Influence of Anesthesia on Mechanical Efficiency of Left Ventricle in Patients Undergoing Open Heart Surgery

Heart; Dysfunction Postoperative, Cardiac Surgery Clinical Trial

Official title:

Influence of Anesthesia on Mechanical Efficiency of Left Ventricle in Patients Undergoing Open Heart Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01397331
• Other study ID #: SHEBA-09-7199-SP-CTIL
• Status: Terminated
• Phase: Phase 4
• First received: July 14, 2011
• Last updated: April 23, 2018
• Start date: July 1, 2010
• Est. completion date: June 27, 2012

Study information

• Verified date: July 2011
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: June 27, 2012
• Est. primary completion date: June 27, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Israel	Department of Anesthesia and Intensive Care, Sheba Medical Center	Tel Hashomer, Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of the relationship between left ventricular end-systolic elastance and effective arterial end-systolic elastance.		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	Changes in vascular tone and cardiac afterload	arterial end-systolic elastance, left ventricular end-systolic stress	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	Changes of measures of global systolic left ventricular function	left ventricular end-systolic elastance, systolic strain and strain rate, myocardial performance index, ejection fraction	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