Clinical trial NCT01819012: Effect of Isoflurane on Tissue Doppler Imaging of Mitral Annulus During Cardiac Surgery
Official title: Effect of Isoflurane on Tissue Doppler Imaging of Mitral Annulus During Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Valvular Heart Disease
Ischemic Heart Disease
Keywords: Isoflurane
mitral valve annular velocity
tissue Doppler imaging
Monitoring
echocardiography
Lead sponsor: Konkuk University Medical Center
Sponsor class: OTHER
First posted: 2013-03-27
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Peak mitral annular velocity during systole(S')
timeFrame: after 10 min exposure to isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC
Secondary outcomes:
measure: ejection fraction(EF)
timeFrame: after 10 min exposure to isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC
measure: bispectral index(BIS)
timeFrame: after 10 min exposure to isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC
measure: peak velocity of mitral inflow during early relaxation(E)
timeFrame: after 10 min exposure to isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC
measure: peak velocity of mitral inflow during atrial contraction(A)
timeFrame: after 10 min exposure to isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC
measure: Peak mitral annular velocity during early diastole(E')
timeFrame: after 10 min exposure to isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC
measure: Peak mitral annular velocity during atrial contraction(A')
timeFrame: after 10 min exposure to isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
Study officials:
affiliation: Konkuk University
name: Tae-Yop Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.