drugset / Trial / NCT07556523

Patient Quality of Recovery After TAVR With Different Sedation Regimens

NCT07556523

Phase 4 Recruiting 126 enrolled David Lyubashevsky
RandomizedParallel-groupDouble-blindTreatment

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

Timeline

Start
2026-03-16
Primary completion
2028-04
Completion
2028-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexmedetomidine Other / unclassified 0.2 ug/kg Intravenous
Subject Dexmedetomidine Other / unclassified 1 ug/kg Intravenous
Subject Fentanyl Other / unclassified Intravenous
Subject Midazolam Small molecule Intravenous
Subject Propofol Small molecule 5 ug/kg Intravenous
Subject Propofol Small molecule 100 ug/kg Intravenous

Indications