Clinical trial NCT01397331: Influence of Anesthesia on Mechanical Efficiency of Left Ventricle in Patients Undergoing Open Heart Surgery
Official title: Influence of Anesthesia on Mechanical Efficiency of Left Ventricle in Patients Undergoing Open Heart Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Heart; Dysfunction Postoperative, Cardiac Surgery
Disorder; Heart, Functional, Postoperative, Cardiac Surgery
Keywords: inhalational anesthesia
intravenous anesthesia
cardiac surgery
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2011-07-19
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes of the relationship between left ventricular end-systolic elastance and effective arterial end-systolic elastance.
timeFrame: 15 minutes and 30 minutes after the induction of anesthesia in Inhalational Group and TIVA Group respectively, 15 minutes after the separation from cardiopulmonary bypass, and before the transfer of the patient to the Intensive Care Unit in both groups
Secondary outcomes:
measure: Changes in vascular tone and cardiac afterload
timeFrame: 15 minutes and 30 minutes after the induction of anesthesia in Inhalational Group and TIVA Group respectively, 15 minutes after the separation from cardiopulmonary bypass, and before the transfer of the patient to the Intensive Care Unit in both groups
measure: Changes of measures of global systolic left ventricular function
timeFrame: 15 minutes and 30 minutes after the induction of anesthesia in Inhalational Group and TIVA Group respectively, 15 minutes after the separation from cardiopulmonary bypass, and before the transfer of the patient to the Intensive Care Unit in both groups
Other outcomes:
Locations:
city: Tel Hashomer, Ramat Gan
country: Israel
facility: Department of Anesthesia and Intensive Care, Sheba Medical Center
Study officials:
affiliation: Department of Anesthesia and Intensive Care, Sheba Medical Center, Israel 52621
name: Sergey Preisman, M.D.
role: PRINCIPAL_INVESTIGATOR
References: