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

Ischemic Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01819012
• Other study ID #: KUH1160052
• Status: Completed
• Phase: N/A
• First received: March 22, 2013
• Last updated: October 31, 2016
• Start date: March 2013
• Est. completion date: March 2014

Study information

• Verified date: October 2016
• Source: Konkuk University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Heart Valve Diseases
• Ischemic Heart Disease
• Myocardial Ischemia
• Valvular Heart Disease

Intervention

Drug:
• Isoflurane 1.0 MAC
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
• Isoflurane 2.0 MAC
10 min-inhalation of each concentration of isoflurane, 2.0 MAC

Locations

Country	Name	City	State
Korea, Republic of	Konkuk University Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Konkuk University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak mitral annular velocity during systole(S')	By using pulsed Doppler with the sample volume positioned at the lateral mitral valve (MV)ring in the midesophageal 4-chamber view, S' would be determined just after the 10 min-exposure to each concentration of isoflurane, 1.0 MAC, 1.5 MAC and 2.0 MAC (T1, T2 and T3, respectively)	after 10 min exposure to isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC	No
Secondary	ejection fraction(EF)	By using modified Simpson technique in the midesophageal 4-chamber view, EF would be determined just after the 10 min-exposure to each concentration of isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC	after 10 min exposure to isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC	No
Secondary	bispectral index(BIS)	BIS would be determined just after the 10 min-exposure to each concentration of isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC	after 10 min exposure to isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC	No
Secondary	peak velocity of mitral inflow during early relaxation(E)	By using pulsed Doppler with the sample volume positioned at the IMV opening in the midesophageal 4-chamber view, E' would be determined just after the 10 min-exposure to each concentration of isoflurane, 1.0 MAC, 1.5 MAC and 2.0 MAC(T1, T2 and T3, respectively)	after 10 min exposure to isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC	No
Secondary	peak velocity of mitral inflow during atrial contraction(A)	By using pulsed Doppler with the sample volume positioned at the tip of MV opening in the midesophageal 4-chamber view, "A" would be determined just after the 10 min-exposure to each concentration of isoflurane, 1.0 MAC, 1.5 MAC and 2.0 MAC(T1, T2 and T3, respectively)	after 10 min exposure to isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC	No
Secondary	Peak mitral annular velocity during early diastole(E')	By using pulsed Doppler with the sample volume positioned at the lateral MV ring	after 10 min exposure to isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC	No
Secondary	Peak mitral annular velocity during atrial contraction(A')	By using pulsed Doppler with the sample volume positioned at the lateral MV ring	after 10 min exposure to isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC	No