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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
Algemeen Ziekenhuis Maria Middelares
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
April 6, 2016
Last Updated
December 8, 2016
Sponsor
Algemeen Ziekenhuis Maria Middelares
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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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