Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement (TAVR)
Conditions
Keywords
Transcatheter aortic valve replacement, TAVR, Sedation strategy, Anesthesia
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
Interventions
DRUGPropofol
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.
DRUGDexmedetomidine
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.
DRUGMidazolam
Midazolam will be administered intravenously for intraoperative sedation during TAVR and titrated to achieve adequate sedation and analgesia according to standard anesthesia practice.
DRUGFentanyl
Fentanyl will be administered intravenously for intraoperative sedation during TAVR and titrated to achieve adequate sedation and analgesia according to standard anesthesia practice.
Sponsors
David Lyubashevsky
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
The clinical team, including the cardiologist, nurses, and other staff, will be blinded to the treatment.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Recovery on Postoperative Day 1 Measured by QoR-15 Survey | 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
| Measure | Time frame | Description |
|---|---|---|
| Heart Rate Change | Intraoperative period through PACU admission | Change in heart rate from baseline to nadir intraoperatively and at Post-Anesthesia Care Unit (PACU) admission. |
| Length of Stay | 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 |
| Patient Satisfaction with Anesthesia Measured by 5-Point Likert Scale | 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). |
| 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 | Pain severity measured using the Visual Analog Scale (VAS). |
| Quality of Recovery on Postoperative Day 7 Measured by QoR-15 Survey | 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). |
| Cardiologist Operating Conditions Rating | 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) |
| 30-Day Readmission Rates | Within 30 days post-hospital discharge. | Hospital readmission rates within 30 days following TAVR |
| Incidence of Hypotension Requiring Medical Intervention | Intraoperative period | Incidence of hypotension (defined as ≥20% reduction from baseline) requiring medical intervention. |
| Fluid Administration From Start of Procedure Through PACU Discharge | From procedure start through post-anesthesia care unit discharge (~4 hours after procedure/medically cleared to leave PACU) | Total intravenous fluid volume administered. |
| Incidence of Intraoperative Bradycardia | Intraoperative period | Incidence of heart rate \< 60 beats per minute. |
| Surgical Bleeding | Intraoperative period | Incidence of clinically significant surgical bleeding. |
| Conversion to General Anesthesia | Intraoperative period | Need for conversion from planned sedation to general anesthesia. |
| Postoperative Pacemaker Placement | During postoperative period (within 30 days) | Need for new permanent pacemaker implantation after TAVR. |
| Postoperative Delirium Measured by 4AT Assessment | 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. |
Countries
United States
Contacts
CONTACTJessica Brickner
CONTACTNia Moragne
Outcome results
None listed