Patient Quality of Recovery After TAVR With Different Sedation Regimens

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified March 2026 by David Lyubashevsky
Sponsor
David Lyubashevsky
Information Provided by (Responsible Party)
David Lyubashevsky
Clinicaltrials.gov Identifier
NCT07556523
Other Study ID Numbers:
IRB2025-0154
First Submitted
April 14, 2026
First Posted
April 28, 2026
Last Update Posted
April 28, 2026
Last Verified
March 2026

ClinicalTrials.gov processed this data on April 2026Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Transcatheter Aortic Valve Replacement (TAVR)Aortic Valve Stenosis
Drug: PropofolDrug: DexmedetomidineDrug: Midazolam

Study Design

Study TypeInterventional
Actual Enrollment126 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingDouble
Primary PurposeTreatment
Official TitlePatient Quality of Recovery After TAVR With Different Sedation Regimens
Study Start DateMarch 15, 2026
Actual Primary Completion Date1yr 8mos from now
Actual Study Completion Date1yr 10mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
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.
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.
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.

Outcome Measures

Primary Outcome Measures
  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).
Secondary Outcome Measures
  1. Heart Rate Change
    Change in heart rate from baseline to nadir intraoperatively and at Post-Anesthesia Care Unit (PACU) admission.
  2. Length of Stay
    PACU length of stay and total hospital length of stay
  3. 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).
  4. Pain Scores Measured by Visual Analog Scale (VAS)
    Pain severity measured using the Visual Analog Scale (VAS).
  5. 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).
  6. 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)
  7. 30-Day Readmission Rates
    Hospital readmission rates within 30 days following TAVR
  8. Incidence of Hypotension Requiring Medical Intervention
    Incidence of hypotension (defined as ≥20% reduction from baseline) requiring medical intervention.
  9. Fluid Administration From Start of Procedure Through PACU Discharge
    Total intravenous fluid volume administered.
  10. Incidence of Intraoperative Bradycardia
    Incidence of heart rate \< 60 beats per minute.
  11. Surgical Bleeding
    Incidence of clinically significant surgical bleeding.
  12. Conversion to General Anesthesia
    Need for conversion from planned sedation to general anesthesia.
  13. Postoperative Pacemaker Placement
    Need for new permanent pacemaker implantation after TAVR.
  14. Postoperative Delirium Measured by 4AT Assessment
    Incidence of postoperative delirium assessed using the 4AT screening tool.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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

Contacts and Locations

Sponsors and CollaboratorsDavid Lyubashevsky
Locations
Endeavor Health | Glenview Illinois, United States, 60026