Propofol Effects on Mitral Valve Annular Velocity

NCT ID: NCT01826149

Last Updated: 2016-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Valvular Heart Disease Coronary Artery Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Propofol 1.0mcg

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Propofol 2.0mcg

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Propofol 3.0mcg

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Propofol 1.0mcg

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

Intervention Type DRUG

Propofol 2.0mcg

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

Intervention Type DRUG

Propofol 3.0mcg

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Fresofol (2% propofol, Fresinius Kabi) Fresofol (2% propofol, Fresinius Kabi) Fresofol (2% propofol, Fresinius Kabi)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Konkuk University Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Tae-Yop Kim, MD PhD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Tae-yop Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Konkuk University Medical Center, Seoul, Korea, Republic of

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Konkuk University Medical Center

Seoul, Seoul, South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 31020819 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KUH1160053

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Vitamin C in Atrial Fibrillation Ablation
NCT03148236 COMPLETED PHASE2