Clinical Trial: Combined Spinal- Epidural Anesthesia in Patients With Dilated Cardiomyopathy

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Combined Spinal- Epidural Anesthesia (CSE) for Vascular and Orthopedic Operations in Patients With Dilated Cardiomyopathy

Brief Summary:

This study was conducted on 24 patients who have ischemic dilated cardiomyopathy, underwent non cardiac surgery in the lower half of the body under the effect of combined spinal epidural anesthesia at Assiut university hospital. Intraoperative Hemodynamic monitoring including invasive blood pressure, heart rate, and CVP was established, in addition to pre and postoperative, 12 lead ECG, echocardiography, and venous sampling for Brain natriuretic peptide measurement were done .

This study tried to assess the safety of this anesthetic technique on such group of cardiac patients along over the hospital stay period and up to 6 months postoperatively, in addition to the predictability of Brain natriuretic peptide as a cardiac biomarker regarding to the major adverse cardiac events and cardiac mortality for these group of patients .


Detailed Summary:

Dilated cardiomyopathy (DCM) is characterized by ventricular dilatation and impaired systolic cardiac function. Anesthetic management, of patients with cardiomyopathy with reduced systolic function, is challenging and may be associated with high mortality.

Objective: The purpose of this study was to evaluate the hemodynamic effects of combined spinal epidural anesthesia (CSEA) in patients with dilated cardiomyopathy, underwent vascular surgery in the lower half of the body, in addition to assess the safety of this anesthetic technique in the early postoperative period.

Method: After approval by local research ethics committee of the Faculty of Medicine, and informed written consent obtained from all patients, 24 patients having dilated cardiomyopathy, subjected to vascular surgery in the lower half of the body under CSEA. The effects of CSEA on hemodynamics; IBP, HR and CVP (measured at base line and then every 10 min), in addition to cardiac complications during the hospital stay period were studied.


Sponsor: Assiut University

Current Primary Outcome: early postoperative cardiac complications [ Time Frame: 7 days post operative ]

following up the patients for cardiac events such as arrhythmia , heart failure , new ischemic cardiac events


Original Primary Outcome: Same as current

Current Secondary Outcome: BNP level changes [ Time Frame: 72 hours postoperative ]

BNP follow up


Original Secondary Outcome: Same as current

Information By: Assiut University

Dates:
Date Received: March 16, 2016
Date Started: January 2009
Date Completion:
Last Updated: February 9, 2017
Last Verified: February 2017