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?

This trial explores how different sedation medications used during transcatheter aortic valve replacement (TAVR) impact recovery. Researchers compare three sedation options—propofol, dexmedetomidine, and a combination of midazolam with fentanyl—to determine which might enhance the recovery experience immediately after the procedure. Ideal participants are those scheduled for a TAVR who can communicate in English or Spanish and have agreed to participate in the study. As a Phase 4 trial, the sedation options are already FDA-approved and proven effective, and this research aims to understand how they benefit more patients.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for these sedation regimens?

Previous studies have shown that propofol does not significantly differ in surgery or recovery outcomes compared to other sedatives for TAVR patients. However, it may cause more instances of low blood oxygen levels than other options.

Dexmedetomidine reduces confusion after surgery but may lead to low blood pressure and a slow heart rate. Despite these risks, it remains a good alternative with results similar to propofol.

Research indicates that using midazolam and fentanyl in TAVR is safe, typically not leading to major complications during the procedure.

All three sedation options are commonly used and generally well-tolerated, though each has potential side effects.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these sedation regimens for TAVR recovery because they offer diverse approaches to patient care during surgery. Unlike traditional sedation methods, which often rely heavily on a single agent, this trial explores the use of propofol, dexmedetomidine, and a combination of midazolam and fentanyl. Propofol is known for its rapid onset and short recovery time, making it ideal for surgeries where quick patient recovery is crucial. Dexmedetomidine provides sedation with less respiratory depression, which can be safer for patients with specific health concerns. Meanwhile, the combination of midazolam and fentanyl offers a synergistic effect that enhances sedation while managing pain effectively. Each regimen offers unique benefits that could potentially improve patient outcomes and safety during TAVR procedures.

What evidence suggests that this trial's sedation regimens could be effective for TAVR recovery?

This trial will compare different sedation regimens for transcatheter aortic valve replacement (TAVR) recovery. Participants in one arm will receive propofol, which studies have shown to be both effective and safe for TAVR procedures. Another arm will use dexmedetomidine, which research suggests may reduce the risk of delayed brain function recovery compared to propofol, while maintaining similar safety and effectiveness. A third arm will involve a combination of midazolam and fentanyl, which has been used successfully, though it doesn't show a significant difference in recovery compared to other sedation methods. Overall, light sedation (conscious sedation) during TAVR is linked to better recovery than full unconsciousness (general anesthesia).46789

Are You a Good Fit for This Trial?

This trial is for adults aged 18-90 who are scheduled for a transcatheter aortic valve replacement (TAVR) using monitored anesthesia care and can speak English or Spanish. People with certain heart problems, very high lung pressure, severe obesity, pregnancy, allergies to study drugs, or unable to consent can't join.

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

Trial Overview

The study compares three sedation approaches—propofol alone, dexmedetomidine alone, or midazolam combined with fentanyl—used during TAVR. Participants are randomly assigned one of these regimens to see which leads to better recovery quality after the procedure.

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

Citations

A Narrative Review on Current Status of Conscious Sedation ...

In this narrative review, all aspects of sedation in TAVI are presented and analyzed, including methods, patient selection, contraindications, ...

Comparison of Procedural Sedation With Propofol and ...

Compared with propofol, procedural sedation with dexmedetomidine in TAVR was associated with a significantly lower incidence of delayed neurocognitive recovery.

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/32297286/

Use of Dexmedetomidine in Transfemoral Transcatheter ...

Conclusion: In this series, sedation with dexmedetomidine for TAVI procedures with femoral access was proven effective and safe. Dexmedetomidine may be a valid ...

Effects of remimazolam versus dexmedetomidine ...

This study evaluated the timely recovery rates of remimazolam and dexmedetomidine after TAVR and compared the associated recovery profiles.

Comparison of Procedural Sedation With Propofol and ...

If untreated it carries a poor prognosis, leading to heart failure and death in 2 years after first symptom presentation. Treatment of choice for severe aortic ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/PMC11467503

a propensity score-matched, non-inferiority study

Conclusions: In patients undergoing TAVR under MAC, remimazolam was non-inferior to dexmedetomidine in terms of timely recovery. Remimazolam may be associated ...

374: effect of intraoperative dexmedetomidine on outcomes ...

Conclusion: Intraoperative use of dexmedetomidine in patients undergoing TAVR was associated with shorter length of stay, which may be partly attributed to the ...

Association of Dexmedetomidine Use With Complete Heart ...

Dexmedetomidine (DEX) reduces postoperative delirium but is associated with hypotension, bradycardia, and conduction abnormalities. To date, DEX ...

Cardiorespiratory Stability of Patients Undergoing ...

A total of 206 TAVR patients were studied. Of these, 150 patients underwent TAVR via the transfemoral approach and were included for comparative analysis. In ...