126 Participants NeededMy employer runs this trial

Sedation Regimens for TAVR Recovery

JB
NM
Overseen ByNia Moragne
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: David Lyubashevsky
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of 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

Are You a Good Fit for This Trial?

Inclusion Criteria

Consents to participate
I am between 18 and 90 and having transfemoral TAVR with monitored anesthesia.
I can speak English or Spanish.

Exclusion Criteria

Preoperative heart rate < 50 bpm or arrhythmias (e.g., AFib with RVR)
Pulmonary artery pressure > 70mmHg
I cannot give consent in English or Spanish.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo TAVR procedure with one of three sedation regimens (propofol, dexmedetomidine, or midazolam with fentanyl)

1 day
1 visit (in-person)

Immediate Postoperative Monitoring

Participants are monitored in the PACU for recovery and pain management

4 hours
1 visit (in-person)

Follow-up

Participants complete surveys on postoperative days 1 and 7 to assess quality of recovery and satisfaction with anesthesia

1 week
2 visits (virtual)

Extended Follow-up

Participants are monitored for 30-day readmission rates and other postoperative outcomes

30 days

What Are the Treatments Tested in This Trial?

Interventions

  • Dexmedetomidine
  • Fentanyl
  • Midazolam
  • Propofol

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: PropofolExperimental Treatment1 Intervention
Group II: Midazolam and FentanylExperimental Treatment2 Interventions
Group III: DexmedetomidineExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

David Lyubashevsky

Lead Sponsor