Dexmedetomidine conscious sedation to protect breathing and blood pressure during TAVI
Official title: Respiratory and Haemodynamic Effects Comparison of Conscious Sedation With Dexmedetomidine Versus Sedation With Remifentanil-propofol for a TAVI Procedure: a Prospective, Randomised, Single-blind Study
Run by Erasme University Hospital · NCT07532733 · Data updated 2026-11-12
This trial will test whether dexmedetomidine used for conscious sedation during transfemoral TAVI helps reduce breathing problems and unstable blood pressure in patients aged 60 and over.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 60 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Erasme University Hospital Academic / other |
| Locations | 1 site (Brussels) |
| Status | Recruiting |
| Started | April 22, 2026 |
| Main results expected | May 30, 2027 |
| Study ends | June 30, 2027 |
| Registry record updated | April 30, 2026 |
| Trial ID | NCT07532733 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients aged 60 or older undergoing transfemoral TAVI under conscious sedation who can provide informed consent and speak French.
✕Probably not a fit
Patients who require conversion to general anaesthesia, have contraindications to dexmedetomidine, present major haemodynamic instability, or cannot communicate in French are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Older patients undergoing transfemoral TAVI often receive conscious sedation to avoid risks of general anaesthesia, but commonly used agents like propofol plus opioids can depress breathing. This interventional comparison gives some patients dexmedetomidine and others propofol with remifentanil, monitoring intraoperative respiratory events (bradypnoea, oxygen desaturation, airway obstruction) and haemodynamic stability. Participants are aged 60 or older, managed without general anaesthesia, able to consent, and must have sufficient French for cognitive testing. The main outcomes are the frequency and severity of respiratory and haemodynamic disturbances during the procedure.
Why it matters
Potential benefit: If successful, using dexmedetomidine could lower the risk of respiratory depression and unstable blood pressure during TAVI, improving safety and recovery for older patients.
How similar studies have gone: Dexmedetomidine has been shown in other surgical and sedation settings to cause less respiratory depression than propofol–opioid regimens, but evidence specifically in TAVI populations is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * -aged 60 or over, * undergoing transfemoral TAVI, * treated under sedation without general anaesthesia, * having given their written informed consent, * with sufficient command of French to undertake cognitive tests. Exclusion Criteria: * whose first language is not English, * who have a contraindication to dexmedetomidine, * who require conversion to general anaesthesia during the procedure, * or who present with major haemodynamic instability (shock, uncontrolled arrhythmia).
Where it's running
-
HUB Erasme
Brussels, Belgium Recruiting
Study contacts
- Principal investigator: celine Boudart — HUB - Erasme
- Study coordinator: Celine Boudart, MD PhD
- Email: celine.boudart@hubruxelles.be
- Phone: +3225553919
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.