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Patient Quality of Recovery After TAVR With Different Sedation Regimens

RECRUITINGPhase 4Sponsored by David Lyubashevsky
Actively Recruiting
PhasePhase 4
SponsorDavid Lyubashevsky
Started2026-03-16
Est. completion2028-04
Eligibility
Age18 Years – 90 Years
Healthy vol.Accepted
Locations1 site

Summary

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

Eligibility

Age: 18 Years – 90 YearsHealthy volunteers accepted
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

Conditions3

Aortic Valve StenosisHeart DiseaseTranscatheter Aortic Valve Replacement (TAVR)

Interventions4

Locations1 site

Endeavor Health
Glenview, Illinois, 60026
Jessica Brickner847-570-1197jessica.brickner@endeavorhealth.org

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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