CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 44 enrolled
Drug / intervention
Cardiac valve replacement surgery under high spinal anesthesia combined with light general anesthesiaprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06156592
NCT06156592N/ACompleted

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

University of Manitoba·observational·Posted Dec 5, 2023·Updated Jan 6, 2026

In Brief

An observational study evaluating Cardiac valve replacement surgery under high spinal anesthesia combined with light general anesthesia for Severe Aortic Valve Stenosis and Severe Mitral Valve Regurgitation. Completed, enrolled 44 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesCanada
Collaborators--

Timeline

N/ACompletedFinished
202420252026
First PostedDec 5, 2023
Enrollment StartNov 1, 2023
Primary CompletionOct 26, 2025
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 2.6 years ago

Interventions

Cardiac valve replacement surgery under high spinal anesthesia combined with light general anesthesiaprocedure

Before induction of general anesthesia, a high spinal anesthesia will be given using 37.5 mg of 0.75% heavy bupivacaine with 20 mcg fentanyl and 250 mcg epimorphine in sitting position at the lumbar intervertebral spaces between the L2-3 or L3-4 vertebrae. Patients will lie supine immediately afterwards, and sensory loss to ice will be performed every 15 seconds. Subsequently, the patient will be placed in 15-degree Trendelenburg (ensured by clinometer). Following general anesthesia will be induced and trachea will be intubated after 5 ml of 4% lignocaine spray on vocal cords and trachea. Hemodynamics will be aimed at MAP between 65-100 mmHg and heart rate between 50-100 beats /min by use of various inotropic, inodilators and vasoactive cardiac drugs based on anesthesiologists' clinical judgement.