Patient Quality of Recovery After TAVR With Different Sedation Regimens

Part of paid clinical trials in Glenview, Illinois.

Sponsor
David Lyubashevsky
Study ID
NCT07556523
Phase
PHASE4
Status
Recruiting
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Conditions

  • Aortic Valve Stenosis
  • Transcatheter Aortic Valve Replacement (TAVR)

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Propofol — DRUG
    Propofol will be administered intravenously for intraoperative sedation during transcatheter aortic valve replacement (TAVR), with initiation and maintenance infusion dosing of 5-100 mcg/kg/min, titrated to clinical effect according to standard anesthesia practice.
  • Dexmedetomidine — DRUG
    Dexmedetomidine will be administered intravenously for intraoperative sedation during transcatheter aortic valve replacement (TAVR), with initiation and maintenance infusion dosing of 0.2-1.0 mcg/kg/hr, titrated to clinical effect according to standard anesthesia practice.
  • Midazolam — DRUG
    Midazolam will be administered intravenously for intraoperative sedation during TAVR and titrated to achieve adequate sedation and analgesia according to standard anesthesia practice.
  • Fentanyl — DRUG
    Fentanyl will be administered intravenously for intraoperative sedation during TAVR and titrated to achieve adequate sedation and analgesia according to standard anesthesia practice.

Study Details

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

Key Dates

Start date
Mar 16, 2026
Status verified
Apr 2026
Primary completion
Apr 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
126 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Propofol
    Participants will receive propofol for intraoperative sedation during transcatheter aortic valve replacement (TAVR).
  • Experimental: Dexmedetomidine
    Participants will receive dexmedetomidine for intraoperative sedation during transcatheter aortic valve replacement (TAVR).
  • Experimental: Midazolam and Fentanyl
    Participants will receive a combination of midazolam and fentanyl for intraoperative sedation during transcatheter aortic valve replacement (TAVR).

Primary Outcome Measure

Quality of Recovery on Postoperative Day 1 Measured by QoR-15 Survey [ Time Frame: From baseline assessment prior to transcatheter aortic valve replacement (TAVR) through postoperative day 1 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Endeavor HealthGlenviewIllinois60026
Jessica Brickner
[email protected]
847-570-1197
David Lyubashevsky, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Glenview, IL

By research site
Endeavor Health· Glenview, IL

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