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

Surgical Procedure, Unspecified Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05412914
• Other study ID #: 20210000-01
• Status: Recruiting
• Phase: Phase 4
• Start date: January 26, 2023
• Est. completion date: January 1, 2024

Study information

• Verified date: October 2023
• Source: Konkuk University Medical Center
• Contact: Tae-Yop Kim, MD, PhD
• Phone: +82-10-8811-6942
• Email: taeyop[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• left ventricular ejection fraction> 50%

• no left ventricular regional wall motion abnormality

Exclusion Criteria:

• atrial fibrillation

• unfavorable airway

• hypotension requiring inotropic support

Related Conditions & MeSH terms

• Surgical Procedure, Unspecified

Intervention

Drug:
• Remimazolam infusion
Remimazolam infusion for anesthesia induction
• Propofol infusion
Propofol infusion for anesthesia induction

Locations

Country	Name	City	State
Korea, Republic of	Konkuk University Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Konkuk University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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