Patient Quality of Recovery After TAVR With Different Sedation Regimens
Purpose
The goal of this clinical trial is to learn whether the type of sedation medication used during a transcatheter aortic valve replacement (TAVR) affects how people recover after the procedure. The main question this study aims to answer is whether different sedation regimens (propofol, dexmedetomidine, or midazolam with fentanyl) lead to differences in quality of recovery on the first day after the procedure. Researchers will compare three commonly used sedation medications (propofol, dexmedetomidine, or midazolam with fentanyl) to determine whether they lead to differences in recovery following a TAVR. Participants will: - Be enrolled before their scheduled TAVR procedure - Be randomly assigned to receive one of the three sedation medications during their procedure - Complete short surveys on postoperative days 1 and 7 about pain levels, how they feel during their recovery, and how satisfied they were with their anesthesia experience
Conditions
- Transcatheter Aortic Valve Replacement (TAVR)
- Aortic Valve Stenosis
Eligibility
- Eligible Ages
- Between 18 Years and 90 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 18-90 years old, inclusive - Undergoing transfemoral TAVR under Monitored Anesthesia Care (MAC) - Speaks English or Spanish - Consents to participate
Exclusion Criteria
- Preoperative heart rate < 50 bpm or arrhythmias (e.g., AFib with RVR) - Conduction abnormalities (e.g., 2nd/3rd degree AV block without pacer) - Allergy or contraindication to study drugs - Pulmonary artery pressure > 70mmHg - Morbid obesity BMI > 50 - Pregnancy - Unable to consent in English or Spanish
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Participants will be randomized to one of three anesthetic regimen cohorts in a 1:1:1 ratio: dexmedetomidine (with option for midazolam/fentanyl) or propofol infusion (with option for midazolam and fentanyl) or midazolam/fentanyl alone.
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
- Masking Description
- The clinical team, including the cardiologist, nurses, and other staff, will be blinded to the treatment.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Propofol |
Participants will receive propofol for intraoperative sedation during transcatheter aortic valve replacement (TAVR). |
|
|
Experimental Dexmedetomidine |
Participants will receive dexmedetomidine for intraoperative sedation during transcatheter aortic valve replacement (TAVR). |
|
|
Experimental Midazolam and Fentanyl |
Participants will receive a combination of midazolam and fentanyl for intraoperative sedation during transcatheter aortic valve replacement (TAVR). |
|
Recruiting Locations
Glenview, Illinois 60026
More Details
- NCT ID
- NCT07556523
- Status
- Recruiting
- Sponsor
- David Lyubashevsky