The Effect of Sevoflurane on Haemodynamics

Completed

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

• Registration Number: NCT06707077
• Lead Sponsor: Children's Hospital of Fudan University

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.

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 Timeline

• Study First Submitted: 2024-11-24
• Study First Submitted QC: 2024-11-24
• Study First Posted: 2024-11-27
• Study Start: 2024-12-05
• Status Verified: 2025-03
• Primary Completion: 2025-03-05
• Study Completion: 2025-03-05
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
cardiac output	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.
mean systemic filling pressure	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.
vascular resistance	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 Outcome Measures

Name	Time	Method
mean arterial pressure	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.
central venous pressure	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.
pulse pressure variation	Hemodynamic parameters are recorded after 15 min of equilibration at each sevoflurane concentration.	PPV is obtained from Mostcare.
dP/dt	Hemodynamic parameters are recorded after 15 min of equilibration at each sevoflurane concentration.	dP/dt is obtained from Mostcare.

Trial Locations

Locations (1)

Children's hospital of Fudan university; 🇨🇳 Shanghai, China