic preload parameters and macro-hemodynamics.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arterial Hypotension, Anaesthesia
Keywords
phenylephrine, alpha mimetics, pulse pressure variation, venous return
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient receiving phenylephrine 2ug/kg
Arm Type
Other
Arm Description
phenylephrine 2ug/kg in case of hypotension
Intervention Type
Drug
Intervention Name(s)
Phenylephrine
Other Intervention Name(s)
Phenyl
Intervention Description
Intravenous administration
Primary Outcome Measure Information:
Title
Cardiac output
Description
The evolution of the Cardiac Output in a time course <20 minutes after administration
Time Frame
perioperative
Secondary Outcome Measure Information:
Title
Pulse Pressure Variation
Description
The evolution of Pulse Pressure Variation in a time course <20 minutes
Time Frame
perioperative
Title
End-Tidal CO2
Description
The evolution of the EtCO2-value in a time course <20 minutes
Time Frame
perioperative
Title
Arterial Blood Pressure
Description
The evolution of The Arterial Blood Pressure in a time course <20 minutes
Time Frame
perioperative
Title
central venous pressure
Description
The evolution of the central venous pressure in a time course <20 minutes
Time Frame
perioperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult
necessity for arterial blood pressure monitoring
necessity for central venous blood pressure monitoring
Exclusion Criteria:
unwilling or unable to grant written informed consent
cardiac arrythmia
contra-indication for phenylephrine
contra-indications for atropine
contra-indication for Total Intravenous Anesthesia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alain F Kalmar, MD, PhD
Organizational Affiliation
Department of Anaesthesiology and Intensive care medicine, Maria Middelares hospital, Ghent, Belgium
Official's Role
Principal Investigator
Facility Information:
Facility Name
AZ Maria Middelares
City
Gent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of Phenylephrine on Cardiac Preload
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