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Patient Quality of Recovery After TAVR With Different Sedation Regimens

ConditionsTranscatheter Aortic Valve Replacement (TAVR)Aortic Valve Stenosis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-90
SponsorDavid Lyubashevsky

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18-90 years old, inclusive

Undergoing transfemoral TAVR under Monitored Anesthesia Care (MAC)

Speaks English or Spanish

Consents to participate

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

126 Participants
are divided into 3 treatment groups
Group A: PropofolExperimental treatment 1 intervention
Group B: DexmedetomidineExperimental treatment 1 intervention
Group C: Midazolam and FentanylExperimental treatment 2 interventions

Trial outcomes

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).

Time frame
From baseline assessment prior to transcatheter aortic valve replacement (TAVR) through postoperative day 1

Secondary outcomes

1

Heart Rate Change

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

Time frame
Intraoperative period through PACU admission
2

Length of Stay

PACU length of stay and total hospital length of stay

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

Time frame
Postoperative day 1 and postoperative day 7
4

Pain Scores Measured by Visual Analog Scale (VAS)

Pain severity measured using the 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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

David Lyubashevsky

Lead sponsor

Endeavor Health

Sponsor institution

Source ClinicalTrials.gov
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