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

Not Applicable

Completed

• Conditions: Valvular Heart Disease; Ischemic Heart Disease
• Interventions: Drug: Isoflurane 2.0 MAC; Drug: Isoflurane 1.5 MAC; Drug: Isoflurane 1.0 MAC

• Registration Number: NCT01819012
• Lead Sponsor: Konkuk University Medical Center

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.

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-22
• Study First Submitted QC: 2013-03-26
• Study First Posted: 2013-03-27
• Primary Completion: 2013-11
• Study Completion: 2014-03
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-31
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• patients undergoing cardiac surgery

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Isoflurane 2.0 MAC	Isoflurane 2.0 MAC	10 min-inhalation of each concentration of isoflurane, 2.0 MAC
Isoflurane 1.5 MAC	Isoflurane 1.5 MAC	10 min-inhalation of each concentration of isoflurane, 1.5 MAC
Isoflurane 1.0 MAC	Isoflurane 1.0 MAC	10 min-inhalation of each concentration of isoflurane, 1.0 MAC

Primary Outcome Measures

Name	Time	Method
Peak mitral annular velocity during systole(S')	after 10 min exposure to isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC	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)

Secondary Outcome Measures

Name	Time	Method
ejection fraction(EF)	after 10 min exposure to isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC	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
peak velocity of mitral inflow during atrial contraction(A)	after 10 min exposure to isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC	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)
peak velocity of mitral inflow during early relaxation(E)	after 10 min exposure to isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC	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)
Peak mitral annular velocity during early diastole(E')	after 10 min exposure to isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC	By using pulsed Doppler with the sample volume positioned at the lateral MV ring
Peak mitral annular velocity during atrial contraction(A')	after 10 min exposure to isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC	By using pulsed Doppler with the sample volume positioned at the lateral MV ring
bispectral index(BIS)	after 10 min exposure to isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC	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

Trial Locations

Locations (1)

Konkuk University Medical Center; 🇰🇷 Seoul, Korea, Republic of