Effects of Phenylephrine on Cardiac Preload

Phase 4

Completed

• Conditions: Anaesthesia; Arterial Hypotension
• Interventions: Drug: Phenylephrine

• Registration Number: NCT02739399
• Lead Sponsor: Algemeen Ziekenhuis Maria Middelares

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.

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 Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-04-06
• Study First Submitted QC: 2016-04-11
• Study First Posted: 2016-04-15
• Primary Completion: 2016-07
• Study Completion: 2016-09
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-08
• Last Update Posted: 2016-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient receiving phenylephrine 2ug/kg	Phenylephrine	phenylephrine 2ug/kg in case of hypotension

Primary Outcome Measures

Name	Time	Method
Cardiac output	perioperative	The evolution of the Cardiac Output in a time course \<20 minutes after administration

Secondary Outcome Measures

Name	Time	Method
Pulse Pressure Variation	perioperative	The evolution of Pulse Pressure Variation in a time course \<20 minutes
End-Tidal CO2	perioperative	The evolution of the EtCO2-value in a time course \<20 minutes
Arterial Blood Pressure	perioperative	The evolution of The Arterial Blood Pressure in a time course \<20 minutes
central venous pressure	perioperative	The evolution of the central venous pressure in a time course \<20 minutes

Trial Locations

Locations (1)

AZ Maria Middelares; 🇧🇪 Gent, Belgium