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

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

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-01

Study Completion Date

2012-06-27

Brief Summary

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The aim of the study is to delineate and compare the changes in coupled mechanical properties of left ventricle and arterial vascular bed 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.

Detailed Description

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Background

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

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Heart; Dysfunction Postoperative, Cardiac Surgery Disorder; Heart, Functional, Postoperative, Cardiac Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Inhalational anesthesia

Group of patients undergoing the surgery under anesthesia based on inhalational anesthetic

Group Type ACTIVE_COMPARATOR

Isoflurane

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

Anesthesia based on the infusion of 2-5 mg/kg/h of propofol with the addition of infusion of remifentanil

Interventions

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Isoflurane

Anesthesia based on inhalation of 1-1.5 Minimal Alveolar Concentration of Isoflurane with the addition of infusion of remifentanil

Intervention Type DRUG

Propofol

Anesthesia based on the infusion of 2-5 mg/kg/h of propofol with the addition of infusion of remifentanil

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing elective cardiac surgery

Exclusion Criteria

* Emergent surgery.
* History of previous cardiac surgery.
* Significant arrhythmias.
* More than trivial valvular disorder.
* Absence of written informed consent.
* Contraindications for transesophageal echocardiography.
* Pregnant women.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Department of Anesthesia and Intensive Care, Sheba Medical Center, Tel Hashomer, Israel 52621

Principal Investigators

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Sergey Preisman, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesia and Intensive Care, Sheba Medical Center, Israel 52621

Locations

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Department of Anesthesia and Intensive Care, Sheba Medical Center

Tel Hashomer, Ramat Gan, , Israel

Site Status

Countries

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Israel

Other Identifiers

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SHEBA-09-7199-SP-CTIL

Identifier Type: -

Identifier Source: org_study_id

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