Valvular Heart DiseaseEarly Phase 1NCT01511991
Sevoflurane's Effect on Mitral Valve Annular Velocity in Cardiac Surgery
A Early Phase 1 study testing Sevoflurane dosage titration 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 sevoflurane'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 sevoflurane concentrations would be analyzed by using intraoperative transesophageal… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Valvular Heart Disease
- What is being tested?
- Sevoflurane dosage titration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2009to May 2014
- Phase
- Early Phase 1
- 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% 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 the mediastinum
- upper gastrointestinal bleeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sevoflurane's Effect on Tissue Doppler Profiles of Lateral Mitral Annulus During Cardiac Surgery
The purpose of this study is to determine sevoflurane'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 sevoflurane concentrations would be analyzed by using intraoperative transesophageal echocardiography (TEE)in cardiac surgery patients.
Read the detailed description
Following data would be determined after 10 min-exposure to each dosage of sevoflurane with 1.0, 2.0 and 3.0 inspired vol% (T1, T2 and T3, respectively) during remifentanil-based anesthesia (1.0 mcg/kg/min) for cardiac surgery (n=14):
- TDI of lateral mitral annulus at systole (S'), early filling (E') and atrial contraction (A')
- transmitral flow Doppler at early filling (E), atrial contraction (A), deceleration time;
- LV-ejection fraction (EF)
- bispectral index (BIS)
- phenylephrine-infusion rate
- other pressure derived hemodynamic parameters:heart rate; systolic, diastolic, and mean blood pressures; systolic, diastolic, and mean pulmonary artery pressures; central venous pressure (CVP), pulmonary capillary wedge pressure (PCWP), mixed venous O2 saturation (SvO2), cardiac index (CI) and stroke volume index (SVI)
- Conditions
- Valvular Heart Disease
- Being tested
- Sevoflurane dosage titration
- Keywords
- cardiac surgery, sevoflurane, tissue Doppler
- 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.
Sevoflurane dosage titrationDrug
Also called sevorane
comparisons of the effect of the 10 min-inhalation of each concentration of sevoflurane, 1.0 inspired vol%, 2.0 inspired vol% and 3.0 inspired vol% (T1, T2 and T3)
| Study group | Role | What they receive |
|---|---|---|
| sevoflurane | Experimental | 10 min exposure to sevoflurane 1.0, 2.0 and 3.0 inspiratory vol% at sevoflurane dosage titration Receives: Drug: Sevoflurane dosage titration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak mitral annular velocity during systole (S')
By using pulsed Doppler with the sample volume positioned at the lateral MV ring in the midesophageal 4-chamber view, S' would be determined just after the 10 min-exposure to each concentration of sevoflurane, 1.0 inspired vol%, 2.0 inspired vol% and 3.0 inspired vol% (T1, T2 and T3, respectively)
Measured: after 10 min exposure to sevoflurane 1.0 vol%, 2.0 vol% and 3.0 vol%
Peak mitral annular velocity during early filling (E')
By using pulsed Doppler with the sample volume positioned at the lateral MV ring in the midesophageal 4-chamber view, E' would be determined just after the 10 min-exposure to each concentration of sevoflurane, 1.0 inspired vol%, 2.0 inspired vol% and 3.0 inspired vol% (T1, T2 and T3, respectively)
Measured: after 10 min exposure to sevoflurane of 1.0 vol%, 2.0 vol% and 3.0 vol%
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, A' would be determined just after the 10 min-exposure to each concentration of sevoflurane, 1.0 inspired vol%, 2.0 inspired vol% and 3.0 inspired vol% (T1, T2 and T3, respectively)
Measured: after 10 min exposure to sevoflurane 1.0 vol%, 2.0 vol% and 3.0 vol%
Secondary outcomes (4)
ejection fraction (EF)
By using modified Simpson technique in the midesophageal 4-chamber view, EF would be determined just after the 10 min-exposure to each concentration of sevoflurane, 1.0 inspired vol%, 2.0 inspired vol% and 3.0 inspired vol% (T1, T2 and T3, respectively)
Measured: after 10 min exposure to sevoflrane 1.0vol%, 2.0 vol% and 3.0 vol%
bispectral index (BIS)
BIS would be determined just after the 10 min-exposure to each concentration of sevoflurane, 1.0 inspired vol%, 2.0 inspired vol% and 3.0 inspired vol% (T1, T2 and T3, respectively)
Measured: after 10 min exposure to sevoflurane 1.0 vol%, 2.0 vol% and 3.0 vol%
peak velocity of mitral inflow during early relaxation (E)
By using pulsed Doppler with the sample volume positioned at the lMV opening in the midesophageal 4-chamber view, S' would be determined just after the 10 min-exposure to each concentration of sevoflurane, 1.0 inspired vol%, 2.0 inspired vol% and 3.0 inspired vol% (T1, T2 and T3, respectively)
Measured: after 10 min exposure to sevoflurane 1.0 vol%, 2.0 vol% and 3.0 vol%
peak velocity of mitral inflow during atrial contraction (A)
By using pulsed Doppler with the sample volume positioned at the tip of MV oeneing in the midesophageal 4-chamber view, "A" would be determined just after the 10 min-exposure to each concentration of sevoflurane, 1.0 inspired vol%, 2.0 inspired vol% and 3.0 inspired vol% (T1, T2 and T3, respectively)
Measured: after 10 min exposure to sevoflurane 1.0 vol%, 2.0 vol% and 3.0 vol%
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2012 (estimated)
- Study startMay 2009
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01511991
- Sponsor's protocol ID
- KUH1160037
- Status last verified
- Feb 2015
- First submitted
- 11 Jan 2012
- Last updated
- 24 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bruch C, Gradaus R, Gunia S, Breithardt G, Wichter T. Doppler tissue analysis of mitral annular velocities: evidence for systolic abnormalities in patients with diastolic heart failure. J Am Soc Echocardiogr. 2003 Oct;16(10):1031-6. doi: 10.1016/S0894-7317(03)00634-5.
