Effects of Phenylephrine on Cardiac Preload

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

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.

Study Overview

• Status: Completed
• Conditions: Anaesthesia; Arterial Hypotension
• Intervention / Treatment: Drug: Phenylephrine

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 Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Gent, Belgium, 9000
    • AZ Maria Middelares

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Patient receiving phenylephrine 2ug/kg; phenylephrine 2ug/kg in case of hypotension	Drug: Phenylephrine; Intravenous administration; Other Names: Phenyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac output	The evolution of the Cardiac Output in a time course <20 minutes after administration	perioperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulse Pressure Variation	The evolution of Pulse Pressure Variation in a time course <20 minutes	perioperative
End-Tidal CO2	The evolution of the EtCO2-value in a time course <20 minutes	perioperative
Arterial Blood Pressure	The evolution of The Arterial Blood Pressure in a time course <20 minutes	perioperative
central venous pressure	The evolution of the central venous pressure in a time course <20 minutes	perioperative

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (ACTUAL): July 1, 2016
• Study Completion (ACTUAL): September 1, 2016

Study Registration Dates

• First Submitted: April 6, 2016
• First Submitted That Met QC Criteria: April 11, 2016
• First Posted (ESTIMATE): April 15, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): December 9, 2016
• Last Update Submitted That Met QC Criteria: December 8, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: pulse pressure variation; phenylephrine; venous return; alpha mimetics
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Cardiotonic Agents; Respiratory System Agents; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Nasal Decongestants; Adrenergic alpha-1 Receptor Agonists; Phenylephrine; Oxymetazoline
• Other Study ID Numbers: MM2015.037

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO