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Remimazolam and Propofol on the Left Ventricular Strain During Anesthesia Induction for Non-cardiac Surgery

The Impact of Remimazolam and Propofol on the Left Ventricular Systolic Performance During Anesthesia-induction for Non-cardiac Surgery: a Speckle Tracking Analysis of the Left Ventricular Strain Using Transthoracic Echocardiography

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05412914
Enrollment
40
Registered
2022-06-09
Start date
2023-01-26
Completion date
2024-01-01
Last updated
2023-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Procedure, Unspecified

Brief summary

This study to compare the impacts of remimazolam or propofol on the left ventricular global longitudinal strain (LV-GLS) during anesthesia induction for non-cardiac surgery. LV-GLS is analyzed by using speckle tracking technique of transthoracic echocardiography.

Detailed description

This study to compare the impacts of remimazolam or propofol on the left ventricular global longitudinal strain (LV-GLS) during anesthesia induction for non-cardiac surgery (n=40). Remimazolam or propofol is randomly administered for anesthesia induction (Group-R and Group-P, respectively) The changes of LV-GLS are analyzed by using using speckle tracking technique. For this study, 2-dimensional of transthoracic echocardiography LV images (apical 2-chamber, 3-chamber, and 4-chamber views) are recorded and stored before administration of remimazolam/propofol (T0), 2 minutes after the administration (T2), 4 minutes after the administration (T4), and 6 minutes after the administration (T6). After the completion of the study, LV-GLS values at T0, T2, T4 and T6 are determined by the off-line analyses of the recorded and stored 2D-images. For the off-line determination of LV-GLS, an automated software of speckle-tracking technique (Qapp Autostrain-LV™, Philips) is employed. The primary measure: Inter-group comparison of the lowest LV-GLS value out of LV-GLS values at T2, T4, and T6. The secondary measures: Inter-group comparisons of the LV-GLS values at T0, T2, T4 and T8. Intra-group comparisons of the LV-GLS value at T0 vs. those at T2, T4 and T8

Interventions

DRUGRemimazolam infusion

Remimazolam infusion for anesthesia induction

Propofol infusion for anesthesia induction

Sponsors

Konkuk University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* left ventricular ejection fraction\> 50% * no left ventricular regional wall motion abnormality

Exclusion criteria

* atrial fibrillation * unfavorable airway * hypotension requiring inotropic support

Design outcomes

Primary

MeasureTime frameDescription
the averaged longitudinal strain of the left ventricle (%)2.5 minutesinter-group comparisons of the lowest values of the longitudinal strains of the left ventricle in the transthoracic echocardiography after administering remimazolam- or propofol-administration for anesthesia induction

Secondary

MeasureTime frameDescription
the longitudinal strain of the left ventricle in apical long-axis view (%)2.5 minutesinter-group comparisons of the longitudinal strains of the left ventricle in apical long-xis view of the transthoracic echocardiography after administering remimazolam- or propofol-administration for anesthesia induction
the longitudinal strain of the left ventricle in apical 2 chamber view (%)2.5 minutesinter-group comparisons of the longitudinal strains of the left ventricle in apical 2 chamber view of the transthoracic echocardiography after administering remimazolam- or propofol-administration for anesthesia induction
the longitudinal strain of the left ventricle in apical 4 chamber view (%)2.5 minutesinter-group comparisons of the longitudinal strains of the left ventricle in apical 4 chamber view of the transthoracic echocardiography after administering remimazolam- or propofol-administration for anesthesia induction
the election fraction of the left ventricle2.5 minutesinter-group comparisons of the ejection fraction of the left ventricle in the transthoracic echocardiography after administering remimazolam- or propofol-administration for anesthesia induction

Countries

South Korea

Contacts

Primary ContactTae-Yop Kim, MD, PhD
taeyop@gmail.com+82-10-8811-6942
Backup ContactSoi Lee
soileekku@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026