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Combined Spinal- Epidural Anesthesia in Patients With Dilated Cardiomyopathy

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03051529
Enrollment
24
Registered
2017-02-13
Start date
2009-01-31
Completion date
2012-12-31
Last updated
2017-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiomyopathies

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 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.

Interventions

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
30 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
early postoperative cardiac complications7 days post operativefollowing up the patients for cardiac events such as arrhythmia , heart failure , new ischemic cardiac events

Secondary

MeasureTime frameDescription
BNP level changes72 hours postoperativeBNP follow up

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026