Influence of Anesthesia on Mechanical Efficiency of Left Ventricle in Patients Undergoing Open Heart Surgery
NCT ID: NCT01397331
Last Updated: 2018-04-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE4
28 participants
INTERVENTIONAL
2010-07-01
2012-06-27
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Difference in Postoperative Cognitive Dysfunction and Myocardial Ischemia Between Propofol and Isoflurane
NCT00908518
The Effects of the Anesthetic Drug Propofol on the Way the Heart Recovers Between Beats
NCT00358618
Propofol Induction's Effect on Cardiac Function
NCT02408341
Effect of Propofol on Renal Injury in Patients Undergoing Valvular Heart Surgery
NCT01384643
Anesthesia and Lymphocytes Apoptosis
NCT01461551
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
From mechanical point of view the goal of the cardiovascular system is to distribute the kinetic energy of blood ejection from the left ventricle (LV) to body organs with minimal loss and greatest efficiency. The left ventricle and the arterial circulation work as "coupled" system. The ideal coupling supposes that a maximum of the energy produced by the LV is converted into forward flow to perfuse the body organs. This matching between "the source" (LV) and "the load" (arterial circulation) is governed by the mechanical properties of these parts of cardiovascular system.
Variety of pathological conditions change this coupling in such a way that may adversely affect the organ blood flow in the presence of unchanged or even high cardiac output, or significantly increase the metabolic demand on the LV for the maintenance of adequate systemic perfusion due to decrease of mechanical efficiency of the work produced by LV.
Although effects of anesthetic agents on myocardial contractility and peripheral vascular tone were extensively studied in clinical conditions, little is known about their influence on ventriculo-arterial coupling. Propofol and inhalational agents appear to impair this equilibrium in animal experiments. This is not surprising, since these agents cause complex dose-dependent changes in many physiologic parameters, including myocardial contractility, left ventricular preload and afterload, diastolic properties of myocardium and baroreceptor control of hemodynamics. Although these properties of anesthetic agents have been delineated extensively, very limited data characterizing their influence on ventriculo-arterial coupling in clinical conditions exist. This information is especially meaningful while planning the anesthetic management of patients undergoing cardiac surgery, where maintenance of circulatory homeostasis is of outmost importance. Since the main hemodynamic goal during anesthesia of the patient with cardiovascular disease is to provide optimal tissue perfusion with minimal myocardial oxygen demand, i.e. with maximal mechanical efficiency, knowledge of anesthetic induced changes in ventriculo-arterial coupling is extremely relevant from the clinical point of view.
The most convenient method for the evaluation of ventriculo-arterial coupling is the analysis of the relationship between LV end-systolic elastance, load-independent measure of myocardial contractility, and effective arterial end-systolic elastance, measure mechanical loading conditions8. Physiological data necessary for the calculation of these parameters may be acquired in relatively non-invasive way by combining and analyzing together recording of arterial blood pressure waveform and data of changes of LV volume, which may be obtained by means of echocardiography.
Objectives
General
The aim of the study is to delineate and compare the changes in ventriculo-arterial coupling caused by two popular anesthetic protocols commonly used in cardiac surgery (intravenous, based on the infusion of propofol, versus inhalational, based on isoflurane) on different stages of the surgery.
Specific
1. To compare influence of two anesthetic protocols on myocardial contractility at the end of the surgery.
2. To assess net changes in effective arterial elastance produced by surgery with the use of cardiopulmonary bypass and evaluate possible differences between these two anesthetic protocols in respect to changes of arterial tone.
3. To evaluate the preservation of ventriculo-arterial coupling by two different anesthetic modes.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Inhalational anesthesia
Group of patients undergoing the surgery under anesthesia based on inhalational anesthetic
Isoflurane
Anesthesia based on inhalation of 1-1.5 Minimal Alveolar Concentration of Isoflurane with the addition of infusion of remifentanil
TIVA
Group of patients undergoing the surgery under total intravenous anesthesia
Propofol
Anesthesia based on the infusion of 2-5 mg/kg/h of propofol with the addition of infusion of remifentanil
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Isoflurane
Anesthesia based on inhalation of 1-1.5 Minimal Alveolar Concentration of Isoflurane with the addition of infusion of remifentanil
Propofol
Anesthesia based on the infusion of 2-5 mg/kg/h of propofol with the addition of infusion of remifentanil
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* History of previous cardiac surgery.
* Significant arrhythmias.
* More than trivial valvular disorder.
* Absence of written informed consent.
* Contraindications for transesophageal echocardiography.
* Pregnant women.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sheba Medical Center
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Department of Anesthesia and Intensive Care, Sheba Medical Center, Tel Hashomer, Israel 52621
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sergey Preisman, M.D.
Role: PRINCIPAL_INVESTIGATOR
Department of Anesthesia and Intensive Care, Sheba Medical Center, Israel 52621
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Anesthesia and Intensive Care, Sheba Medical Center
Tel Hashomer, Ramat Gan, , Israel
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SHEBA-09-7199-SP-CTIL
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.