Back to resultsThoracic Epidural Reduces Risks of Increased Left Ventricular Mass Index During Coronary Artery Bypass Graft Surgery
Primary Purpose
Ischemia Coronary Artery Origin
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
thoracic epidural
Sponsored by
About this trial
This is an interventional supportive care trial for Ischemia Coronary Artery Origin focused on measuring Epidural., ventricular mass, Aortic valve, coronary bypass
Eligibility Criteria
Inclusion Criteria:
- patients between 65 and 75 years with:
- physical status of ASA II and IV
- who underwent aortic valve replacement (for isolated or mixed aortic valve lesions) alone or in addition to-coronary artery bypass grafting. in the Cardio-thoracic Surgery Department of Tanta University Hospital during a two year period were enrolled in this study.
- Before inclusion in the study, all patients were evaluated with extended echocardiographic imaging, full history including cardiac symptoms (dyspnea, orthopnea, paroxysmal nocturnal dyspnea, chest pain, and low cardiac output symptoms) was taken from all patients. General (including body weight and height) and systematic (including cardiac examination) examinations were done to all patients.
Exclusion Criteria:
- Patients with an ejection fraction of 0.3, myocardial infarction within the last 4 weeks
- diabetes
- severe pulmonary or arterial hypertension.
- a contraindication for HTEA.
- patients without preoperative optimal echocardiographic imaging were excluded.
- Among the exclusion criteria were the administration of ticlopidine within 15 days before surgery and the administration of platelet glycoprotein IIb/IIIa inhibitors. In common with previous investigators, we did not consider treatment with low-molecular-weight heparin and aspirin below the dosage of 160 mg/day to be contraindications to the procedure.
- Patients with significant aortic insufficiency were also excluded from the study in order to avoid introducing further variables that could influence hemodynamic response to the procedure.
- Patients were excluded if they underwent an AVR on an emergency basis, had poor acoustic windows for adequate echocardiographic assessment, and/or did not undergo an echocardiogram before the operation.
Sites / Locations
- Ahmed Said Elgebaly
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
No Intervention
No Intervention
No Intervention
No Intervention
Arm Label
HTEA Group + N(LVMI)+ AVR alone(n=10)
HTEA Group + ↑ (LVMI)+ AVR alone(n=10)
HTEA Group + N(LVMI)+ AVR + CABG(n=10)
HTEA Group +↑ (LVMI)+ AVR + CABG(n=10)
Control(GA) Group+ N(LVMI)+ AVR alone(n=10)
Control(GA) Group+ ↑ (LVMI)+ AVR alone(n=10)
Control(GA) Group+ N(LVMI)+ AVR + CABG(n=10)
Control(GA) Group+↑ (LVMI)+ AVR + CABG(n=10)
Arm Description
HTEA Group + N(LVMI)+ AVR alone(n=10)
HTEA Group + ↑ (LVMI)+ AVR alone(n=10)
HTEA Group + N(LVMI)+ AVR + CABG(n=10)
HTEA Group +↑ (LVMI)+ AVR + CABG(n=10)
Control(GA) Group+ N(LVMI)+ AVR alone(n=10)
Control(GA) Group+ ↑ (LVMI)+ AVR alone(n=10)
(GA) Group+ N(LVMI)+ AVR + CABG(n=10)
Control(GA) Group+↑ (LVMI)+ AVR + CABG(n=10)
Outcomes
Primary Outcome Measures
The changes in LV systolic.
LV end systolic diameter (LVESD)
The changes in LV diastolic.
Left ventricular end diastolic diameter (LVEDD)
ejection fraction percent
changes in percentage, of how much blood the left ventricle pumps out with each contraction.
FAC percent
Fractional Area Change (FAC) percent
Fractional Area Change (FAC)
EDA
end-diastolic area (EDA)
Secondary Outcome Measures
Perioperative changes in heart rate (HR).
during evaluation of hemodynamic changes.
changes in mean arterial blood pressure (MAP)
during evaluation of hemodynamic changes.
the changes incidence of ischemic ECG.
