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

NCT ID: NCT05412914

Last Updated: 2023-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-26

Study Completion Date

2024-01-01

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

Conditions

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Surgical Procedure, Unspecified

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Remimazolam

remimazolam infusion

Group Type EXPERIMENTAL

Remimazolam infusion

Intervention Type DRUG

Remimazolam infusion for anesthesia induction

Propofol

propofol infusion

Group Type ACTIVE_COMPARATOR

Propofol infusion

Intervention Type DRUG

Propofol infusion for anesthesia induction

Interventions

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Remimazolam infusion

Remimazolam infusion for anesthesia induction

Intervention Type DRUG

Propofol infusion

Propofol infusion for anesthesia induction

Intervention Type DRUG

Other Intervention Names

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Byfavo Fresofol

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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Konkuk University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Tae-Yop Kim, MD PhD

Professor, Department of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tae-Yop Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Konkuk University Medical Center

Locations

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Konkuk University Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Tae-Yop Kim, MD, PhD

Role: CONTACT

+82-10-8811-6942

Soi Lee

Role: CONTACT

Facility Contacts

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Seong-Ho Lee

Role: primary

+82-2-2030-6542

Other Identifiers

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20210000-01

Identifier Type: -

Identifier Source: org_study_id

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