A Phase 4 interventional study of Remimazolam infusion and Propofol infusion in Surgical Procedure, Unspecified, sponsored by Konkuk University Medical Center. Recruiting at 1 site in Korea, Republic of. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-10.
Sponsored by Konkuk University Medical Center · Phase 4, Interventional, and Diagnostic
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.
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
Konkuk University Medical Center is the lead sponsor of 93 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
remimazolam infusion
Drug: Remimazolam infusion
propofol infusion
Drug: Propofol infusion
Remimazolam infusion for anesthesia induction
Also known as: Byfavo
Propofol infusion for anesthesia induction
Also known as: Fresofol
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
Time frame: 2.5 minutes
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 2.5 minutes
Plan to share: No
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Konkuk University Medical Center