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

Primary Purpose

Valvular Heart Disease

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
increment of desflurane
Sponsored by
Konkuk University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Valvular Heart Disease focused on measuring Desflurane, mitral annular velocity, tissue Doppler imaging

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Konkuk University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Desflurane increment

Arm Description

increment of desflurane 0.5-1.5 MAC in remifentanil anesthesia for cardiac surgery

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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,

Full Information

First Posted
August 28, 2013
Last Updated
March 4, 2015
Sponsor
Konkuk University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02003885
Brief Title
Effect of Desflurane on Cardiac Function During Cardiac Surgery: Tissue Doppler Imaging of Mitral Valve Annular Velocity
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 Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
August 2015 (Anticipated)
Study Completion Date
September 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Konkuk University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Valvular Heart Disease
Keywords
Desflurane, mitral annular velocity, tissue Doppler imaging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Desflurane increment
Arm Type
Experimental
Arm Description
increment of desflurane 0.5-1.5 MAC in remifentanil anesthesia for cardiac surgery
Intervention Type
Drug
Intervention Name(s)
increment of desflurane
Other Intervention Name(s)
Desflurane inhalation 0.5 MAC, 1.0 MAC and 1.5 MAC
Intervention Description
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
Primary Outcome Measure Information:
Title
Peak systolic mitral annular velocity (S')
Description
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)
Time Frame
after 10 min exposure to desflurane 0.5, 1.0 and 1.5 MAC
Secondary Outcome Measure Information:
Title
diastolic mital annular veocities (E' and A'), ejection fraction (EF), Bispectral index
Description
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,
Time Frame
after 10 min exposure to desflurane 0.5, 1.0 and1.5 MAC

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tae-Yop Kim, MD, PhD
Phone
82-10-8811-6942
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tae-Yop Kim, MD, PhD
Organizational Affiliation
Konkuk University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Konkuk University Medical Center
City
Seoul
ZIP/Postal Code
143729
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seong-Ho Lee
Phone
82-2-2030-6522
Email
20110360@kuh.ac.kr

12. IPD Sharing Statement

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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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