Effect of Isoflurane on Tissue Doppler Imaging of Mitral Annulus During Cardiac Surgery

NCT ID: NCT01819012

Last Updated: 2016-11-02

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

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-03-31

Brief Summary

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The purpose of this study is to determine Isoflurane's dose-dependent effect on left ventricular (LV) systolic function in cardiac surgery. The change of tissue Doppler imaging (TDI) of lateral mitral valve annular systolic velocity at three different isoflurane concentrations would be analyzed by using intraoperative transesophageal echocardiography (TEE) in cardiac surgery patients.

Detailed Description

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Isoflurane is widely used in cardiac surgery patients due to its beneficial effects, but many studies have shown that isoflurane reduces myocardial contractility in a dose-dependent manner, and compromises left ventricular (LV) function.

Tissue Doppler imaging (TDI) of mitral annular velocity during the cardiac cycle has been introduced as a reliable method for analysis of systolic and diastolic LV long-axis function. Efficacy of systolic and diastolic TDI profiles, including systole (S'), early early relaxation (E')and atrial contraction (A') have been suggested to be useful in predicting the impact of isoflurane on LV systolic and diastolic function.

The investigators hypothesized that isoflurane, even at a clinical dosage, would affects intraoperative LV systolic function in a dose-dependent manner and thus produce significant changes int the TDI profiles of systolic mitral annular velocity (S').

So the investigators planned to study the changes in S' of lateral mitral annulus at the clinical isoflurane dosage during remifentanil based anesthesia for cardiac surgery.

Conditions

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Valvular Heart Disease Ischemic Heart Disease

Keywords

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Isoflurane mitral valve annular velocity tissue Doppler imaging Monitoring echocardiography

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Isoflurane 1.0 MAC

10 min-inhalation of each concentration of isoflurane, 1.0 MAC

Group Type EXPERIMENTAL

Isoflurane 1.0 MAC

Intervention Type DRUG

10 min-inhalation of each concentration of isoflurane, 1.0 MAC

Isoflurane 1.5 MAC

10 min-inhalation of each concentration of isoflurane, 1.5 MAC

Group Type EXPERIMENTAL

Isoflurane 1.5 MAC

Intervention Type DRUG

10 min-inhalation of each concentration of isoflurane, 1.5 MAC

Isoflurane 2.0 MAC

10 min-inhalation of each concentration of isoflurane, 2.0 MAC

Group Type EXPERIMENTAL

Isoflurane 2.0 MAC

Intervention Type DRUG

10 min-inhalation of each concentration of isoflurane, 2.0 MAC

Interventions

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Isoflurane 1.0 MAC

10 min-inhalation of each concentration of isoflurane, 1.0 MAC

Intervention Type DRUG

Isoflurane 1.5 MAC

10 min-inhalation of each concentration of isoflurane, 1.5 MAC

Intervention Type DRUG

Isoflurane 2.0 MAC

10 min-inhalation of each concentration of isoflurane, 2.0 MAC

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patients undergoing cardiac surgery

Exclusion Criteria

* low ejection fraction \< 50% in preoperative transthoracic echocardiography
* atrial fibrillation
* pacemaker
* pericardial and infiltrative myocardial disease
* mitral annular calcification, surgical rings, prosthetic mitral valves
* lateral left ventricular regional wall motion abnormality
* esophageal spasm, stricture, laceration, perforation, and diverticulum diaphragmatic hernia
* history of extensive radiation to mediastinum
* upper gastrointestinal bleeding
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Konkuk University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Tae-Yop Kim, MD PhD

Professor of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tae-Yop Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Konkuk University

Locations

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Konkuk University Medical Center

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

References

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Kim JD, Son I, Kwon WK, Sung TY, Sidik H, Kim K, Kang H, Bang J, Yeo GE, Lee DK, Kim TY. Isoflurane's Effect on Intraoperative Systolic Left Ventricular Performance in Cardiac Valve Surgery Patients. J Korean Med Sci. 2018 Jan 22;33(4):e28. doi: 10.3346/jkms.2018.33.e28.

Reference Type DERIVED
PMID: 29318795 (View on PubMed)

Other Identifiers

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KUH1160052

Identifier Type: -

Identifier Source: org_study_id