Combined Spinal- Epidural Anesthesia in Patients With Dilated Cardiomyopathy

• ClinicalTrials.gov Identifier: NCT03051529
• Recruitment Status: Completed
• First Posted: February 13, 2017
• Last Update Posted: February 13, 2017
• Sponsor: Assiut University
• Information provided by (Responsible Party): Emad Zarief , MD, Assiut University

Study Description

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 .

Condition or disease	Intervention/treatment
Cardiomyopathies	Other: combined spinal epidural anesthesia

Detailed Description:

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 Design

• Study Type: Observational
• Actual Enrollment: 24 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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

Groups and Cohorts

Group/Cohort	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. BNP level changes [ Time Frame: 72 hours postoperative ]
   BNP follow up

Eligibility Criteria

• Ages Eligible for Study: 30 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

24 patients having dilated cardiomyopathy, subjected to vascular surgery in the lower half of the body under combined spinal epidural anesthesia CSEA.

Criteria

Inclusion Criteria:

• 24 patients Cardiomyopathy DCM underwent infra-inguinal vascular surgery under the effect of combined spinal epidural technique were included in a prospective trial single center observational study.

Exclusion Criteria:

• Patients with significant fluid and electrolyte imbalance, major arrhythmias or heart failure or unstable angina, systolic blood pressure at rest < 100 mmHg, heart rate < 50, serum creatinine >2.0 mg /dl, and patients who required emergency surgery were excluded from the study.

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Emad Zarief , MD, Lecturer of Anesthesia and critical care Medicine, Assiut University
• ClinicalTrials.gov Identifier: NCT03051529
• Other Study ID Numbers: IRB00009900
• First Posted: February 13, 2017
• Last Update Posted: February 13, 2017
• Last Verified: February 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Cardiomyopathies; Cardiomyopathy, Dilated; Heart Diseases; Cardiovascular Diseases; Cardiomegaly; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs