Effects of Phenylephrine on Cardiac Preload

Algemeen Ziekenhuis Maria Middelares

Status and phase: Completed; Phase 4

Conditions: Anaesthesia; Arterial Hypotension

Treatments: Drug: Phenylephrine

Study type: Interventional

Funder types: Other

Identifiers

NCT02739399

MM2015.037

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

Patient receiving phenylephrine 2ug/kg

Other group

Description:

phenylephrine 2ug/kg in case of hypotension

Treatment:

Drug: Phenylephrine