Effect of Desflurane on Cardiac Function During Cardiac Surgery: Tissue Doppler Imaging of Mitral Valve Annular Velocity

March 4, 2015 updated by: Tae-Yop Kim, MD PhD, Konkuk University Medical Center

Effect of Desflurane on Left Ventricular Function in Remifentanil-based Anesthesia for Cardiac Surgery: Tissue Doppler Imaging of Mitral Valve Annular Velocity

The purpose of this study is to determine desflurane's dose-dependent effect on left ventricular (LV) function in cardiac surgery. The change of tissue Doppler imaging (TDI) of lateral mitral valve annular velocity at three different desflurane concentrations would be analyzed by using intraoperative transesophageal echocardiography (TEE) in cardiac surgery patients

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Tissue Doppler imaging (TDI ) of mitral annular velocity during the cardiac cycle has been introduced as a reliable method for analysis of systolic and diastolic LV ling-axix function , efficacy of diastolic TDI profile, including early early relaxation (E') and atrial contraction (A') and has been suggested to be useful in predicting the postoperative clinical outcomes and the impact of isoflurane on LV diastolic function.

Desflurane is widely used in cardiac surgery patients due to its beneficial effects , but many studies have shown that desflurane reduces myocardial contractility in a dose-dependent manner, and compromises left ventricular( LV) function We hypothesized that desflurane , even at a clinical dosage, would affects intraoperative LV systolic function in a dose-dependent manner and thus produce significant changes int the TDI profiles of mitral annular velocity.

So we planned to study the changes in TDI profiles of lateral mitral annular velocity at the clinical desflurane dosage during remifentanil based anesthesia for cardiac surgery

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Tae-Yop Kim, MD, PhD
  • Phone Number: 82-10-8811-6942

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Ages eligible for study : 20 years to 65 years Genders eligible for study : Both

Inclusion Criteria:

  • Patients undergoing cardiac surgery

Exclusion Criteria:

  • Low ejection fraction <50% in preoperative transthoracic echocardiography
  • Atrial fibrillation
  • Pacemaker
  • Pericardial and infiltrative myocardial disease
  • Mitral annular calcification, surgical rings, prosthetic mitral valves
  • Lateral left ventricular regional wall motion abnormality
  • Esophageal spasm, stricture, laceration, perforation, and diverticulum
  • Diaphragmatic hernia
  • History of extensive radiation to mediastinum
  • Upper gastrointestinal bleeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Desflurane increment
increment of desflurane 0.5-1.5 MAC in remifentanil anesthesia for cardiac surgery
Drug: increment of desflurane

After achieving stable hemodynamics and BIS 40-60 with desflurnae 0.5 MAC and remifentanil 0.7-1.0 mcg/kg/min (T1), data including S', E', A', EF, E, A and BIS are determined.

After 10 min exposure to the increased desflurane dosage 1.0 MAC (T2), data are determiend. After 10 min exposure to the increased desflurane dosage 1.5 MAC (T3), data are determined.

Reduction of BP is managed by the increment of phenylephrine infusion

Other Names:
  • Desflurane inhalation 0.5 MAC, 1.0 MAC and 1.5 MAC

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Peak systolic mitral annular velocity (S')
Time Frame: after 10 min exposure to desflurane 0.5, 1.0 and 1.5 MAC
Peak systolic mitral annular velocity (S') using tissue Doppler imaging By using pulsed Doppler with the sample volume positioned at the lateral mitral valve (MV)ring in the midesophageal 4-chamber view, S' would be determined just after the 10 min-exposure to each concentration of desflurane, 0.5 MAC, 1.0 MAC and 1.5 MAC (T1, T2 and T3, respectively)
after 10 min exposure to desflurane 0.5, 1.0 and 1.5 MAC

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
diastolic mital annular veocities (E' and A'), ejection fraction (EF), Bispectral index
Time Frame: after 10 min exposure to desflurane 0.5, 1.0 and1.5 MAC
Peak mitral annular velocity during early diastole (E'): By using pulsed Doppler with the sample volume positioned at the lateral MV ring in the midesophageal 4-chamber view, Peak mitral annular velocity during atrial contraction(A'): By using pulsed Doppler with the sample volume positioned at the lateral MV ring in the midesophageal 4-chamber view, ejection fraction (EF): By using modified Simpson technique in the midesophageal 4-chamber view, bispectral index (BIS) peak velocity of mitral inflow during early relaxation (E): By using pulsed Doppler with the sample volume positioned at the IMV opening in the midesophageal 4-chamber view, peak velocity of mitral inflow during atrial contraction (A): By using pulsed Doppler with the sample volume positioned at the tip of MV opening in the midesophageal 4-chamber view,
after 10 min exposure to desflurane 0.5, 1.0 and1.5 MAC

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Konkuk University Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tae-Yop Kim, MD, PhD, Konkuk University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2015

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 28, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 6, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 6, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KUH1160063

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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