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 range18 Years

SexALL

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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

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