Comparing sedation methods for heart valve replacement
Comparative Study of Propofol Versus Dexmedetomidine for Conscious Sedation During Transcatheter Aortic Valve Implantation
NA · University of Ioannina · NCT05462938
This study tests whether using propofol or dexmedetomidine for sedation during heart valve replacement helps patients feel more comfortable and have better health outcomes.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Ioannina (other) |
| Locations | 1 site (Ioannina, Epirus) |
| Trial ID | NCT05462938 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of two sedation methods, propofol and dexmedetomidine, during Transcatheter Aortic Valve Replacement (TAVR) procedures. It aims to determine which method provides better sedation quality and clinical outcomes for patients undergoing this less invasive heart valve treatment. Patients scheduled for TAVR will be randomly assigned to receive either sedation method, and their experiences and health outcomes will be monitored. The study addresses the growing need for safer anesthesia options in elderly patients with aortic stenosis who may have multiple health issues.
Who should consider this trial
Good fit: Ideal candidates are patients scheduled for Transcatheter Aortic Valve Replacement (TAVR).
Not a fit: Patients requiring emergency operations or those with severe cognitive dysfunction or end-stage renal disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved sedation practices during TAVR, enhancing patient safety and satisfaction.
How similar studies have performed: Previous studies have shown promising results for conscious sedation in similar procedures, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients scheduled for TAVR Exclusion Criteria: * Emergency operation * Pre-existing neurocognitive dysfunction (Mini Mental State Examination score \<23) * Inability to cooparate - communicate * End Stage Renal Disease * Allergy to any of the administrated drugs * No consent
Where this trial is running
Ioannina, Epirus
- Univesity Hospital of Ioannina — Ioannina, Epirus, Greece (RECRUITING)
Study contacts
- Principal investigator: Paraskevas Tseniklidis, MD — University of Ioannina
- Study coordinator: Agathi Karakosta, MD, PhD
- Email: akarakosta@uoi.gr
- Phone: 0030 6948066243
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.
Conditions: Renal Function Disorder, Postoperative Delirium, Adverse Event, Death, Satisfaction, transcatheter aortic valve replacement, dexmedetomidine, propofol