Effect of Isoflurane on Tissue Doppler Imaging of Mitral Annulus During Cardiac Surgery
Primary Purpose
Valvular Heart Disease, Ischemic Heart Disease
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Isoflurane 1.0 MAC
Isoflurane 1.5 MAC
Isoflurane 2.0 MAC
Sponsored by
About this trial
This is an interventional treatment trial for Valvular Heart Disease focused on measuring Isoflurane, mitral valve annular velocity, tissue Doppler imaging, Monitoring, echocardiography
Eligibility Criteria
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 Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Isoflurane 1.0 MAC
Isoflurane 1.5 MAC
Isoflurane 2.0 MAC
Arm Description
10 min-inhalation of each concentration of isoflurane, 1.0 MAC
10 min-inhalation of each concentration of isoflurane, 1.5 MAC
10 min-inhalation of each concentration of isoflurane, 2.0 MAC
Outcomes
Primary Outcome Measures
Peak mitral annular velocity during systole(S')
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 isoflurane, 1.0 MAC, 1.5 MAC and 2.0 MAC (T1, T2 and T3, respectively)
Secondary Outcome Measures
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 isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC
bispectral index(BIS)
BIS would be determined just after the 10 min-exposure to each concentration of isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC
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, E' would be determined just after the 10 min-exposure to each concentration of isoflurane, 1.0 MAC, 1.5 MAC and 2.0 MAC(T1, T2 and T3, respectively)
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, "A" would be determined just after the 10 min-exposure to each concentration of isoflurane, 1.0 MAC, 1.5 MAC and 2.0 MAC(T1, T2 and T3, respectively)
Peak mitral annular velocity during early diastole(E')
By using pulsed Doppler with the sample volume positioned at the lateral MV ring
Peak mitral annular velocity during atrial contraction(A')
By using pulsed Doppler with the sample volume positioned at the lateral MV ring
Full Information
NCT ID
NCT01819012
First Posted
March 22, 2013
Last Updated
October 31, 2016
Sponsor
Konkuk University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01819012
Brief Title
Effect of Isoflurane on Tissue Doppler Imaging of Mitral Annulus During Cardiac Surgery
Official Title
Effect of Isoflurane on Tissue Doppler Imaging of Mitral Annulus During Cardiac Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
March 2014 (Actual)
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 Isoflurane's dose-dependent effect on left ventricular (LV) systolic function in cardiac surgery. The change of tissue Doppler imaging (TDI) of lateral mitral valve annular systolic velocity at three different isoflurane concentrations would be analyzed by using intraoperative transesophageal echocardiography (TEE) in cardiac surgery patients.
Detailed Description
Isoflurane is widely used in cardiac surgery patients due to its beneficial effects, but many studies have shown that isoflurane reduces myocardial contractility in a dose-dependent manner, and compromises left ventricular (LV) function.
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 long-axis function. Efficacy of systolic and diastolic TDI profiles, including systole (S'), early early relaxation (E')and atrial contraction (A') have been suggested to be useful in predicting the impact of isoflurane on LV systolic and diastolic function.
The investigators hypothesized that isoflurane, 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 systolic mitral annular velocity (S').
So the investigators planned to study the changes in S' of lateral mitral annulus at the clinical isoflurane 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, Ischemic Heart Disease
Keywords
Isoflurane, mitral valve annular velocity, tissue Doppler imaging, Monitoring, echocardiography
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Isoflurane 1.0 MAC
Arm Type
Experimental
Arm Description
10 min-inhalation of each concentration of isoflurane, 1.0 MAC
Arm Title
Isoflurane 1.5 MAC
Arm Type
Experimental
Arm Description
10 min-inhalation of each concentration of isoflurane, 1.5 MAC
Arm Title
Isoflurane 2.0 MAC
Arm Type
Experimental
Arm Description
10 min-inhalation of each concentration of isoflurane, 2.0 MAC
Intervention Type
Drug
Intervention Name(s)
Isoflurane 1.0 MAC
Intervention Description
10 min-inhalation of each concentration of isoflurane, 1.0 MAC
Intervention Type
Drug
Intervention Name(s)
Isoflurane 1.5 MAC
Intervention Description
10 min-inhalation of each concentration of isoflurane, 1.5 MAC
Intervention Type
Drug
Intervention Name(s)
Isoflurane 2.0 MAC
Intervention Description
10 min-inhalation of each concentration of isoflurane, 2.0 MAC
Primary Outcome Measure Information:
Title
Peak mitral annular velocity during systole(S')
Description
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 isoflurane, 1.0 MAC, 1.5 MAC and 2.0 MAC (T1, T2 and T3, respectively)
Time Frame
after 10 min exposure to isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC
Secondary Outcome Measure Information:
Title
ejection fraction(EF)
Description
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 isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC
Time Frame
after 10 min exposure to isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC
Title
bispectral index(BIS)
Description
BIS would be determined just after the 10 min-exposure to each concentration of isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC
Time Frame
after 10 min exposure to isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC
Title
peak velocity of mitral inflow during early relaxation(E)
Description
By using pulsed Doppler with the sample volume positioned at the IMV opening in the midesophageal 4-chamber view, E' would be determined just after the 10 min-exposure to each concentration of isoflurane, 1.0 MAC, 1.5 MAC and 2.0 MAC(T1, T2 and T3, respectively)
Time Frame
after 10 min exposure to isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC
Title
peak velocity of mitral inflow during atrial contraction(A)
Description
By using pulsed Doppler with the sample volume positioned at the tip of MV opening in the midesophageal 4-chamber view, "A" would be determined just after the 10 min-exposure to each concentration of isoflurane, 1.0 MAC, 1.5 MAC and 2.0 MAC(T1, T2 and T3, respectively)
Time Frame
after 10 min exposure to isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC
Title
Peak mitral annular velocity during early diastole(E')
Description
By using pulsed Doppler with the sample volume positioned at the lateral MV ring
Time Frame
after 10 min exposure to isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC
Title
Peak mitral annular velocity during atrial contraction(A')
Description
By using pulsed Doppler with the sample volume positioned at the lateral MV ring
Time Frame
after 10 min exposure to isoflurane 1.0 MAC, 1.5 MAC and 2.0 MAC
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tae-Yop Kim, MD, PhD
Organizational Affiliation
Konkuk University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Konkuk University Medical Center
City
Seoul
ZIP/Postal Code
143-729
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29318795
Citation
Kim JD, Son I, Kwon WK, Sung TY, Sidik H, Kim K, Kang H, Bang J, Yeo GE, Lee DK, Kim TY. Isoflurane's Effect on Intraoperative Systolic Left Ventricular Performance in Cardiac Valve Surgery Patients. J Korean Med Sci. 2018 Jan 22;33(4):e28. doi: 10.3346/jkms.2018.33.e28.
Results Reference
derived
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Effect of Isoflurane on Tissue Doppler Imaging of Mitral Annulus During Cardiac Surgery
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