Effects of Phenylephrine on Cardiac Preload

Anaesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02739399
• Other study ID #: MM2015.037
• Status: Completed
• Phase: Phase 4
• First received: April 6, 2016
• Last updated: December 8, 2016
• Start date: February 2016
• Est. completion date: September 2016

Study information

• Verified date: December 2016
• Source: Algemeen Ziekenhuis Maria Middelares
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: September 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anaesthesia
• Arterial Hypotension
• Hypotension

Intervention

Drug:
• Phenylephrine
Intravenous administration

Locations

Country	Name	City	State
Belgium	AZ Maria Middelares	Gent

Sponsors (1)

Lead Sponsor	Collaborator
Algemeen Ziekenhuis Maria Middelares

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac output	The evolution of the Cardiac Output in a time course <20 minutes after administration	perioperative	No
Secondary	Pulse Pressure Variation	The evolution of Pulse Pressure Variation in a time course <20 minutes	perioperative	No
Secondary	End-Tidal CO2	The evolution of the EtCO2-value in a time course <20 minutes	perioperative	No
Secondary	Arterial Blood Pressure	The evolution of The Arterial Blood Pressure in a time course <20 minutes	perioperative	No
Secondary	central venous pressure	The evolution of the central venous pressure in a time course <20 minutes	perioperative	No