The Effect of Sevoflurane on Haemodynamics

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

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.

Study Overview

• Status: Completed
• Conditions: Sevoflurane; Vascular Resistance; Cardiac Output; Venous Return

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Children's Hospital of Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The study enrolls patients 3-10 years, with American Association of Anesthesiologists (ASA) physical status score I-III, scheduled for major elective surgery that dictates the use of invasive hemodynamic monitoring including CVP and continuous arterial blood pressure monitoring. Patients with symptomatic peripheral vascular disease or pulmonary disease, aberrant cardiovascular anatomy, significant valvular regurgitation, or severe arrhythmias are excluded.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Exposure; The patient receives three increasing target end-tidal concentrations of sevoflurane, depending on what is hemodynamically (i.e. arterial hypotension) feasible in the individual patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cardiac output	Cardiac output is monitored using Mostcare via a radial arterial catheter connected to the pressure transducer.	Hemodynamic parameters are recorded after 15 min of equilibration at each sevoflurane concentration.
mean systemic filling pressure	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.	Hemodynamic parameters are recorded after 15 min of equilibration at each sevoflurane concentration.
vascular resistance	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.	Hemodynamic parameters are recorded after 15 min of equilibration at each sevoflurane concentration.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean arterial pressure	Systemic arterial blood pressure is monitored via a radial arterial catheter connected to a pressure transducer.	Hemodynamic parameters are recorded after 15 min of equilibration at each sevoflurane concentration.
central venous pressure	CVP is measured with a catheter inserted through the right internal jugular vein.	Hemodynamic parameters are recorded after 15 min of equilibration at each sevoflurane concentration.
pulse pressure variation	PPV is obtained from Mostcare.	Hemodynamic parameters are recorded after 15 min of equilibration at each sevoflurane concentration.
dP/dt	dP/dt is obtained from Mostcare.	Hemodynamic parameters are recorded after 15 min of equilibration at each sevoflurane concentration.

Collaborators and Investigators

• Sponsor: Children's Hospital of Fudan University
• Investigators: Study Chair: Xuan Wang, MD, Children's Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2024
• Primary Completion (Actual): March 5, 2025
• Study Completion (Actual): March 5, 2025

Study Registration Dates

• First Submitted: November 24, 2024
• First Submitted That Met QC Criteria: November 24, 2024
• First Posted (Actual): November 27, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 10, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: sevoflurane; cardiac output; vascular resistance; mean systemic filling pressure
• Other Study ID Numbers: HL-002-2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No