Clinical trial NCT05412914: Remimazolam and Propofol on the Left Ventricular Strain During Anesthesia Induction for Non-cardiac Surgery
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Surgical Procedure, Unspecified
Lead sponsor: Konkuk University Medical Center
Sponsor class: OTHER
First posted: 2022-06-09
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* atrial fibrillation
* unfavorable airway
* hypotension requiring inotropic support

Primary outcomes:
measure: the averaged longitudinal strain of the left ventricle (%)
timeFrame: 2.5 minutes
Secondary outcomes:
measure: the longitudinal strain of the left ventricle in apical long-axis view (%)
timeFrame: 2.5 minutes
measure: the longitudinal strain of the left ventricle in apical 2 chamber view (%)
timeFrame: 2.5 minutes
measure: the longitudinal strain of the left ventricle in apical 4 chamber view (%)
timeFrame: 2.5 minutes
measure: the election fraction of the left ventricle
timeFrame: 2.5 minutes
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
Study officials:
affiliation: Konkuk University Medical Center
name: Tae-Yop Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: