Status:
COMPLETED
Post Spinal Hemodynamic Changes in Aortic Stenosis and Mitral Regurgitation by VIS Index and Echocardiography
Lead Sponsor:
University of Manitoba
Conditions:
Severe Aortic Valve Stenosis
Severe Mitral Valve Regurgitation
Eligibility:
All Genders
18+ years
Brief 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 aor...
Detailed Description
Spinal anesthesia (SA) involves injecting local anesthetic into the intrathecal space. Since it was first described, understanding of the physiology and pharmacology of drugs acting within the subarac...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 26 2025
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT06156592
Start Date
November 1 2023
End Date
October 26 2025
Last Update
January 6 2026
Active Locations (1)
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1
Department of Anesthesiology, Perioperative and Pain Medicine, SBGH
Winnipeg, Manitoba, Canada, R2H 2A6