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Recruiting NCT07556523

Patient Quality of Recovery After TAVR With Different Sedation Regimens

Phase IV Interventional Transcatheter Aortic Valve Replacement (TAVR) Aortic Valve Stenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Propofol, Dexmedetomidine, Midazolam, Fentanyl.
Who it may be relevant to
Registry conditions: Transcatheter Aortic Valve Replacement (TAVR), Aortic Valve Stenosis. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

  • 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.
  • 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.
  • 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.

Primary outcome measures

  • 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]
Secondary outcome measures (12)
  • Heart Rate Change [Time frame: Intraoperative period through PACU admission]
  • Length of Stay [Time frame: 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 [Time frame: Postoperative day 1 and postoperative day 7]
  • 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]
  • Quality of Recovery on Postoperative Day 7 Measured by QoR-15 Survey [Time frame: Postoperative day 7]
  • Cardiologist Operating Conditions Rating [Time frame: Immediately after completion of the TAVR procedure (intraoperative period)]
  • 30-Day Readmission Rates [Time frame: Within 30 days post-hospital discharge.]
  • Incidence of Hypotension Requiring Medical Intervention [Time frame: Intraoperative period]
  • 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)]
  • Incidence of Intraoperative Bradycardia [Time frame: Intraoperative period]
  • Surgical Bleeding [Time frame: Intraoperative period]
  • Conversion to General Anesthesia [Time frame: Intraoperative period]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Endeavor Health — Glenview

Identifiers

NCT: NCT07556523 · IRB2025-0154

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