PubMed 14566295Waggoner AD, Bierig SM. Tissue Doppler imaging: a useful echocardiographic method for the cardiac sonographer to assess systolic and diastolic ventricular function. J Am Soc Echocardiogr. 2001 Dec;14(12):1143-52. doi: 10.1067/mje.2001.115391.
PubMed 11734780
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sevoflurane's Effect on Tissue Doppler Profiles of Lateral Mitral Annulus During Cardiac Surgery
- ClinicalTrials.gov ID
- NCT01511991
- Acronym / sponsor ID
- KUH1160037
- Conditions
- Valvular Heart Disease
- Keywords
- cardiac surgery, sevoflurane, tissue Doppler
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 19 Jan 2012 (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 sevoflurane'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 sevoflurane concentrations would be analyzed by using intraoperative transesophageal echocardiography (TEE)in cardiac surgery patients.
Detailed description
Following data would be determined after 10 min-exposure to each dosage of sevoflurane with 1.0, 2.0 and 3.0 inspired vol% (T1, T2 and T3, respectively) during remifentanil-based anesthesia (1.0 mcg/kg/min) for cardiac surgery (n=14):
- TDI of lateral mitral annulus at systole (S'), early filling (E') and atrial contraction (A')
- transmitral flow Doppler at early filling (E), atrial contraction (A), deceleration time;
- LV-ejection fraction (EF)
- bispectral index (BIS)
- phenylephrine-infusion rate
- other pressure derived hemodynamic parameters:heart rate; systolic, diastolic, and mean blood pressures; systolic, diastolic, and mean pulmonary artery pressures; central venous pressure (CVP), pulmonary capillary wedge pressure (PCWP), mixed venous O2 saturation (SvO2), cardiac index (CI) and stroke volume index (SVI)
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sevoflurane | Experimental | Drug: Sevoflurane dosage titration10 min exposure to sevoflurane 1.0, 2.0 and 3.0 inspiratory vol% at sevoflurane dosage titration |
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 (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 |
|---|---|---|
| Sevoflurane dosage titrationAlso: sevoranecomparisons of the effect of the 10 min-inhalation of each concentration of sevoflurane, 1.0 inspired vol%, 2.0 inspired vol% and 3.0 inspired vol% (T1, T2 and T3) | Drug | sevoflurane |
Primary outcome
Peak mitral annular velocity during systole (S')
Time frame: after 10 min exposure to sevoflurane 1.0 vol%, 2.0 vol% and 3.0 vol%
By using pulsed Doppler with the sample volume positioned at the lateral MV ring in the midesophageal 4-chamber view, S' would be determined just after the 10 min-exposure to each concentration of sevoflurane, 1.0 inspired vol%, 2.0 inspired vol% and 3.0 inspired vol% (T1, T2 and T3, respectively)
Peak mitral annular velocity during early filling (E')
Time frame: after 10 min exposure to sevoflurane of 1.0 vol%, 2.0 vol% and 3.0 vol%
By using pulsed Doppler with the sample volume positioned at the lateral MV ring in the midesophageal 4-chamber view, E' would be determined just after the 10 min-exposure to each concentration of sevoflurane, 1.0 inspired vol%, 2.0 inspired vol% and 3.0 inspired vol% (T1, T2 and T3, respectively)
peak mitral annular velocity during atrial contraction(A')
Time frame: after 10 min exposure to sevoflurane 1.0 vol%, 2.0 vol% and 3.0 vol%
By using pulsed Doppler with the sample volume positioned at the lateral MV ring in the midesophageal 4-chamber view, A' would be determined just after the 10 min-exposure to each concentration of sevoflurane, 1.0 inspired vol%, 2.0 inspired vol% and 3.0 inspired vol% (T1, T2 and T3, respectively)
4 secondary outcomes
ejection fraction (EF)
Time frame: after 10 min exposure to sevoflrane 1.0vol%, 2.0 vol% and 3.0 vol%
bispectral index (BIS)
Time frame: after 10 min exposure to sevoflurane 1.0 vol%, 2.0 vol% and 3.0 vol%
peak velocity of mitral inflow during early relaxation (E)
Time frame: after 10 min exposure to sevoflurane 1.0 vol%, 2.0 vol% and 3.0 vol%
peak velocity of mitral inflow during atrial contraction (A)
Time frame: after 10 min exposure to sevoflurane 1.0 vol%, 2.0 vol% and 3.0 vol%
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 24 Feb 2015.
- Background: PubMed 14566295Bruch C, Gradaus R, Gunia S, Breithardt G, Wichter T. Doppler tissue analysis of mitral annular velocities: evidence for systolic abnormalities in patients with diastolic heart failure. J Am Soc Echocardiogr. 2003 Oct;16(10):1031-6. doi: 10.1016/S0894-7317(03)00634-5.
- Background: PubMed 11734780Waggoner AD, Bierig SM. Tissue Doppler imaging: a useful echocardiographic method for the cardiac sonographer to assess systolic and diastolic ventricular function. J Am Soc Echocardiogr. 2001 Dec;14(12):1143-52. doi: 10.1067/mje.2001.115391.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Sevoflurane dosage titration 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: finished, as of the sponsor's last update on 24 Feb 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Peak mitral annular velocity during systole (S') (time frame: after 10 min exposure to sevoflurane 1.0 vol%, 2.0 vol% and 3.0 vol%). The study lists 3 primary outcomes in all. 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 NCT01511991, which also lists 2 linked publications.
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 24 Feb 2015.