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

K

Konkuk University Medical Center

Status and phase

Enrolling
Phase 4

Conditions

Surgical Procedure, Unspecified

Treatments

Drug: Propofol infusion
Drug: Remimazolam infusion

Study type

Interventional

Funder types

Other

Identifiers

NCT05412914
20210000-01

Details and patient eligibility

About

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.

Full 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

Enrollment

40 estimated patients

Sex

All

Ages

20+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • atrial fibrillation
  • unfavorable airway
  • hypotension requiring inotropic support

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

40 participants in 2 patient groups

Remimazolam
Experimental group
Description:
remimazolam infusion
Treatment:
Drug: Remimazolam infusion
Propofol
Active Comparator group
Description:
propofol infusion
Treatment:
Drug: Propofol infusion

Trial contacts and locations

1

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Central trial contact

Tae-Yop Kim, MD, PhD; Soi Lee

Data sourced from clinicaltrials.gov

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