Dexmedetomidine conscious sedation to protect breathing and blood pressure during TAVI
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Erasme University Hospital Academic / other |
| Locations | 1 site (Brussels) |
| Trial ID | NCT07532733 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients aged 60 or older undergoing transfemoral TAVI under conscious sedation who can provide informed consent and speak French.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Brussels
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.