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NCT01826149 Clinical Trial

Propofol Effects on Mitral Valve Annular Velocity

Coronary Artery Disease Clinical Trial

Official title:
The Effect of Propofol on Tissue Doppler Imaging of Mitral Valve Annular Velocity During Remifentanil-based Cardiac Anesthesia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01826149
Other study ID # KUH1160053
Secondary ID
Status Completed
Phase Phase 4
First received March 22, 2013
Last updated April 19, 2016
Start date April 2013

Study information
Verified date April 2016
Source Konkuk University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is primarily to determine the effects of propofol at different concentration on the mitral valve annulus by using Tissue Doppler Imaging

Description:

The purpose of this study is to evaluate the effects of different concentration of propofol on patients who are undergoing cardiac surgery. The patients will receive infusion remifentanil 0.5mcg/kg/min with different target-site propofol concentration namely 1.0ng/ml, 2.0ng/ml and 3.0ng/ml. Tissue Doppler Imaging by transesophageal echocardiography will be done to assess the changes in cardiac function.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender All
Age group 20 Years to 65 Years
Eligibility Inclusion Criteria:

patients undergoing cardiac surgery

Exclusion Criteria:

low ejection fraction < 50% on transthoracic echocardiography atrial fibrillation pacemaker pericardial and infiltrative myocardial disease mitral annular calcification, surgical rings, prosthetic mitral valve lateral left ventricular wall motion abnormality oesophageal abnormality history of extensive radiation to the mediastinum upper gastrointestinal bleeding

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Propofol 1.0mcg
Propofol dosage titration to achieve effect site concnetration at 1.0 mcg/ml using target controlled infusion.
• Propofol 2.0mcg
Propofol dosage titration to achieve effect site concnetration at 2.0 mcg/ml using target controlled infusion.
• Propofol 3.0mcg
Propofol dosage titration to achieve effect site concnetration at 3.0 mcg/ml using target controlled infusion

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 Change of systolic mitral valve annular velocity (S') To examine the effect of Propofol at different effect-site concentration ( 1.0 ng/ml, 2.0 ng/ml and 3.0 ng/ml) on S' (systolic mitral valve annular velocity) during remifentanil-based anesthesia. 10 min after achieving 3 different propofol concentrations
Secondary Early diastolic mitral valve annular velocity (e') 10 min after achieving 3 different propofol concentrations
Secondary late diastolic (atrial contractile) mitral valve annular velocity (a') 10 min after achieving 3 different propofol concentrations
Secondary ejection fraction 10 min after achieving 3 different propofol concentrations
Secondary phenylephrine infusion rate 10 min after achieving 3 different propofol concentrations
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