Actively Recruiting
Patient Quality of Recovery After Transcatheter Aortic Valve Replacement With Different Sedation Medications
Led by David Lyubashevsky · Updated on 2026-04-29
126
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial is investigating whether different sedation medications used during transcatheter aortic valve replacement (TAVR) affect patients' recovery quality. The main focus is to compare three sedation regimens—propofol, dexmedetomidine, and midazolam with fentanyl—and assess how they influence recovery on the first day after the procedure. The study aims to understand which sedation approach may lead to better postoperative outcomes in adults undergoing TAVR. Participants will be randomly assigned to receive one of the three sedation medications during their TAVR procedure. Propofol will be given intravenously at doses titrated to effect, dexmedetomidine will be administered via infusion adjusted similarly, and a combination of midazolam and fentanyl will be used to achieve sedation and pain relief. The sedation is administered during the procedure under monitored anesthesia care. Throughout the study, participants will complete surveys about their pain levels, overall recovery experience, and satisfaction with anesthesia on postoperative days 1 and 7. Researchers will also monitor heart rate changes, length of hospital stay, postoperative delirium, incidence of complications, and other recovery-related outcomes up to 30 days after the procedure. This allows comprehensive assessment of recovery quality and safety following different sedation methods.
CONDITIONS
Brief Title
Patient Quality of Recovery After TAVR With Different Sedation Regimens
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 90 years, inclusive
- Undergoing transfemoral transcatheter aortic valve replacement (TAVR) under monitored anesthesia care
- Able to speak English or Spanish
- Willing and able to provide informed consent
You will not qualify if you...
- Preoperative heart rate less than 50 beats per minute or arrhythmias such as atrial fibrillation with rapid ventricular response
- Presence of conduction abnormalities like 2nd or 3rd degree AV block without pacemaker
- Allergy or contraindication to any of the study sedation drugs
- Pulmonary artery pressure greater than 70 mmHg
- Morbid obesity with body mass index over 50
- Pregnancy
- Unable to provide consent in English or Spanish
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of TAVR procedure
Participants receive intraoperative sedation with either propofol, dexmedetomidine, or a combination of midazolam and fentanyl during transcatheter aortic valve replacement (TAVR).
1 visit (procedure day)
Duration - Up to 30 days after the procedure
Participants are assessed for recovery quality, pain, satisfaction with anesthesia, delirium, and other clinical outcomes after the TAVR procedure.
Visits on postoperative day 1, postoperative day 7, and hospital discharge
Trial Site Locations
Total: 1 location
1
Endeavor Health
Glenview, Illinois, United States, 60026
Actively Recruiting
Research Team
J
Jessica Brickner
N
Nia Moragne
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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