Recruiting

Propofol, Dexmedetomidine, Midazolam with Fentanyl

Sponsor:

David Lyubashevsky

Code:

NCT07556523

Conditions

Transcatheter Aortic Valve Replacement (TAVR)

Aortic Valve Stenosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Propofol

Dexmedetomidine

Midazolam

Fentanyl

Study Details

Brief 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

Conditions

Transcatheter Aortic Valve Replacement (TAVR)

Aortic Valve Stenosis

Study ID

NCT07556523

Start date

Mar 16, 2026

Status verified date

Apr, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not 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

Study Design

Enrollment

126 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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).

Interventions

Propofol

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

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

Midazolam will be administered intravenously for intraoperative sedation during TAVR and titrated to achieve adequate sedation and analgesia according to standard anesthesia practice.

Fentanyl

Fentanyl will be administered intravenously for intraoperative sedation during TAVR and titrated to achieve adequate sedation and analgesia according to standard anesthesia practice.

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 and Locations

Central contacts

Jessica Brickner

847-570-1197jessica.brickner@endeavorhealth.org

Nia Moragne

847-570-1197nia.moragne@endeavorhealth.org

Locations

Endeavor Health

Recruiting

Glenview, Illinois, United States, 60026

Contacts

Jessica Brickner

847-570-1197jessica.brickner@endeavorhealth.org

Principal Investigator:

David Lyubashevsky, MD

More Information

Sponsor

David Lyubashevsky

Last update posted

Apr 29, 2026

Last verified

Apr, 2026

Keywords

  • Transcatheter aortic valve replacement
  • TAVR
  • Sedation strategy
  • Anesthesia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by David Lyubashevsky on 2026-04-29.