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Patient Quality of Recovery After TAVR With Different Sedation Regimens

RecruitingPhase 4Ages 18 Years - 90 YearsAllDavid Lyubashevsky
NCT07556523 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 sa

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📋 Eligibility rules (as published)
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
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What it tests

  • Propofol
  • Dexmedetomidine
  • Midazolam
  • Fentanyl
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Where

1 site
Endeavor Health
Glenview, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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