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Purpose

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

Conditions

Eligibility

Eligible Ages
Between 18 Years and 90 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 - Pregnancy - Unable to consent in English or Spanish

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Participants will be randomized to one of three anesthetic regimen cohorts in a 1:1:1 ratio: dexmedetomidine (with option for midazolam/fentanyl) or propofol infusion (with option for midazolam and fentanyl) or midazolam/fentanyl alone.
Primary Purpose
Treatment
Masking
Double (Participant, Care Provider)
Masking Description
The clinical team, including the cardiologist, nurses, and other staff, will be blinded to the treatment.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Propofol 		Participants will receive propofol for intraoperative sedation during transcatheter aortic valve replacement (TAVR).
  • 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.
Experimental
Dexmedetomidine 		Participants will receive dexmedetomidine for intraoperative sedation during transcatheter aortic valve replacement (TAVR).
  • 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.
Experimental
Midazolam and Fentanyl 		Participants will receive a combination of midazolam and fentanyl for intraoperative sedation during transcatheter aortic valve replacement (TAVR).
  • 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.

Recruiting Locations

Endeavor Health
Glenview, Illinois 60026
Contact:
Jessica Brickner
847-570-1197
jessica.brickner@endeavorhealth.org

More Details

Status
Recruiting
Sponsor
David Lyubashevsky

Study Contact

Jessica Brickner
847-570-1197
jessica.brickner@endeavorhealth.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.