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Recovery After TAVR With Different Sedation Regimens

This study is looking at how different sedation medications affect your recovery after a transcatheter aortic valve replacement (TAVR) procedure. Researchers want to see if using propofol, dexmedetomidine, or a combination of midazolam and fentanyl for sedation changes how well you recover on the first day after your TAVR. You might be able to join if you are between 18 and 90 years old, are having a TAVR under monitored anesthesia care, and speak English or Spanish. The study is currently unclear about its recruitment status and plans to enroll 126 participants. The main goal is to measure your quality of recovery using a survey on the day after your procedure.

Study design
This interventional study plans to enroll 126 participants. It compares three different sedation regimens: propofol, dexmedetomidine, or midazolam with fentanyl.
What's involved
You would receive one of the study's sedation medications during your TAVR procedure. Your quality of recovery will be assessed using a survey on the first day after your procedure.
Compensation
Not stated in the trial record.
Follow-up
Your recovery will be assessed from before your TAVR through the first day after the procedure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07556523

Patient Quality of Recovery After TAVR With Different Sedation Regimens

Recruiting
PHASE4Ages 18–90InterventionalTreatment
David Lyubashevsky
~126 participants
Updated 2026-04-29 on ClinicalTrials.gov
What's tested:PropofolDexmedetomidineMidazolamFentanyl

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Quality of Recovery on Postoperative Day 1 Measured by QoR-15 Survey
Measured over From baseline assessment prior to transcatheter aortic valve replacement (TAVR) through postoperative day 1

Conditions

Transcatheter Aortic Valve Replacement (TAVR)
Aortic Valve Stenosis

Explore related trials

Aortic Valve Stenosis

Where it's being run

1 sites across 1 states
Illinois1

Who to contact

Jessica Brickner
[email protected]
847-570-1197
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

18-90 years old, inclusive
Undergoing transfemoral TAVR under Monitored Anesthesia Care (MAC)
Speaks English or Spanish
Consents to participate

Exclusion

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

What this trial measures

  • Quality of Recovery on Postoperative Day 1 Measured by QoR-15 SurveyFrom baseline assessment prior to transcatheter aortic valve replacement (TAVR) through postoperative day 1

    The primary outcome of the study will be the quality of recovery, as measured by the Quality of Recovery-15 (QoR-15) score. A baseline QoR-15 survey will be taken before or on the day of the procedure, and the resulting aggregate score will be compared to the score from the QoR-15 survey completed on post-operative day 1 (POD 1). The QoR-15 survey is 15-item questionnaire which has a scale of 0-10 pertaining to a patient's comfort, support system, pain, well-being, and ability to carry out daily activities. For questions 1-10, number "0" indicates none of the time and number "10" indicates all of the time. For questions 11-15, number "0" indicates all of the time and number "10" indicates none of the time. A higher overall score indicates a better outcome (i.e. better quality of recovery) and a lower score indicates a worse outcome (i.e. poorer quality of recovery).