Holter monitor tapes were analyzed for myocardial ischemia based the criteria of horizontal or down-sloping ST-segment depression of > 1 mm below the baseline, lasting for at least 1 min. Events were separated by at least 5 min without ECG ischemia ECG changes included new ST-T changes, T inversion, Q waves and/or a bundle branch block
Full Information
NCT ID
NCT03719248
First Posted
October 15, 2018
Last Updated
October 22, 2018
Sponsor
Ahmed Said Elgebaly,MD
Collaborators
Tanta University
1. Study Identification
Unique Protocol Identification Number
NCT03719248
Brief Title
Thoracic Epidural Reduces Risks of Increased Left Ventricular Mass Index During Coronary Artery Bypass Graft Surgery
Official Title
High Thoracic Epidural Reduces Risks of Increased Left Ventricular Mass Index and Coronary Vascular Disease During Aortic Valve Replacement Alone or in Addition to Coronary Artery Bypass Graft Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
January 1, 2018 (Actual)
Study Completion Date
January 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ahmed Said Elgebaly,MD
Collaborators
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Increased left ventricular mass index (LVMI) results from aortic valve lesions as an adaptive mechanism to help limit systolic wall stress and preserve ejection fraction (EF). This study Aim to investigate the effects of sympathetic blockade by HTEA on systolic and diastolic LV function in patients undergoing aortic valve replacement (AVR) alone or in addition to coronary artery bypass graft (CABG). It Designs as A prospective randomized controlled comparative study in which eighty patients received either general anesthesia ( control group n=40) or with high thoracic epidural analgesia(HTEA group n=40). Each group subdivided to normal (LVM) (n=20)or increased(LVM) group(n=20), all submitted to (AVR) alone or in addition to (CABG).
Detailed Description
Background: Increased left ventricular mass index (LVMI) results from aortic valve lesions as an adaptive mechanism to help limit systolic wall stress and preserve ejection fraction (EF).
Aim: to investigate the effects of sympathetic blockade by HTEA on systolic and diastolic LV function in patients undergoing aortic valve replacement (AVR) alone or in addition to coronary artery bypass graft (CABG).
Design: A prospective randomized controlled comparative study. Methods: Eighty patients received either general anesthesia ( control group n=40) or with high thoracic epidural analgesia(HTEA group n=40). Each group subdivided to normal (LVM) (n=20)or increased(LVM) group(n=20), all submitted to (AVR) alone or in addition to (CABG).Perioperative heart rate (HR), mean arterial blood pressure (MAP), incidence of ischemic ECG, LV systolic and diastolic function changes were measured till 48 h, postoperatively.
Patients were subjected to ambulatory Holter monitoring, Hemodynamic measures, intraoperative transesophageal echocardiography (iTEE) and postoperative Trans Thoracic Echocardiography (TTE) to assess myocardial ischemia and Left ventricular systolic/diastolic function.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemia Coronary Artery Origin
Keywords
Epidural., ventricular mass, Aortic valve, coronary bypass
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HTEA Group + N(LVMI)+ AVR alone(n=10)
Arm Type
Active Comparator
Arm Description
HTEA Group + N(LVMI)+ AVR alone(n=10)
Arm Title
HTEA Group + ↑ (LVMI)+ AVR alone(n=10)
Arm Type
Active Comparator
Arm Description
HTEA Group + ↑ (LVMI)+ AVR alone(n=10)
Arm Title
HTEA Group + N(LVMI)+ AVR + CABG(n=10)
Arm Type
Active Comparator
Arm Description
HTEA Group + N(LVMI)+ AVR + CABG(n=10)
Arm Title
HTEA Group +↑ (LVMI)+ AVR + CABG(n=10)
Arm Type
Active Comparator
Arm Description
HTEA Group +↑ (LVMI)+ AVR + CABG(n=10)
Arm Title
Control(GA) Group+ N(LVMI)+ AVR alone(n=10)
Arm Type
No Intervention
Arm Description
Control(GA) Group+ N(LVMI)+ AVR alone(n=10)
Arm Title
Control(GA) Group+ ↑ (LVMI)+ AVR alone(n=10)
Arm Type
No Intervention
Arm Description
Control(GA) Group+ ↑ (LVMI)+ AVR alone(n=10)
Arm Title
Control(GA) Group+ N(LVMI)+ AVR + CABG(n=10)
Arm Type
No Intervention
Arm Description
(GA) Group+ N(LVMI)+ AVR + CABG(n=10)
Arm Title
Control(GA) Group+↑ (LVMI)+ AVR + CABG(n=10)
Arm Type
No Intervention
Arm Description
Control(GA) Group+↑ (LVMI)+ AVR + CABG(n=10)
Intervention Type
Device
Intervention Name(s)
thoracic epidural
Other Intervention Name(s)
high thoracic epidural anesthesia (HTEA) combined with GA, transesophageal and transthoracic echocardiography, Holter ECG
Intervention Description
high thoracic epidural anesthesia (HTEA) combined with GA, transesophageal, transthoracic echocardiography and Holter ECG
Primary Outcome Measure Information:
Title
The changes in LV systolic.
