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临床试验/NCT05412914
NCT05412914招募中4 期

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

Konkuk University Medical Center1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年1月26日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
招募中
入组人数
40
试验地点
1
主要终点
the averaged longitudinal strain of the left ventricle (%)

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • atrial fibrillation
  • unfavorable airway
  • hypotension requiring inotropic support

研究组 & 干预措施

Remimazolam

Experimental

remimazolam infusion

干预措施: Remimazolam infusion (Drug)

Propofol

Active Comparator

propofol infusion

干预措施: Propofol infusion (Drug)

结局指标

主要结局

the averaged longitudinal strain of the left ventricle (%)

时间窗: 2.5 minutes

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

次要结局

  • the longitudinal strain of the left ventricle in apical 2 chamber view (%)(2.5 minutes)
  • the longitudinal strain of the left ventricle in apical 4 chamber view (%)(2.5 minutes)
  • the election fraction of the left ventricle(2.5 minutes)
  • the longitudinal strain of the left ventricle in apical long-axis view (%)(2.5 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tae-Yop Kim, MD PhD

Professor, Department of Anesthesiology

Konkuk University Medical Center

研究点 (1)

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