Valvular Heart DiseasePhase 4NCT01826149
Propofol Effects on Mitral Valve Annular Velocity
A Phase 4 study testing Propofol 1.0mcg, Propofol 2.0mcg and Propofol 3.0mcg in people with Valvular Heart Disease and Coronary Artery Disease, run by Konkuk University Medical Center at 1 site in South Korea.
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 Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Valvular Heart Disease, Coronary Artery Disease
- What is being tested?
- Propofol 1.0mcg, Propofol 2.0mcg and Propofol 3.0mcg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2013to Dec 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing cardiac surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Propofol on Tissue Doppler Imaging of Mitral Valve Annular Velocity During Remifentanil-based Cardiac Anesthesia
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
Read the 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.
- Conditions
- Valvular Heart Disease, Coronary Artery Disease
- Being tested
- Propofol 1.0mcg, Propofol 2.0mcg, Propofol 3.0mcg
- Medical subject headings
- Heart Valve Diseases, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol 1.0mcgDrug
Also called Fresofol (2% propofol, Fresinius Kabi)
Propofol dosage titration to achieve effect site concnetration at 1.0 mcg/ml using target controlled infusion.
Propofol 2.0mcgDrug
Also called Fresofol (2% propofol, Fresinius Kabi)
Propofol dosage titration to achieve effect site concnetration at 2.0 mcg/ml using target controlled infusion.
Propofol 3.0mcgDrug
Also called Fresofol (2% propofol, Fresinius Kabi)
Propofol dosage titration to achieve effect site concnetration at 3.0 mcg/ml using target controlled infusion
| Study group | Role | What they receive |
|---|---|---|
| Propofol 1.0mcg | Experimental | 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. Receives: Drug: Propofol 1.0mcg |
| Propofol 2.0mcg | Experimental | 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. Receives: Drug: Propofol 2.0mcg |
| Propofol 3.0mcg | Experimental | 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. Receives: Drug: Propofol 3.0mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 min after achieving 3 different propofol concentrations
Secondary outcomes (4)
Early diastolic mitral valve annular velocity (e')
Measured: 10 min after achieving 3 different propofol concentrations
late diastolic (atrial contractile) mitral valve annular velocity (a')
Measured: 10 min after achieving 3 different propofol concentrations
ejection fraction
Measured: 10 min after achieving 3 different propofol concentrations
phenylephrine infusion rate
Measured: 10 min after achieving 3 different propofol concentrations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Valvular Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konkuk University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tae-Yop Kim, MD PhD, Konkuk University Medical Center
- Investigators
- Tae-yop Kim, MD, PhD, Principal investigator, Konkuk University Medical Center, Seoul, Korea, Republic of
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01826149
- Sponsor's protocol ID
- KUH1160053
- Status last verified
- Apr 2016
- First submitted
- 22 Mar 2013
- Last updated
- 20 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Bang JY, Kim S, Choi BM, Kim TY. Pharmacodynamic Analysis of the Influence of Propofol on Left Ventricular Long-Axis Systolic Performance in Cardiac Surgical Patients. J Korean Med Sci. 2019 Apr 29;34(16):e132. doi: 10.3346/jkms.2019.34.e132.
PubMed 31020819
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Propofol on Tissue Doppler Imaging of Mitral Valve Annular Velocity During Remifentanil-based Cardiac Anesthesia
- ClinicalTrials.gov ID
- NCT01826149
- Acronym / sponsor ID
- KUH1160053
- Conditions
- Valvular Heart Disease, Coronary Artery Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Dec 2015 (actual)
- First posted
- 8 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Propofol 1.0mcg | Experimental | Drug: Propofol 1.0mcgPropofol 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 2.0mcg | Experimental | Drug: Propofol 2.0mcgPropofol 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 3.0mcg | Experimental | Drug: Propofol 3.0mcgPropofol dosage titration, comparison of the effect of different concentration of propofol to the myocardial performances, namely at 3.0mcg/ml using target controlled infusion. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing cardiac surgery
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propofol 1.0mcgAlso: Fresofol (2% propofol, Fresinius Kabi)Propofol dosage titration to achieve effect site concnetration at 1.0 mcg/ml using target controlled infusion. | Drug | Propofol 1.0mcg |
| Propofol 2.0mcgAlso: Fresofol (2% propofol, Fresinius Kabi)Propofol dosage titration to achieve effect site concnetration at 2.0 mcg/ml using target controlled infusion. | Drug | Propofol 2.0mcg |
| Propofol 3.0mcgAlso: Fresofol (2% propofol, Fresinius Kabi)Propofol dosage titration to achieve effect site concnetration at 3.0 mcg/ml using target controlled infusion | Drug | Propofol 3.0mcg |
Primary outcome
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.
4 secondary outcomes
Early diastolic mitral valve annular velocity (e')
Time frame: 10 min after achieving 3 different propofol concentrations
late diastolic (atrial contractile) mitral valve annular velocity (a')
Time frame: 10 min after achieving 3 different propofol concentrations
ejection fraction
Time frame: 10 min after achieving 3 different propofol concentrations
phenylephrine infusion rate
Time frame: 10 min after achieving 3 different propofol concentrations
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2016.
- Derived from this study: PubMed 31020819Bang JY, Kim S, Choi BM, Kim TY. Pharmacodynamic Analysis of the Influence of Propofol on Left Ventricular Long-Axis Systolic Performance in Cardiac Surgical Patients. J Korean Med Sci. 2019 Apr 29;34(16):e132. doi: 10.3346/jkms.2019.34.e132.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tae-yop Kim, MD, PhD principal investigator
Konkuk University Medical Center, Seoul, Korea, Republic of
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propofol 1.0mcg, Propofol 2.0mcg and Propofol 3.0mcg in people with Valvular Heart Disease and Coronary Artery Disease, run by Konkuk University Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of systolic mitral valve annular velocity (S') (time frame: 10 min after achieving 3 different propofol concentrations). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01826149, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2016.