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Spinal anesthesia studied in heart valve surgery patients

NCT ID NCT06156592

Knowledge-focused Sponsor: University of Manitoba Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at how spinal anesthesia changes blood flow and heart function in 44 patients with severe aortic stenosis or mitral regurgitation during valve replacement surgery. Researchers measured the need for drugs that support blood pressure and heart function, as well as heart performance on ultrasound. The goal was to compare these effects between the two heart valve conditions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
high spinal anesthesia (bupivacaine, fentanyl, epimorphine)
What this could lead to
If successful, this could help doctors choose safer anesthesia methods for heart valve surgery patients.
What could go wrong
This is a small, completed observational study, not a treatment trial. Results may not apply to all patients or change current practice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

44 people

The number who actually took part.

Started

Nov 2023

Finished

Oct 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adult patients admitted to St. Boniface Hospital, Winnipeg, Canada, a tertiary care hospital, for elective aortic or mitral valve repair over the period Oct 2023 to December 2025.

Ages

18 years and older

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis mitral valve insufficiency

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Severe aortic valve stenosis Severe mitral valve regurgitation

Contacts and locations

Locations

  • Department of Anesthesiology, Perioperative and Pain Medicine, SBGH

    Winnipeg, Manitoba, R2H 2A6, Canada

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