Ischemia Coronary Artery Origin Clinical Trial
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
| NCT number | NCT03719248 |
| Other study ID # | TantaU |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | January 1, 2017 |
| Est. completion date | January 1, 2018 |
| Verified date | October 2018 |
| Source | Tanta University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 80 |
| Est. completion date | January 1, 2018 |
| Est. primary completion date | January 1, 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 65 Years to 75 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Egypt | Ahmed Said Elgebaly | Tanta |
| Lead Sponsor | Collaborator |
|---|---|
| Ahmed Said Elgebaly,MD | Tanta University |
Egypt,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The changes in LV systolic. | LV end systolic diameter (LVESD) | 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. | |
| Primary | The changes in LV diastolic. | Left ventricular end diastolic diameter (LVEDD) | 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. | |
| Primary | ejection fraction percent | changes in percentage, of how much blood the left ventricle pumps out with each contraction. | 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. | |
| Primary | FAC percent | Fractional Area Change (FAC) percent Fractional Area Change (FAC) |
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. | |
| Primary | EDA | end-diastolic area (EDA) | 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 | Perioperative changes in heart rate (HR). | during evaluation of hemodynamic changes. | 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 | changes in mean arterial blood pressure (MAP) | during evaluation of hemodynamic changes. | 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 | 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 | 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 |