CompletedNot Applicable

Post Spinal Hemodynamic Changes in Aortic Stenosis and Mitral Regurgitation by VIS Index and Echocardiography

Canada44 participantsStarted 2023-11-01

Plain-language summary

This study will assess hemodynamic changes induced after spinal anesthesia by evaluating vasopressor inotropic requirements and variations in echocardiographic parameters in patients having severe aortic stenosis or severe mitral regurgitation undergoing aortic or mitral valve replacement surgery.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To compare total inotropic, inodilators and vasopressor drug requirements by calculating the vasoactive-inotropic score (VIS) Index to maintain target stable hemodynamics in both groups

Timeframe: From spinal drug injection to the starting of cardiopulmonary bypass (CPB), during CPB surgery and post CPB up to the time when patient leaves operation room

To compare changes in right and left ventricular myocardial performance index (Tei) in both groups

Timeframe: Baseline pre-spinal, 2 minutes post spinal flat supine, 5 min post spinal trendelenburg 15 degree,10 minutes post general anesthesia at opening CVP pressure in trendelenburg 15 degree, 2 minute post surgical position flat supine with 5 degree back up

To compare changes in Left Ventricular Outflow Tract (LVOT) Cardiac Index (CI) in both groups

Trial details

NCT IDNCT06156592

SponsorUniversity of Manitoba

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-10-26

View on ClinicalTrials.gov More Severe Aortic Valve Stenosis trials