Thoracic Epidural Reduces Risks of Increased Left Ventricular Mass Index During Coronary Artery Bypass Graft Surgery
NCT ID: NCT03719248
Last Updated: 2018-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2017-01-01
2018-01-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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HTEA Group + N(LVMI)+ AVR alone(n=10)
HTEA Group + N(LVMI)+ AVR alone(n=10)
thoracic epidural
high thoracic epidural anesthesia (HTEA) combined with GA, transesophageal, transthoracic echocardiography and Holter ECG
HTEA Group + ↑ (LVMI)+ AVR alone(n=10)
HTEA Group + ↑ (LVMI)+ AVR alone(n=10)
thoracic epidural
high thoracic epidural anesthesia (HTEA) combined with GA, transesophageal, transthoracic echocardiography and Holter ECG
HTEA Group + N(LVMI)+ AVR + CABG(n=10)
HTEA Group + N(LVMI)+ AVR + CABG(n=10)
thoracic epidural
high thoracic epidural anesthesia (HTEA) combined with GA, transesophageal, transthoracic echocardiography and Holter ECG
HTEA Group +↑ (LVMI)+ AVR + CABG(n=10)
HTEA Group +↑ (LVMI)+ AVR + CABG(n=10)
thoracic epidural
high thoracic epidural anesthesia (HTEA) combined with GA, transesophageal, transthoracic echocardiography and Holter ECG
Control(GA) Group+ N(LVMI)+ AVR alone(n=10)
Control(GA) Group+ N(LVMI)+ AVR alone(n=10)
No interventions assigned to this group
Control(GA) Group+ ↑ (LVMI)+ AVR alone(n=10)
Control(GA) Group+ ↑ (LVMI)+ AVR alone(n=10)
No interventions assigned to this group
Control(GA) Group+ N(LVMI)+ AVR + CABG(n=10)
(GA) Group+ N(LVMI)+ AVR + CABG(n=10)
No interventions assigned to this group
Control(GA) Group+↑ (LVMI)+ AVR + CABG(n=10)
Control(GA) Group+↑ (LVMI)+ AVR + CABG(n=10)
No interventions assigned to this group
Interventions
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thoracic epidural
high thoracic epidural anesthesia (HTEA) combined with GA, transesophageal, transthoracic echocardiography and Holter ECG
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* diabetes
* severe pulmonary or arterial hypertension.
* a contraindication for HTEA.
* patients without preoperative optimal echocardiographic imaging were excluded.
* 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.
65 Years
75 Years
ALL
Yes
Sponsors
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Tanta University
OTHER
Ahmed Said Elgebaly,MD
OTHER
Responsible Party
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Ahmed Said Elgebaly,MD
director
Principal Investigators
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ahmed S Elgebaly, MD
Role: PRINCIPAL_INVESTIGATOR
assist .professor
Locations
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Ahmed Said Elgebaly
Tanta, , Egypt
Countries
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References
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Schmidt C, Hinder F, Van Aken H, Theilmeier G, Bruch C, Wirtz SP, Burkle H, Guhs T, Rothenburger M, Berendes E. The effect of high thoracic epidural anesthesia on systolic and diastolic left ventricular function in patients with coronary artery disease. Anesth Analg. 2005 Jun;100(6):1561-1569. doi: 10.1213/01.ANE.0000154963.29271.36.
Berendes E, Schmidt C, Van Aken H, Hartlage MG, Wirtz S, Reinecke H, Rothenburger M, Scheld HH, Schluter B, Brodner G, Walter M. Reversible cardiac sympathectomy by high thoracic epidural anesthesia improves regional left ventricular function in patients undergoing coronary artery bypass grafting: a randomized trial. Arch Surg. 2003 Dec;138(12):1283-90; discussion 1291. doi: 10.1001/archsurg.138.12.1283.
Blomberg S, Emanuelsson H, Kvist H, Lamm C, Ponten J, Waagstein F, Ricksten SE. Effects of thoracic epidural anesthesia on coronary arteries and arterioles in patients with coronary artery disease. Anesthesiology. 1990 Nov;73(5):840-7. doi: 10.1097/00000542-199011000-00008.
Svircevic V, Nierich AP, Moons KG, Diephuis JC, Ennema JJ, Brandon Bravo Bruinsma GJ, Kalkman CJ, van Dijk D. Thoracic epidural anesthesia for cardiac surgery: a randomized trial. Anesthesiology. 2011 Feb;114(2):262-70. doi: 10.1097/ALN.0b013e318201d2de.
Conrady AO, Rudomanov OG, Zaharov DV, Krutikov AN, Vahrameeva NV, Yakovleva OI, Alexeeva NP, Shlyakhto EV. Prevalence and determinants of left ventricular hypertrophy and remodelling patterns in hypertensive patients: the St. Petersburg study. Blood Press. 2004;13(2):101-9. doi: 10.1080/08037050410031855.
Guarracino F, Cariello C, Tritapepe L, Doroni L, Baldassarri R, Danella A, Stefani M. Transoesophageal echocardiography during coronary artery bypass procedures: impact on surgical planning. HSR Proc Intensive Care Cardiovasc Anesth. 2010;2(1):43-9.
El-Morsy GZ, El-Deeb A. The outcome of thoracic epidural anesthesia in elderly patients undergoing coronary artery bypass graft surgery. Saudi J Anaesth. 2012 Jan;6(1):16-21. doi: 10.4103/1658-354X.93048.
Crescenzi G, Landoni G, Monaco F, Bignami E, De Luca M, Frau G, Rosica C, Zangrillo A. Epidural anesthesia in elderly patients undergoing coronary artery bypass graft surgery. J Cardiothorac Vasc Anesth. 2009 Dec;23(6):807-12. doi: 10.1053/j.jvca.2009.02.003. Epub 2009 Apr 19.
Devereux RB, Reichek N. Echocardiographic determination of left ventricular mass in man. Anatomic validation of the method. Circulation. 1977 Apr;55(4):613-8. doi: 10.1161/01.cir.55.4.613.
Orsinelli DA, Aurigemma GP, Battista S, Krendel S, Gaasch WH. Left ventricular hypertrophy and mortality after aortic valve replacement for aortic stenosis. A high risk subgroup identified by preoperative relative wall thickness. J Am Coll Cardiol. 1993 Nov 15;22(6):1679-83. doi: 10.1016/0735-1097(93)90595-r.
Other Identifiers
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TantaU
Identifier Type: -
Identifier Source: org_study_id
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