NCT07556523 · David Lyubashevsky
Patient Quality of Recovery After TAVR With Different Sedation Regimens
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
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.
DRUG
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.
DRUG
Midazolam
Midazolam will be administered intravenously for intraoperative sedation during TAVR and titrated to achieve adequate sedation and analgesia according to standard anesthesia practice.
DRUG
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 measures
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
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Unable to consent in English or Spanish
Where
- Glenview, Illinois
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
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Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 29, 2026 · Source of record for eligibility and locations