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Completed

NCT Number: NCT01826149

Propofol Effects on Mitral Valve Annular Velocity

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

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Key information

Conditions

Valvular Heart Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Heart Valve Diseases Myocardial Ischemia Vascular Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Konkuk University Medical Center

Seoul, 143-729, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol 1.0mcg

Drug

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

Other names: Fresofol (2% propofol, Fresinius Kabi)

Propofol 2.0mcg

Drug

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

Other names: Fresofol (2% propofol, Fresinius Kabi)

Propofol 3.0mcg

Drug

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

Other names: Fresofol (2% propofol, Fresinius Kabi)

Primary outcomes

  1. Change of systolic mitral valve annular velocity (S')

    Time frame: 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 outcomes

  1. Early diastolic mitral valve annular velocity (e')

    Time frame: 10 min after achieving 3 different propofol concentrations

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

    Time frame: 10 min after achieving 3 different propofol concentrations

  3. ejection fraction

    Time frame: 10 min after achieving 3 different propofol concentrations

  4. phenylephrine infusion rate

    Time frame: 10 min after achieving 3 different propofol concentrations

Sponsors and collaborators

Lead sponsor

Konkuk University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
First posted
Apr 8, 2013
Registry last updated
Apr 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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