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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Surgical Procedure, Unspecified

Intervention / Treatment
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* Drug: Remimazolam infusion
* Drug: Propofol infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: left ventricular ejection fraction> 50% no left ventricular regional wall motion abnormality Exclusion Criteria: atrial fibrillation unfavorable airway hypotension requiring inotropic support

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remimazolam<br>remimazolam infusion | Drug: Remimazolam infusion<br>* Remimazolam infusion for anesthesia induction<br>* Other names: Byfavo;|
| Active Comparator: Propofol<br>propofol infusion | Drug: Propofol infusion<br>* Propofol infusion for anesthesia induction<br>* Other names: Fresofol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the averaged longitudinal strain of the left ventricle (%) | inter-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 | 2.5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the longitudinal strain of the left ventricle in apical long-axis view (%) | inter-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 | 2.5 minutes | 
| the longitudinal strain of the left ventricle in apical 2 chamber view (%) | inter-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 | 2.5 minutes | 
| the longitudinal strain of the left ventricle in apical 4 chamber view (%) | inter-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 | 2.5 minutes | 
| the election fraction of the left ventricle | inter-group comparisons of the ejection fraction of the left ventricle in the transthoracic echocardiography after administering remimazolam- or propofol-administration for anesthesia induction | 2.5 minutes |