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Effects of Phenylephrine on Cardiac Preload

Sponsor
Algemeen Ziekenhuis Maria Middelares (Other)
Overall Status
Completed
CT.gov ID
NCT02739399
Collaborator
(none)
26
Enrollment
1
Location
1
Arm
7
Duration (Months)
3.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
26 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Dynamic Effects of Phenylephrine on Preload and Cardiac Output in Patients Under General Anaesthesia
Study Start Date :
Feb 1, 2016
Actual Primary Completion Date :
Jul 1, 2016
Actual Study Completion Date :
Sep 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Other: Patient receiving phenylephrine 2ug/kg

phenylephrine 2ug/kg in case of hypotension

Drug: Phenylephrine
Intravenous administration
Other Names:
  • Phenyl

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Cardiac output [perioperative]

      The evolution of the Cardiac Output in a time course <20 minutes after administration

    Secondary Outcome Measures

    1. Pulse Pressure Variation [perioperative]

      The evolution of Pulse Pressure Variation in a time course <20 minutes

    2. End-Tidal CO2 [perioperative]

      The evolution of the EtCO2-value in a time course <20 minutes

    3. Arterial Blood Pressure [perioperative]

      The evolution of The Arterial Blood Pressure in a time course <20 minutes

    4. central venous pressure [perioperative]

      The evolution of the central venous pressure in a time course <20 minutes

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 AZ Maria Middelares Gent Belgium 9000

    Sponsors and Collaborators

    • Algemeen Ziekenhuis Maria Middelares

    Investigators

    • Principal Investigator: Alain F Kalmar, MD, PhD, Department of Anaesthesiology and Intensive care medicine, Maria Middelares hospital, Ghent, Belgium

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Alain Kalmar, MD, PhD, Dr, Algemeen Ziekenhuis Maria Middelares
    ClinicalTrials.gov Identifier:
    NCT02739399
    Other Study ID Numbers:
    • MM2015.037
    First Posted:
    Apr 15, 2016
    Last Update Posted:
    Dec 9, 2016
    Last Verified:
    Dec 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Dr. Alain Kalmar, MD, PhD, Dr, Algemeen Ziekenhuis Maria Middelares
    phenylephrine
    alpha mimetics
    pulse pressure variation
    venous return
    Additional relevant MeSH terms:
    Hypotension
    Phenylephrine
    Oxymetazoline

    Study Results

    No Results Posted as of Dec 9, 2016