Clinical trial NCT06707077: The Effect of Sevoflurane on Haemodynamics
Official title: The Effect of Sevoflurane on Cardiac Output, Mean Systemic Filling Pressure, and Vascular Resistances in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sevoflurane
Cardiac Output
Venous Return
Vascular Resistance
Keywords: sevoflurane
cardiac output
mean systemic filling pressure
vascular resistance
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2024-11-27
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: cardiac output
timeFrame: Hemodynamic parameters are recorded after 15 min of equilibration at each sevoflurane concentration.
measure: mean systemic filling pressure
timeFrame: Hemodynamic parameters are recorded after 15 min of equilibration at each sevoflurane concentration.
measure: vascular resistance
timeFrame: Hemodynamic parameters are recorded after 15 min of equilibration at each sevoflurane concentration.
Secondary outcomes:
measure: mean arterial pressure
timeFrame: Hemodynamic parameters are recorded after 15 min of equilibration at each sevoflurane concentration.
measure: central venous pressure
timeFrame: Hemodynamic parameters are recorded after 15 min of equilibration at each sevoflurane concentration.
measure: pulse pressure variation
timeFrame: Hemodynamic parameters are recorded after 15 min of equilibration at each sevoflurane concentration.
measure: dP/dt
timeFrame: Hemodynamic parameters are recorded after 15 min of equilibration at each sevoflurane concentration.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's hospital of Fudan university
Study officials:
affiliation: Children's Hospital of Fudan University
name: Xuan Wang, MD
role: STUDY_CHAIR
References: