Patient Quality of Recovery After TAVR With Different Sedation Regimens

NCT07556523 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: IRB2025-0154
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

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

Aortic Valve Stenosis; Transcatheter Aortic Valve Replacement (TAVR)

Keywords

Transcatheter aortic valve replacement; TAVR; Sedation strategy; Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Heart Rate Change

  Intraoperative period through PACU admission

• 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

  Postoperative day 1 and postoperative day 7

• Pain Scores Measured by 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

  Postoperative day 7

Study Arms (3)

Propofol

EXPERIMENTAL

Participants will receive propofol for intraoperative sedation during transcatheter aortic valve replacement (TAVR).

Drug: Propofol

Dexmedetomidine

EXPERIMENTAL

Participants will receive dexmedetomidine for intraoperative sedation during transcatheter aortic valve replacement (TAVR).

Drug: Dexmedetomidine

Midazolam and Fentanyl

EXPERIMENTAL

Participants will receive a combination of midazolam and fentanyl for intraoperative sedation during transcatheter aortic valve replacement (TAVR).

Drug: Midazolam; Drug: Fentanyl

Interventions

Propofol DRUG

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.

Propofol

Dexmedetomidine DRUG

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.

Dexmedetomidine

Midazolam DRUG

Midazolam will be administered intravenously for intraoperative sedation during TAVR and titrated to achieve adequate sedation and analgesia according to standard anesthesia practice.

Midazolam and Fentanyl

Fentanyl DRUG

Fentanyl will be administered intravenously for intraoperative sedation during TAVR and titrated to achieve adequate sedation and analgesia according to standard anesthesia practice.

Midazolam and Fentanyl

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• David Lyubashevsky: lead

Study Sites (1)

Endeavor Health

Glenview, Illinois, 60026, United States

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Propofol; Dexmedetomidine; Midazolam; Fentanyl

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Piperidines

Central Study Contacts

Jessica Brickner

CONTACT

847-570-1197; jessica.brickner@endeavorhealth.org

Nia Moragne

CONTACT

847-570-1197; nia.moragne@endeavorhealth.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The clinical team, including the cardiologist, nurses, and other staff, will be blinded to the treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Anesthesiologist

Model Details: 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.

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 29, 2026
• Study Start: March 16, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)