The Effect of Sevoflurane on Haemodynamics

NCT06707077 | Completed

• 1 other identifier: HL-002-2024
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sevoflurane; Cardiac Output; Venous Return; Vascular Resistance

Keywords

sevoflurane; cardiac output; mean systemic filling pressure; vascular resistance

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• mean arterial pressure

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

• central venous pressure

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

• pulse pressure variation

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

• dP/dt

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

Study Arms (1)

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.

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children's hospital of Fudan university

Shanghai, China

Location

Study Officials

• Xuan Wang, MD

  Children's Hospital of Fudan University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2024
• First Posted: November 27, 2024
• Study Start: December 5, 2024
• Primary Completion: March 5, 2025
• Study Completion: March 5, 2025
• Last Updated: March 12, 2025

Record last verified: 2025-03

Locations

CN (1)