Description
LV end systolic diameter (LVESD)
Time Frame
5 minutes pre-operatively, 5 minutes after induction of anesthesia,15 minutes before,15 minutes after bypass and at 6, 12, 24 and 48 hour, postoperatively.
Title
The changes in LV diastolic.
Description
Left ventricular end diastolic diameter (LVEDD)
Time Frame
5 minutes pre-operatively, 5 minutes after induction of anesthesia,15 minutes before,15 minutes after bypass and at 6, 12, 24 and 48 hour, postoperatively.
Title
ejection fraction percent
Description
changes in percentage, of how much blood the left ventricle pumps out with each contraction.
Time Frame
5 minutes pre-operatively, 5 minutes after induction of anesthesia,15 minutes before,15 minutes after bypass and at 6, 12, 24 and 48 hour, postoperatively.
Title
FAC percent
Description
Fractional Area Change (FAC) percent
Fractional Area Change (FAC)
Time Frame
5 minutes pre-operatively, 5 minutes after induction of anesthesia,15 minutes before,15 minutes after bypass and at 6, 12, 24 and 48 hour, postoperatively.
Title
EDA
Description
end-diastolic area (EDA)
Time Frame
5 minutes pre-operatively, 5 minutes after induction of anesthesia,15 minutes before,15 minutes after bypass and at 6, 12, 24 and 48 hour, postoperatively.
Secondary Outcome Measure Information:
Title
Perioperative changes in heart rate (HR).
Description
during evaluation of hemodynamic changes.
Time Frame
5 minutes pre-operatively, 5 minutes after induction of anesthesia,15 minutes before,15 minutes after bypass and at 6, 12, 24 and 48 hour, postoperatively
Title
changes in mean arterial blood pressure (MAP)
Description
during evaluation of hemodynamic changes.
Time Frame
5 minutes pre-operatively, 5 minutes after induction of anesthesia,15 minutes before,15 minutes after bypass and at 6, 12, 24 and 48 hour, postoperatively
Title
the changes incidence of ischemic ECG.
Description
Holter monitor tapes were analyzed for myocardial ischemia based the criteria of horizontal or down-sloping ST-segment depression of > 1 mm below the baseline, lasting for at least 1 min. Events were separated by at least 5 min without ECG ischemia ECG changes included new ST-T changes, T inversion, Q waves and/or a bundle branch block
Time Frame
5 minutes pre-operatively, 5 minutes after induction of anesthesia,15 minutes before,15 minutes after bypass and at 6, 12, 24 and 48 hour, postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
patients between 65 and 75 years with:
physical status of ASA II and IV
who underwent aortic valve replacement (for isolated or mixed aortic valve lesions) alone or in addition to-coronary artery bypass grafting. in the Cardio-thoracic Surgery Department of Tanta University Hospital during a two year period were enrolled in this study.
Before inclusion in the study, all patients were evaluated with extended echocardiographic imaging, full history including cardiac symptoms (dyspnea, orthopnea, paroxysmal nocturnal dyspnea, chest pain, and low cardiac output symptoms) was taken from all patients. General (including body weight and height) and systematic (including cardiac examination) examinations were done to all patients.
Exclusion Criteria:
Patients with an ejection fraction of 0.3, myocardial infarction within the last 4 weeks
diabetes
severe pulmonary or arterial hypertension.
a contraindication for HTEA.
patients without preoperative optimal echocardiographic imaging were excluded.
Among the exclusion criteria were the administration of ticlopidine within 15 days before surgery and the administration of platelet glycoprotein IIb/IIIa inhibitors. In common with previous investigators, we did not consider treatment with low-molecular-weight heparin and aspirin below the dosage of 160 mg/day to be contraindications to the procedure.
Patients with significant aortic insufficiency were also excluded from the study in order to avoid introducing further variables that could influence hemodynamic response to the procedure.
Patients were excluded if they underwent an AVR on an emergency basis, had poor acoustic windows for adequate echocardiographic assessment, and/or did not undergo an echocardiogram before the operation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ahmed S Elgebaly, MD
Organizational Affiliation
assist .professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ahmed Said Elgebaly
City
Tanta
Country
Egypt
12. IPD Sharing Statement
Citations:
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15920175
Citation
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Citation
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Citation
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Thoracic Epidural Reduces Risks of Increased Left Ventricular Mass Index During Coronary Artery Bypass Graft Surgery
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