Valvular Heart DiseaseNCT02003885
Effect of Desflurane on Cardiac Function During Cardiac Surgery: Tissue Doppler Imaging of Mitral Valve Annular Velocity
A study testing increment of desflurane in people with Valvular Heart Disease, run by Konkuk University Medical Center at 1 site in South Korea.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Valvular Heart Disease
- What is being tested?
- increment of desflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2014to Sep 2015
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing cardiac surgery
Who cannot join
- 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
Show all 10Show fewer
- Esophageal spasm, stricture, laceration, perforation, and diverticulum
- Diaphragmatic hernia
- History of extensive radiation to mediastinum
- Upper gastrointestinal bleeding
Trial locations and contacts
1 site in 1 country.
Tae-Yop Kim, MD, PhD contact
South Korea1 site, 1 recruiting
- Recruiting
Konkuk University Medical Center
Seoul, Seoul, 143729
Seong-Ho Lee, 82-2-2030-6522, 20110360@kuh.ac.kr
About this study
Official title: 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
Read the 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
- Conditions
- Valvular Heart Disease
- Being tested
- increment of desflurane
- Keywords
- Desflurane, mitral annular velocity, tissue Doppler imaging
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
increment of desfluraneDrug
Also called Desflurane inhalation 0.5 MAC, 1.0 MAC and 1.5 MAC
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
| Study group | Role | What they receive |
|---|---|---|
| Desflurane increment | Experimental | increment of desflurane 0.5-1.5 MAC in remifentanil anesthesia for cardiac surgery Receives: Drug: increment of desflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak systolic mitral annular velocity (S')
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)
Measured: after 10 min exposure to desflurane 0.5, 1.0 and 1.5 MAC
Secondary outcomes (1)
diastolic mital annular veocities (E' and A'), ejection fraction (EF), Bispectral index
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,
Measured: after 10 min exposure to desflurane 0.5, 1.0 and1.5 MAC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionAug 2015 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02003885
- Sponsor's protocol ID
- KUH1160063
- Status last verified
- Mar 2015
- First submitted
- 28 Aug 2013
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Desflurane on Left Ventricular Function in Remifentanil-based Anesthesia for Cardiac Surgery: Tissue Doppler Imaging of Mitral Valve Annular Velocity
- ClinicalTrials.gov ID
- NCT02003885
- Acronym / sponsor ID
- KUH1160063
- Conditions
- Valvular Heart Disease
- Keywords
- Desflurane, mitral annular velocity, tissue Doppler imaging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 6 Dec 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 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
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Desflurane increment | Experimental | Drug: increment of desfluraneincrement of desflurane 0.5-1.5 MAC in remifentanil anesthesia for cardiac surgery |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing cardiac surgery
Key exclusion criteria (10 listed)
- Low ejection fraction <50% in preoperative transthoracic echocardiography
- Atrial fibrillation
- Pacemaker
- Pericardial and infiltrative myocardial disease
- Mitral annular calcification, surgical rings, prosthetic mitral valves
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 |
|---|---|---|
| increment of desfluraneAlso: Desflurane inhalation 0.5 MAC, 1.0 MAC and 1.5 MACAfter 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 | Drug | Desflurane increment |
Primary outcome
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)
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2015.
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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 contact
Tae-Yop Kim, MD, PhD principal investigator
Konkuk University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing increment of desflurane in people with Valvular Heart 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 10 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: status not confirmed, as of the sponsor's last update on 6 Mar 2015. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tae-Yop Kim, MD, PhD (82-10-8811-6942), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak systolic mitral annular velocity (S') (time frame: after 10 min exposure to desflurane 0.5, 1.0 and 1.5 MAC). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Mar 2015.