Combined Spinal- Epidural Anesthesia in Patients With Dilated Cardiomyopathy

Sponsor
Assiut University (Other)
Overall Status
Completed
CT.gov ID
NCT03051529
Collaborator
(none)
24
47

Study Details

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 Phase
  • 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 :
Jan 1, 2009
Actual Primary Completion Date :
Dec 1, 2012
Actual Study Completion Date :
Dec 1, 2012

Arms and Interventions

Arm 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 [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 [72 hours postoperative]

    BNP follow up

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Feb 13, 2017
Last Update Posted:
Feb 13, 2017
Last Verified:
Feb 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 13, 2017