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Propofol Effects on Mitral Valve Annular Velocity

Primary Purpose

Valvular Heart Disease, Coronary Artery Disease

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Propofol 1.0mcg

Propofol 2.0mcg

Propofol 3.0mcg

About this trial

This is an interventional treatment trial for Valvular Heart Disease

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Konkuk University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Propofol 1.0mcg

Propofol 2.0mcg

Propofol 3.0mcg

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Early diastolic mitral valve annular velocity (e')

late diastolic (atrial contractile) mitral valve annular velocity (a')

ejection fraction

phenylephrine infusion rate

Full Information

NCT ID

NCT01826149

First Posted

March 22, 2013

Last Updated

April 19, 2016

Sponsor

Konkuk University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01826149

Brief Title

Propofol Effects on Mitral Valve Annular Velocity

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Completed

Study Start Date

April 2013 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Konkuk University Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Valvular Heart Disease, Coronary Artery Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

Outcomes Assessor

Allocation

Non-Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Propofol 1.0mcg

Arm Type

Experimental

Arm Description

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.

Arm Title

Propofol 2.0mcg

Arm Type

Experimental

Arm Description

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.

Arm Title

Propofol 3.0mcg

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Propofol 1.0mcg

Other Intervention Name(s)

Fresofol (2% propofol, Fresinius Kabi)

Intervention Description

Propofol dosage titration to achieve effect site concnetration at 1.0 mcg/ml using target controlled infusion.

Intervention Type

Drug

Intervention Name(s)

Propofol 2.0mcg

Other Intervention Name(s)

Fresofol (2% propofol, Fresinius Kabi)

Intervention Description

Propofol dosage titration to achieve effect site concnetration at 2.0 mcg/ml using target controlled infusion.

Intervention Type

Drug

Intervention Name(s)

Propofol 3.0mcg

Other Intervention Name(s)

Fresofol (2% propofol, Fresinius Kabi)

Intervention Description

Propofol dosage titration to achieve effect site concnetration at 3.0 mcg/ml using target controlled infusion

Primary Outcome Measure Information:

Title

Change of systolic mitral valve annular velocity (S')

Description

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.

Time Frame