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临床试验/NCT03569085
NCT03569085已完成1 期

Effect of Inhalational Anesthetics on Myocardial Deformation Indices - A Dose-Response Cross-over Study

Kathirvel Subramaniam1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2018年6月27日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
26
试验地点
1
主要终点
Global longitudinal strain of myocardium, unitless (Comparison between two inhalational anesthetics, isoflurane and sevoflurane)

研究概览

简要总结

Speckle tracking imaging measuring software will be used for offline analysis of transesophageal echocardiogram (TEE) -acquired images of the left ventricle(LV) in four chambers(4C), two chambers (2C) and long axis (LAX) views to calculate global longitudinal strain (GLS) of LV for comparisons between sevoflurane and isoflurane at the same minimum alveolar concentration ( MAC) levels.

详细描述

The primary research activity will be: baseline transthoracic echocardiogram (TTE) views taken upon the patient entering the operating room by one of the cardiothoracic anesthesiology fellows or attendings, TEE views taken by the echocardiography fellow or attending in the mid-esophageal 4C, 2C and LAX views once the patient has reached sevoflurane end-tidal minimum alveolar concentration (MAC) of 0.5, 1.0, and 1.5. Following this, sevoflurane will be changed to isoflurane and wait till complete washout of sevoflurane (i.e. end-tidal sevoflurane concentration reaches zero). Isoflurane concentration will be adjusted according to bispectral index and hemodynamics to maintain anesthesia during this period. Once complete sevoflurane wash-out has been achieved, isoflurane concentration will be adjusted and repeat images taken at the 0.5, 1.0, and 1.5 MAC values.

Investigators will establish stability at each MAC level (0.5, 1.0 and 1.5) for 5 minutes before obtaining TEE images. The whole study is done during pre- cardiopulmonary bypass(CPB) period while surgeon spending time dissecting internal mammary artery or other parts of surgical dissection before heparinization. The entire study duration will be a maximum of 35-40 minutes and this will not prolong the operating time. The adjustment of the anesthetic will be performed by the cardiac anesthesiology fellow or senior resident involved in this research along with the faculty officially performing the case. All images will be acquired prior to the initiation of cardiopulmonary bypass by the echocardiography rotating resident or research resident, cardiac anesthesiology fellow or cardiac anesthesiology attending anesthesiologist (all received extensive training in TEE to obtain those required images). Following the completion of the case and the uploading of images to a central echocardiography server, one of the study personnel will perform analysis of the images in the anesthesiology offices on a computer with post-processing software to determine strain.

MAC up to 1.5 is very well tolerated in cardiac surgical patients and is routinely used to achieve hemodynamic conditions during surgery. Use of vasopressor and inotrope to allow maintain depth of anesthesia with inhalation anesthesia agents is also routine in cardiac surgical patients and not in any way different from routine clinical care.

Hemodynamic information (heart rate, blood pressure, central venous pressure, cardiac index or pulmonary artery pressure) will be obtained after stabilization with each MAC and will be recorded immediately or extracted from the electronic medical records.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

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

入选标准

  • Adult Patients (> 18 years of age) undergoing cardiovascular surgery at University of Pittsburgh Medical Center (UPMC) Presbyterian hospital.

排除标准

  • Inability to comprehend and understand the study, Pregnancy Malignant hyperthermia Acute cardiogenic shock and ongoing chest pain Permanent pacemaker with pacemaker dependency Abnormal cardiac rhythms ( e.g. atrial fibrillation) Contraindications to TEE examination such as recent esophageal surgery, esophageal cancer/stricture The use of anesthesia maintenance with intravenous anesthesia drugs such as propofol infusions

研究组 & 干预措施

Sevoflurane then isoflurane

Experimental

干预措施: Sevoflurane (Drug)

Sevoflurane then isoflurane

Experimental

干预措施: Isoflurane (Drug)

结局指标

主要结局

Global longitudinal strain of myocardium, unitless (Comparison between two inhalational anesthetics, isoflurane and sevoflurane)

时间窗: Intraoperative period during cardiac surgery before initiation of cardiopulmonary bypass

Global longitudinal Strain measures changes in longitudinal length of myocardium and is a unitless measure. TEE images will be taken during surgery, stored on central echocardiography server, then analyzed offline using a special software to calculate global longitudinal strain (GLS). GLS of LV will then be compared between isoflurane and sevoflurane at the same MAC concentrations.

次要结局

  • Global longitudinal strain of myocardium, unitless (Dose dependent effect of sevoflurane)(Intraoperative period during cardiac surgery before initiation of cardiopulmonary bypass)
  • Global longitudinal strain of myocardium, unitless (Dose dependent effect of isoflurane)(Intraoperative period during cardiac surgery before initiation of cardiopulmonary bypass)

研究者

发起方
Kathirvel Subramaniam
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Kathirvel Subramaniam

Associate Professor

University of Pittsburgh

研究点 (1)

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