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Propofol Effects on Mitral Valve Annular Velocity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01826149
Recruitment Status : Completed
First Posted : April 8, 2013
Last Update Posted : April 20, 2016
Sponsor:
Information provided by (Responsible Party):
Tae-Yop Kim, MD PhD, 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

Condition or disease Intervention/treatment Phase
Valvular Heart Disease Coronary Artery Disease Drug: Propofol 1.0mcg Drug: Propofol 2.0mcg Drug: Propofol 3.0mcg Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Propofol on Tissue Doppler Imaging of Mitral Valve Annular Velocity During Remifentanil-based Cardiac Anesthesia
Study Start Date : April 2013
Actual Primary Completion Date : December 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol

Arm Intervention/treatment
Experimental: 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.
Drug: Propofol 1.0mcg
Propofol dosage titration to achieve effect site concnetration at 1.0 mcg/ml using target controlled infusion.
Other Name: Fresofol (2% propofol, Fresinius Kabi)

Experimental: 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.
Drug: Propofol 2.0mcg
Propofol dosage titration to achieve effect site concnetration at 2.0 mcg/ml using target controlled infusion.
Other Name: Fresofol (2% propofol, Fresinius Kabi)

Experimental: 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.
Drug: Propofol 3.0mcg
Propofol dosage titration to achieve effect site concnetration at 3.0 mcg/ml using target controlled infusion
Other Name: Fresofol (2% propofol, Fresinius Kabi)




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01826149


Locations
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Korea, Republic of
Konkuk University Medical Center
Seoul, Korea, Republic of, 143-729
Sponsors and Collaborators
Konkuk University Medical Center
Investigators
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Principal Investigator: Tae-yop Kim, MD, PhD Konkuk University Medical Center, Seoul, Korea, Republic of

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tae-Yop Kim, MD PhD, Professor, Konkuk University Medical Center
ClinicalTrials.gov Identifier: NCT01826149    
Other Study ID Numbers: KUH1160053
First Posted: April 8, 2013    Key Record Dates
Last Update Posted: April 20, 2016
Last Verified: April 2016
Additional relevant MeSH terms:
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Coronary Artery Disease
Heart Diseases
Heart Valve Diseases
Coronary Disease
Myocardial Ischemia
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics