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Effects of Phenylephrine on Cardiac Preload

NCT ID: NCT02739399

Last Updated: 2016-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2016-09-30

Brief Summary

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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

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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.

Conditions

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Arterial Hypotension Anaesthesia

Keywords

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phenylephrine alpha mimetics pulse pressure variation venous return

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patient receiving phenylephrine 2ug/kg

phenylephrine 2ug/kg in case of hypotension

Group Type OTHER

Phenylephrine

Intervention Type DRUG

Intravenous administration

Interventions

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Phenylephrine

Intravenous administration

Intervention Type DRUG

Other Intervention Names

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Phenyl

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Algemeen Ziekenhuis Maria Middelares

OTHER

Sponsor Role lead

Responsible Party

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Dr. Alain Kalmar, MD, PhD

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alain F Kalmar, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Anaesthesiology and Intensive care medicine, Maria Middelares hospital, Ghent, Belgium

Locations

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AZ Maria Middelares

Ghent, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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MM2015.037

Identifier Type: -

Identifier Source: org_study_id