Patient Quality of Recovery After TAVR With Different Sedation Regimens

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

Study Overview

• Status: Recruiting
• Conditions: Aortic Valve Stenosis; Transcatheter Aortic Valve Replacement (TAVR)
• Intervention / Treatment: Drug: Propofol; Drug: Dexmedetomidine; Drug: Midazolam; Drug: Fentanyl

• Study Type: Interventional
• Enrollment (Estimated): 126
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jessica Brickner; Phone Number: 847-570-1197; Email: jessica.brickner@endeavorhealth.org
• Study Contact Backup: Name: Nia Moragne; Phone Number: 847-570-1197; Email: nia.moragne@endeavorhealth.org

Study Locations

• United States
  • Illinois
    • Glenview, Illinois, United States, 60026
      • Recruiting
      • Endeavor Health
      • Contact: Jessica Brickner; Phone Number: 847-570-1197; Email: jessica.brickner@endeavorhealth.org
      • Principal Investigator: David Lyubashevsky, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Recovery on Postoperative Day 1 Measured by QoR-15 Survey	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).	From baseline assessment prior to transcatheter aortic valve replacement (TAVR) through postoperative day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate Change	Change in heart rate from baseline to nadir intraoperatively and at Post-Anesthesia Care Unit (PACU) admission.	Intraoperative period through PACU admission
Length of Stay	PACU length of stay and total hospital length of stay	From date of procedure through hospital discharge (up to 30 days after procedure date, whichever comes first)
Patient Satisfaction with Anesthesia Measured by 5-Point Likert Scale	Patient-reported satisfaction with anesthesia measured using a 5-point Likert scale. Patients will respond to this statement: The anesthesia care I received during my transcatheter aortic valve replacement (TAVR) procedure met my expectations (5 = Strongly Agree; 1 = Strongly Disagree).	Postoperative day 1 and postoperative day 7
Pain Scores Measured by Visual Analog Scale (VAS)	Pain severity measured using the Visual Analog Scale (VAS).	Upon post-anesthesia care unit (PACU) arrival (within ~2 hours after procedure), upon PACU discharge (~4 hours after procedure/medically cleared to leave PACU), on postoperative day 1, and postoperative day 7
Quality of Recovery on Postoperative Day 7 Measured by QoR-15 Survey	Quality of recovery measured using the Quality of Recover-15 (QoR-15) questionnaire on postoperative day 7. 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).	Postoperative day 7
Cardiologist Operating Conditions Rating	Cardiologist-rated procedural conditions assessed using a 5-point Likert scale. The cardiologist will report their satisfaction with the TAVR patient's surgical condition (5 = Very Satisfied; 1 = Very Dissatisfied)	Immediately after completion of the TAVR procedure (intraoperative period)
30-Day Readmission Rates	Hospital readmission rates within 30 days following TAVR	Within 30 days post-hospital discharge.
Incidence of Hypotension Requiring Medical Intervention	Incidence of hypotension (defined as ≥20% reduction from baseline) requiring medical intervention.	Intraoperative period
Fluid Administration From Start of Procedure Through PACU Discharge	Total intravenous fluid volume administered.	From procedure start through post-anesthesia care unit discharge (~4 hours after procedure/medically cleared to leave PACU)
Incidence of Intraoperative Bradycardia	Incidence of heart rate < 60 beats per minute.	Intraoperative period
Surgical Bleeding	Incidence of clinically significant surgical bleeding.	Intraoperative period
Conversion to General Anesthesia	Need for conversion from planned sedation to general anesthesia.	Intraoperative period
Postoperative Pacemaker Placement	Need for new permanent pacemaker implantation after TAVR.	During postoperative period (within 30 days)
Postoperative Delirium Measured by 4AT Assessment	Incidence of postoperative delirium assessed using the 4AT screening tool.	Preoperative baseline, upon PACU discharge (~4 hours after procedure/medically cleared to leave PACU), and 24 hours postoperatively

Collaborators and Investigators

• Sponsor: David Lyubashevsky

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: April 15, 2026
• First Submitted That Met QC Criteria: April 22, 2026
• First Posted (Actual): April 29, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Anesthesia; TAVR; Transcatheter aortic valve replacement; Sedation strategy
• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Azoles; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Imidazoles; Piperidines; Phenols; Benzene Derivatives; Benzazepines; Benzodiazepines; Midazolam; Dexmedetomidine; Propofol; Fentanyl
• Other Study ID Numbers: IRB2025-0154

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared due to institutional policies and to protect participant privacy.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No