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Completed

NCT Number: NCT06707077

The Effect of Sevoflurane on Haemodynamics

Cardiac output (CO) is measured using Mostcare. Mean systemic filling pressure (MSFP) and vascular resistances are calculated using venous return curves constructed by measuring steady-state arterial and venous pressures and cardiac output (CO) during inspiratory hold manoeuvres at increasing plateau pressures. Measurements are performed at three incremental levels of targeted sevoflurane concentrations.

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Key information

Age range

3 year–10 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's hospital of Fudan university

Shanghai, China

About this study

Tracheal intubation is performed after anesthesia induction with sevoflurane. Radial arterial is cannulated and pressure transducer is connected to MostCare (core technique PRAM). HR, MAP, CVP, CO, SVR, PPV, and dp/dt are recorded at three incremental levels of targeted sevoflurane concentrations. MSFP and vascular resistances are calculated.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • American Association of Anesthesiologists (ASA)physical status score I-III
  • major elective surgery that dictates the use of invasive hemodynamic monitoring including CVP and continuous arterial blood pressure monitoring.

Exclusion criteria

  • symptomatic peripheral vascular disease or pulmonary disease
  • aberrant cardiovascular anatomy
  • significant valvular regurgitation
  • severe arrhythmia

Treatment and study plan

Primary outcomes

  1. cardiac output

    Time frame: Hemodynamic parameters are recorded after 15 min of equilibration at each sevoflurane concentration.

    Cardiac output is monitored using Mostcare via a radial arterial catheter connected to the pressure transducer.

  2. mean systemic filling pressure

    Time frame: Hemodynamic parameters are recorded after 15 min of equilibration at each sevoflurane concentration.

    Mean systemic filling pressure (MSFP) is calculated using venous return curve constructed by measuring steady-state arterial and venous pressures and CO during inspiratory hold manoeuvres at increasing plateau pressures. The CVP and CO data are fitted by linear regression to define the venous return curve. We define MSFP by extrapolation to zero flow.

  3. vascular resistance

    Time frame: Hemodynamic parameters are recorded after 15 min of equilibration at each sevoflurane concentration.

    Total systemic vascular resistance (Rsys) is calculated as the ratio of the pressure difference between mean Pa and mean CVP and CO. The resistance downstream to MSFP is taken to reflect the resistance to venous return (Rv) and is calculated as the ratio of the pressure difference between MSFP and CVP and CO. Systemic arterial resistance (Ra) is taken to be the difference between systemic and venous resistance.

Secondary outcomes

  1. mean arterial pressure

    Time frame: Hemodynamic parameters are recorded after 15 min of equilibration at each sevoflurane concentration.

    Systemic arterial blood pressure is monitored via a radial arterial catheter connected to a pressure transducer.

  2. central venous pressure

    Time frame: Hemodynamic parameters are recorded after 15 min of equilibration at each sevoflurane concentration.

    CVP is measured with a catheter inserted through the right internal jugular vein.

  3. pulse pressure variation

    Time frame: Hemodynamic parameters are recorded after 15 min of equilibration at each sevoflurane concentration.

    PPV is obtained from Mostcare.

  4. dP/dt

    Time frame: Hemodynamic parameters are recorded after 15 min of equilibration at each sevoflurane concentration.

    dP/dt is obtained from Mostcare.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Registry information

Official study title

The Effect of Sevoflurane on Cardiac Output, Mean Systemic Filling Pressure, and Vascular Resistances in Children

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 27, 2024
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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