Clinical trial NCT02739399: Effects of Phenylephrine on Cardiac Preload
Official title: The Dynamic Effects of Phenylephrine on Preload and Cardiac Output in Patients Under General Anaesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Arterial Hypotension
Anaesthesia
Keywords: phenylephrine
alpha mimetics
pulse pressure variation
venous return
Lead sponsor: Algemeen Ziekenhuis Maria Middelares
Sponsor class: OTHER
First posted: 2016-04-15
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cardiac output
timeFrame: perioperative
Secondary outcomes:
measure: Pulse Pressure Variation
timeFrame: perioperative
measure: End-Tidal CO2
timeFrame: perioperative
measure: Arterial Blood Pressure
timeFrame: perioperative
measure: central venous pressure
timeFrame: perioperative
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: AZ Maria Middelares
Study officials:
affiliation: Department of Anaesthesiology and Intensive care medicine, Maria Middelares hospital, Ghent, Belgium
name: Alain F Kalmar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: