How the type of sedation affects recovery after TAVR
Patient Quality of Recovery After TAVR With Different Sedation Regimens
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 |
| Enrollment | 126 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Endeavor Health Academic / other |
| Locations | 1 site (Glenview, Illinois) |
| Trial ID | NCT07556523 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Glenview, Illinois
- Endeavor Health — Glenview, Illinois, United States (Recruiting)
Study contacts
- Study coordinator: Jessica Brickner
- Email: jessica.brickner@endeavorhealth.org
- Phone: 847-570-1197
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.