How the type of sedation affects recovery after TAVR
Official title: Patient Quality of Recovery After TAVR With Different Sedation Regimens
Run by Endeavor Health · NCT07556523 · Data updated 2026-11-12
This study will test whether three common sedation approaches (propofol, dexmedetomidine, or midazolam with fentanyl) change how people recover on the first day after transfemoral TAVR.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Enrollment | 126 (estimated) |
| Sponsor | Endeavor Health Academic / other |
| Locations | 1 site (Glenview, Illinois) |
| Status | Recruiting |
| Started | March 16, 2026 |
| Main results expected | April 2028 |
| Study ends | June 2028 |
| Registry record updated | April 29, 2026 |
| Trial ID | NCT07556523 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–90 undergoing transfemoral TAVR under monitored anesthesia care who can consent in English or Spanish and have no contraindications to the study drugs are ideal candidates.
✕Probably not a fit
Patients with preoperative bradycardia or significant arrhythmias, conduction blocks without a pacer, very high pulmonary pressures, morbid obesity, pregnancy, or allergies to the study drugs are excluded and unlikely to benefit from this comparison.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, Phase 4 trial enrolling adults scheduled for transfemoral TAVR under monitored anesthesia care who can consent in English or Spanish. Participants are randomly assigned to receive propofol, dexmedetomidine, or midazolam with fentanyl during the procedure. Researchers collect short patient-reported surveys on postoperative days 1 and 7 about pain, overall recovery experience, and satisfaction with anesthesia. The primary focus is differences in quality of recovery on the first day after the procedure.
Why it matters
Potential benefit: If successful, the results could help clinicians choose a sedation approach that improves early comfort, pain control, and patient satisfaction after TAVR.
How similar studies have gone: Previous research has compared conscious sedation versus general anesthesia for TAVR, but direct randomized comparisons among propofol, dexmedetomidine, and midazolam/fentanyl specifically for day‑one recovery are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Endeavor Health
Glenview, Illinois, United States Recruiting
Study contacts
- Study coordinator: Jessica Brickner
- Email: jessica.brickner@endeavorhealth.org
- Phone: 847-570-1197
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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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.