Combined Spinal- Epidural Anesthesia in Patients With Dilated Cardiomyopathy
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|ClinicalTrials.gov Identifier: NCT03051529|
Recruitment Status : Completed
First Posted : February 13, 2017
Last Update Posted : February 13, 2017
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 .
|Condition or disease||Intervention/treatment|
|Cardiomyopathies||Other: combined spinal epidural anesthesia|
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.
|Study Type :||Observational|
|Actual Enrollment :||24 participants|
|Official Title:||Combined Spinal- Epidural Anesthesia (CSE) for Vascular and Orthopedic Operations in Patients With Dilated Cardiomyopathy|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
combined spinal epidural
24 patients with dilated cardiomyopathy undergoing vascular surgery in the lower half of the body under combined spinal epidural anesthesia will be enrolled in the study
Other: combined spinal epidural anesthesia
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
- 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
- BNP level changes [ Time Frame: 72 hours postoperative ]BNP follow up