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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propofol | Experimental | Participants will receive propofol for intraoperative sedation during transcatheter aortic valve replacement (TAVR). |
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| Dexmedetomidine | Experimental | Participants will receive dexmedetomidine for intraoperative sedation during transcatheter aortic valve replacement (TAVR). |
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| Midazolam and Fentanyl | Experimental | Participants will receive a combination of midazolam and fentanyl for intraoperative sedation during transcatheter aortic valve replacement (TAVR). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | From baseline assessment prior to transcatheter aortic valve replacement (TAVR) through postoperative day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate Change | Change in heart rate from baseline to nadir intraoperatively and at Post-Anesthesia Care Unit (PACU) admission. | Intraoperative period through PACU admission |
| Length of Stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jessica Brickner | Contact | 847-570-1197 | jessica.brickner@endeavorhealth.org | |
| Nia Moragne | Contact | 847-570-1197 | nia.moragne@endeavorhealth.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Endeavor Health | Recruiting | Glenview | Illinois | 60026 | United States |
Individual participant data will not be shared due to institutional policies and to protect participant privacy.
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| D020927 | Dexmedetomidine |
| D008874 | Midazolam |
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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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.
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The clinical team, including the cardiologist, nurses, and other staff, will be blinded to the treatment.
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| 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. |
|
PACU length of stay and total hospital length of stay
| 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 | 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). | Postoperative day 1 and postoperative day 7 |
| Pain Scores Measured by Visual Analog Scale (VAS) | Pain severity measured using the 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 |
| 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). | Postoperative day 7 |
| 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) | Immediately after completion of the TAVR procedure (intraoperative period) |
| 30-Day Readmission Rates | Hospital readmission rates within 30 days following TAVR | Within 30 days post-hospital discharge. |
| Incidence of Hypotension Requiring Medical Intervention | Incidence of hypotension (defined as ≥20% reduction from baseline) requiring medical intervention. | Intraoperative period |
| Fluid Administration From Start of Procedure Through PACU Discharge | Total intravenous fluid volume administered. | From procedure start through post-anesthesia care unit discharge (~4 hours after procedure/medically cleared to leave PACU) |
| Incidence of Intraoperative Bradycardia | Incidence of heart rate < 60 beats per minute. | Intraoperative period |
| Surgical Bleeding | Incidence of clinically significant surgical bleeding. | Intraoperative period |
| Conversion to General Anesthesia | Need for conversion from planned sedation to general anesthesia. | Intraoperative period |
| Postoperative Pacemaker Placement | Need for new permanent pacemaker implantation after TAVR. | During postoperative period (within 30 days) |
| Postoperative Delirium Measured by 4AT Assessment | Incidence of postoperative delirium assessed using the 4AT screening tool. | Preoperative baseline, upon PACU discharge (~4 hours after procedure/medically cleared to leave PACU), and 24 hours postoperatively |
| D014694 |
| Ventricular Outflow Obstruction |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010880 | Piperidines |