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

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ClinicalTrials.gov Identifier: NCT02003885
Recruitment Status : Unknown
Verified March 2015 by Tae-Yop Kim, MD PhD, Konkuk University Medical Center.
Recruitment status was:  Recruiting
First Posted : December 6, 2013
Last Update Posted : March 6, 2015
Sponsor:
Information provided by (Responsible Party):
Tae-Yop Kim, MD PhD, Konkuk University Medical Center

Brief 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 echocardiography (TEE) in cardiac surgery patients

Condition or disease Intervention/treatment Phase
Valvular Heart Disease Drug: increment of desflurane Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Effect of Desflurane on Left Ventricular Function in Remifentanil-based Anesthesia for Cardiac Surgery: Tissue Doppler Imaging of Mitral Valve Annular Velocity
Study Start Date : January 2014
Estimated Primary Completion Date : August 2015
Estimated Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Desflurane

Arm Intervention/treatment
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 Name: Desflurane inhalation 0.5 MAC, 1.0 MAC and 1.5 MAC




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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,



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02003885


Contacts
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Contact: Tae-Yop Kim, MD, PhD 82-10-8811-6942

Locations
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Korea, Republic of
Konkuk University Medical Center Recruiting
Seoul, Korea, Republic of, 143729
Contact: Seong-Ho Lee    82-2-2030-6522    20110360@kuh.ac.kr   
Sponsors and Collaborators
Konkuk University Medical Center
Investigators
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Principal Investigator: Tae-Yop Kim, MD, PhD Konkuk University Medical Center
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Responsible Party: Tae-Yop Kim, MD PhD, Professor of Anesthesiology, Konkuk University Medical Center
ClinicalTrials.gov Identifier: NCT02003885    
Other Study ID Numbers: KUH1160063
First Posted: December 6, 2013    Key Record Dates
Last Update Posted: March 6, 2015
Last Verified: March 2015
Keywords provided by Tae-Yop Kim, MD PhD, Konkuk University Medical Center:
Desflurane, mitral annular velocity, tissue Doppler imaging
Additional relevant MeSH terms:
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Heart Diseases
Heart Valve Diseases
Cardiovascular Diseases
Desflurane
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs