About this trial

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 criteria

Qualifiers

18-90 years old, inclusive

Undergoing transfemoral TAVR under Monitored Anesthesia Care (MAC)

Speaks English or Spanish

Consents to participate

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Propofol
  • Dexmedetomidine
  • Midazolam
  • Fentanyl

Treatment groups

126 Participants
are divided into 3 treatment groups

Locations

1
Endeavor Health60026, GlenviewIllinois, United States

Sponsors and collaborators

David Lyubashevsky

Lead sponsor

Endeavor Health

Sponsor institution