Assessing hemodynamic changes after spinal anesthesia in patients with severe heart valve issues
Prospective Observational Study to Compare Hemodynamic Alterations in Severe Aortic Stenosis and Severe Mitral Regurgitation After High Spinal Anesthesia in Patients Undergoing Aortic Valve and Mitral Valve Replacement Surgery
This study is testing how spinal anesthesia affects blood flow and heart function in patients with serious heart valve problems during surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Manitoba Academic / other |
| Locations | 1 site (Winnipeg, Manitoba) |
| Trial ID | NCT06156592 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the hemodynamic changes that occur after spinal anesthesia in patients with severe aortic stenosis or mitral regurgitation undergoing valve replacement surgery. It focuses on the requirements for vasopressors and variations in echocardiographic parameters post-anesthesia. The study aims to clarify the physiological effects of spinal anesthesia, challenging traditional theories regarding its impact on cardiac output and blood pressure. By gathering real-time evidence, the study seeks to provide insights into the safety and efficacy of spinal anesthesia in these high-risk patients.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with severe aortic stenosis or mitral regurgitation who are undergoing elective valve repair or replacement and are eligible for spinal anesthesia.
Not a fit: Patients with contraindications to spinal anesthesia, severe spine disorders, or those requiring complex surgical interventions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the management of anesthesia in patients with severe heart valve conditions, potentially leading to better surgical outcomes.
How similar studies have performed: While there is limited real-time evidence specifically addressing this approach, previous studies have explored the effects of spinal anesthesia in cardiac patients, indicating a need for further investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All patients over 18 years of age, irrespective of their gender or ASA physical status * With severe aortic stenosis or mitral regurgitation * Undergoing elective aortic or mitral valve repair or replacement * Eligible for spinal anesthesia up to T1-2 level block for their surgical procedure. * Able to provide written informed consent Exclusion Criteria: * Contraindications to the administration of spinal anesthesia such as pre-existing coagulopathy, local sepsis at the site of insertion * Hypoxic (SaO2 \< 95%) on room air * Unable to lie flat and with 15-degree trendelenburg * The apical four and five chamber window is not accessible on trans-thoracic echocardiography * Difficult airway requiring awake intubation * On dialysis * Redo-valve surgery * Mixed valvular lesions (more than mild AR or MS) * Requiring more than one CABG or CPB duration more than 180 minutes * More than 3 segment Regional Wall Motion Abnormalities * Severe spine disorders
Where this trial is running
Winnipeg, Manitoba
- Department of Anesthesiology, Perioperative and Pain Medicine, SBGH — Winnipeg, Manitoba, Canada (Recruiting)
Study contacts
- Principal investigator: Virendra Arya, MD, FRCPC — SBGH, University of Manitoba, Winnipeg, Canada
- Study coordinator: Virendra Arya, MD, FRCPC
- Email: varya@sbgh.mb.ca
- Phone: 204 235-3659
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.