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NCT Number: NCT07556523

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

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Key information

Conditions

Transcatheter Aortic Valve Replacement (TAVR) Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Endeavor Health

Glenview, Illinois, 60026, United States

Location status: Recruiting

Location contact

David Lyubashevsky, MD

PRINCIPAL_INVESTIGATOR

Jessica Brickner

CONTACT

[email protected]

847-570-1197

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Heart Rate Change

    Time frame: Intraoperative period through PACU admission

    Change in heart rate from baseline to nadir intraoperatively and at Post-Anesthesia Care Unit (PACU) admission.

  2. Length of Stay

    Time frame: From date of procedure through hospital discharge (up to 30 days after procedure date, whichever comes first)

    PACU length of stay and total hospital length of stay

  3. Patient Satisfaction with Anesthesia Measured by 5-Point Likert Scale

    Time frame: Postoperative day 1 and postoperative day 7

    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).

  4. Pain Scores Measured by Visual Analog Scale (VAS)

    Time frame: 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

    Pain severity measured using the Visual Analog Scale (VAS).

  5. Quality of Recovery on Postoperative Day 7 Measured by QoR-15 Survey

    Time frame: Postoperative day 7

    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).

  6. Cardiologist Operating Conditions Rating

    Time frame: Immediately after completion of the TAVR procedure (intraoperative period)

    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)

  7. 30-Day Readmission Rates

    Time frame: Within 30 days post-hospital discharge.

    Hospital readmission rates within 30 days following TAVR

  8. Incidence of Hypotension Requiring Medical Intervention

    Time frame: Intraoperative period

    Incidence of hypotension (defined as ≥20% reduction from baseline) requiring medical intervention.

  9. Fluid Administration From Start of Procedure Through PACU Discharge

    Time frame: From procedure start through post-anesthesia care unit discharge (~4 hours after procedure/medically cleared to leave PACU)

    Total intravenous fluid volume administered.

  10. Incidence of Intraoperative Bradycardia

    Time frame: Intraoperative period

    Incidence of heart rate < 60 beats per minute.

  11. Surgical Bleeding

    Time frame: Intraoperative period

    Incidence of clinically significant surgical bleeding.

  12. Conversion to General Anesthesia

    Time frame: Intraoperative period

    Need for conversion from planned sedation to general anesthesia.

  13. Postoperative Pacemaker Placement

    Time frame: During postoperative period (within 30 days)

    Need for new permanent pacemaker implantation after TAVR.

  14. Postoperative Delirium Measured by 4AT Assessment

    Time frame: Preoperative baseline, upon PACU discharge (~4 hours after procedure/medically cleared to leave PACU), and 24 hours postoperatively

    Incidence of postoperative delirium assessed using the 4AT screening tool.

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica Brickner

CONTACT

[email protected]

847-570-1197

Nia Moragne

CONTACT

[email protected]

847-570-1197

Sponsors and collaborators

Lead sponsor

David Lyubashevsky

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 29, 2026
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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