Combined Spinal- Epidural Anesthesia in Patients With Dilated Cardiomyopathy

NCT ID: NCT03051529

Last Updated: 2017-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2012-12-31

Brief Summary

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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 Description

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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.

Conditions

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Cardiomyopathies

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

combined spinal epidural anesthesia

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Emad Zarief , MD

Lecturer of Anesthesia and critical care Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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IRB00009900

Identifier Type: -

Identifier Source: org_study_id

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