- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02003885
Effect of Desflurane on Cardiac Function During Cardiac Surgery: Tissue Doppler Imaging of Mitral Valve Annular Velocity
Effect of Desflurane on Left Ventricular Function in Remifentanil-based Anesthesia for Cardiac Surgery: Tissue Doppler Imaging of Mitral Valve Annular Velocity
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tae-Yop Kim, MD, PhD
- Phone Number: 82-10-8811-6942
Study Locations
-
-
-
Seoul, Korea, Republic of, 143729
- Recruiting
- Konkuk University Medical Center
-
Contact:
- Seong-Ho Lee
- Phone Number: 82-2-2030-6522
- Email: 20110360@kuh.ac.kr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
Intervention / Treatment |
---|---|
Experimental: Desflurane increment
increment of desflurane 0.5-1.5 MAC in remifentanil anesthesia for cardiac surgery
|
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:
|
What is the study measuring?
Primary Outcome Measures
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
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
Sponsor
Investigators
- Principal Investigator: Tae-Yop Kim, MD, PhD, Konkuk University Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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