Propofol Effects on Mitral Valve Annular Velocity

Phase 4

Completed

• Conditions: Valvular Heart Disease; Coronary Artery Disease
• Interventions: Drug: Propofol 1.0mcg; Drug: Propofol 3.0mcg; Drug: Propofol 2.0mcg

• Registration Number: NCT01826149
• Lead Sponsor: Konkuk University Medical Center

Brief 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

Detailed 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.

Study Timeline

• Study First Submitted: 2013-03-22
• Study Start: 2013-04
• Study First Submitted QC: 2013-04-03
• Study First Posted: 2013-04-08
• Primary Completion: 2015-12
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-19
• Last Update Posted: 2016-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Propofol 1.0mcg	Propofol 1.0mcg	Propofol dosage titration, comparison of the effect of different concentration of propofol to the myocardial performances, namely at 1.0mcg/ml using target controlled infusion.
Propofol 3.0mcg	Propofol 3.0mcg	Propofol dosage titration, comparison of the effect of different concentration of propofol to the myocardial performances, namely at 3.0mcg/ml using target controlled infusion.
Propofol 2.0mcg	Propofol 2.0mcg	Propofol dosage titration, comparison of the effect of different concentration of propofol to the myocardial performances, namely at 2.0mcg/ml using target controlled infusion.

Primary Outcome Measures

Name	Time	Method
Change of systolic mitral valve annular velocity (S')	10 min after achieving 3 different propofol concentrations	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.

Secondary Outcome Measures

Name	Time	Method
Early diastolic mitral valve annular velocity (e')	10 min after achieving 3 different propofol concentrations
late diastolic (atrial contractile) mitral valve annular velocity (a')	10 min after achieving 3 different propofol concentrations
ejection fraction	10 min after achieving 3 different propofol concentrations
phenylephrine infusion rate	10 min after achieving 3 different propofol concentrations

Trial Locations

Locations (1)

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