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OpenTrials
Completed

NCT Number: NCT02739399

Effects of Phenylephrine on Cardiac Preload

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

AZ Maria Middelares

Ghent, 9000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phenylephrine

Drug

Intravenous administration

Other names: Phenyl

Primary outcomes

  1. Cardiac output

    Time frame: perioperative

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

Secondary outcomes

  1. Pulse Pressure Variation

    Time frame: perioperative

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

  2. End-Tidal CO2

    Time frame: perioperative

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

  3. Arterial Blood Pressure

    Time frame: perioperative

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

  4. central venous pressure

    Time frame: perioperative

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

Sponsors and collaborators

Lead sponsor

Algemeen Ziekenhuis Maria Middelares

Other

Registry information

Official study title

The Dynamic Effects of Phenylephrine on Preload and Cardiac Output in Patients Under General Anaesthesia

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 15, 2016
Registry last updated
Dec 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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