Thoracic Epidural Reduces Risks of Increased Left Ventricular Mass Index During Coronary Artery Bypass Graft Surgery

NCT03719248 | Completed

• 1 other identifier: TantaU
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

Ischemia Coronary Artery Origin

Keywords

Epidural.; ventricular mass; Aortic valve; coronary bypass

Outcome Measures

Primary Outcomes (5)

• 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.

• 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.

• 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.

• 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.

• 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 Outcomes (3)

• Perioperative changes in heart rate (HR).

  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

• changes in mean arterial blood pressure (MAP)

  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

• the changes incidence of ischemic ECG.

  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

Study Arms (8)

HTEA Group + N(LVMI)+ AVR alone(n=10)

ACTIVE COMPARATOR

HTEA Group + N(LVMI)+ AVR alone(n=10)

Device: thoracic epidural

HTEA Group + ↑ (LVMI)+ AVR alone(n=10)

ACTIVE COMPARATOR

HTEA Group + ↑ (LVMI)+ AVR alone(n=10)

Device: thoracic epidural

HTEA Group + N(LVMI)+ AVR + CABG(n=10)

ACTIVE COMPARATOR

HTEA Group + N(LVMI)+ AVR + CABG(n=10)

Device: thoracic epidural

HTEA Group +↑ (LVMI)+ AVR + CABG(n=10)

ACTIVE COMPARATOR

HTEA Group +↑ (LVMI)+ AVR + CABG(n=10)

Device: thoracic epidural

Control(GA) Group+ N(LVMI)+ AVR alone(n=10)

NO INTERVENTION

Control(GA) Group+ N(LVMI)+ AVR alone(n=10)

Control(GA) Group+ ↑ (LVMI)+ AVR alone(n=10)

NO INTERVENTION

Control(GA) Group+ ↑ (LVMI)+ AVR alone(n=10)

Control(GA) Group+ N(LVMI)+ AVR + CABG(n=10)

NO INTERVENTION

(GA) Group+ N(LVMI)+ AVR + CABG(n=10)

Control(GA) Group+↑ (LVMI)+ AVR + CABG(n=10)

NO INTERVENTION

Control(GA) Group+↑ (LVMI)+ AVR + CABG(n=10)

Interventions

thoracic epidural DEVICE

high thoracic epidural anesthesia (HTEA) combined with GA, transesophageal, transthoracic echocardiography and Holter ECG

Also known as: high thoracic epidural anesthesia (HTEA) combined with GA, transesophageal and transthoracic echocardiography, Holter ECG

HTEA Group + N(LVMI)+ AVR + CABG(n=10); HTEA Group + N(LVMI)+ AVR alone(n=10); HTEA Group + ↑ (LVMI)+ AVR alone(n=10); HTEA Group +↑ (LVMI)+ AVR + CABG(n=10)

Eligibility Criteria

• Age: 65 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Ahmed Said Elgebaly,MD: lead
• Tanta University: collaborator

Study Sites (1)

Ahmed Said Elgebaly

Tanta, Egypt

Location

Related Publications (10)

• 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.

  PMID: 15920175 RESULT

• 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.

  PMID: 14662525 RESULT

• 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.

  PMID: 2240673 RESULT

• 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.

  PMID: 21239976 RESULT

• 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.

  PMID: 15182113 RESULT

• 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.

  PMID: 23440403 RESULT

• 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.

  PMID: 22412771 RESULT

• 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.

  PMID: 19376734 RESULT

• 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.

  PMID: 138494 RESULT

• 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.

  PMID: 8227838 RESULT

MeSH Terms

Interventions

Echocardiography; Electrocardiography, Ambulatory

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Electrocardiography; Electrodiagnosis; Monitoring, Ambulatory; Monitoring, Physiologic

Study Officials

• ahmed S Elgebaly, MD

  assist .professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: director

Study Record Dates

• First Submitted: October 15, 2018
• First Posted: October 25, 2018
• Study Start: January 1, 2017
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: October 25, 2018

Record last verified: 2018-10

Locations

EG (1)