Ignite Creation Date:
2024-05-06 @ 12:14 PM
Last Modification Date:
2024-10-26 @ 12:56 PM
Study NCT ID:
NCT03719248
Status:
COMPLETED
Last Update Posted:
2018-10-25
First Post:
2018-10-15
Brief Title:
Thoracic Epidural Reduces Risks of Increased Left Ventricular Mass Index During Coronary Artery Bypass Graft Surgery
Sponsor:
Ahmed Said ElgebalyMD
Organization:
Tanta University
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 n40 or with high thoracic epidural analgesiaHTEA group n40 Each group subdivided to normal LVM n20or increasedLVM groupn20 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 n40 or with high thoracic epidural analgesiaHTEA group n40 Each group subdivided to normal LVM n20or increasedLVM groupn20 all submitted to AVR alone or in addition to CABGPerioperative 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 systolicdiastolic function
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 n40 or with high thoracic epidural analgesiaHTEA group n40 Each group subdivided to normal LVM n20or increasedLVM groupn20 all submitted to AVR alone or in addition to CABGPerioperative 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 systolicdiastolic function
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None