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

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.

Study Overview

• Status: Completed
• Conditions: Ischemic Heart Disease; Valvular Heart Disease
• Intervention / Treatment: Drug: Isoflurane 1.0 MAC; Drug: Isoflurane 1.5 MAC; Drug: Isoflurane 2.0 MAC

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 143-729
    • Konkuk University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Isoflurane 1.0 MAC; 10 min-inhalation of each concentration of isoflurane, 1.0 MAC	Drug: Isoflurane 1.0 MAC; 10 min-inhalation of each concentration of isoflurane, 1.0 MAC
Experimental: Isoflurane 1.5 MAC; 10 min-inhalation of each concentration of isoflurane, 1.5 MAC	Drug: Isoflurane 1.5 MAC; 10 min-inhalation of each concentration of isoflurane, 1.5 MAC
Experimental: Isoflurane 2.0 MAC; 10 min-inhalation of each concentration of isoflurane, 2.0 MAC	Drug: Isoflurane 2.0 MAC; 10 min-inhalation of each concentration of isoflurane, 2.0 MAC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Konkuk University Medical Center
• Investigators: Principal Investigator: Tae-Yop Kim, MD, PhD, Konkuk University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: March 22, 2013
• First Submitted That Met QC Criteria: March 26, 2013
• First Posted (Estimate): March 27, 2013

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: October 31, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Monitoring; echocardiography; Isoflurane; tissue Doppler imaging; mitral valve annular velocity
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Heart Valve Diseases; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, General; Anesthetics; Anesthetics, Inhalation; Isoflurane
• Other Study ID Numbers: KUH1160052

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO