NCT01826149

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2013

Completed
10 days until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 8, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Last Updated

April 20, 2016

Status Verified

April 1, 2016

Enrollment Period

2.7 years

First QC Date

March 22, 2013

Last Update Submit

April 19, 2016

Conditions

Valvular Heart DiseaseCoronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • 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.

    10 min after achieving 3 different propofol concentrations

Secondary Outcomes (4)

  • Early diastolic mitral valve annular velocity (e')

    10 min after achieving 3 different propofol concentrations

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

    10 min after achieving 3 different propofol concentrations

  • ejection fraction

    10 min after achieving 3 different propofol concentrations

  • phenylephrine infusion rate

    10 min after achieving 3 different propofol concentrations

Study Arms (3)

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.

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.

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.

Drug: Propofol 3.0mcg

Interventions

Propofol 1.0mcgDRUG

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

Also known as: Fresofol (2% propofol, Fresinius Kabi)
Propofol 1.0mcg
Propofol 2.0mcgDRUG

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

Also known as: Fresofol (2% propofol, Fresinius Kabi)
Propofol 2.0mcg
Propofol 3.0mcgDRUG

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

Also known as: Fresofol (2% propofol, Fresinius Kabi)
Propofol 3.0mcg

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients undergoing cardiac surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konkuk University Medical Center

Seoul, Seoul, 143-729, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 31020819DERIVED

MeSH Terms

Conditions

Heart Valve DiseasesCoronary Artery Disease

Interventions

Propofol

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesCoronary DiseaseMyocardial IschemiaArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Tae-yop Kim, MD, PhD

    Konkuk University Medical Center, Seoul, Korea, Republic of

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 22, 2013

First Posted

April 8, 2013

Study Start

April 1, 2013

Primary Completion

December 1, 2015

Last Updated

April 20, 2016

Record last verified: 2016-04

Locations

KR(1)