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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
126
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 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 will be administered intravenously for intraoperative sedation during TAVR and titrated to achieve adequate sedation and analgesia according to standard anesthesia practice.
Fentanyl will be administered intravenously for intraoperative sedation during TAVR and titrated to achieve adequate sedation and analgesia according to standard anesthesia practice.
Endeavor Health
Glenview, Illinois, United States
RECRUITINGQuality 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
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
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)
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
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
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).
Time frame: 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)
Time frame: Immediately after completion of the TAVR procedure (intraoperative period)
30-Day Readmission Rates
Hospital readmission rates within 30 days following TAVR
Time frame: Within 30 days post-hospital discharge.
Incidence of Hypotension Requiring Medical Intervention
Incidence of hypotension (defined as ≥20% reduction from baseline) requiring medical intervention.
Time frame: Intraoperative period
Fluid Administration From Start of Procedure Through PACU Discharge
Total intravenous fluid volume administered.
Time frame: 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.
Time frame: Intraoperative period
Surgical Bleeding
Incidence of clinically significant surgical bleeding.
Time frame: Intraoperative period
Conversion to General Anesthesia
Need for conversion from planned sedation to general anesthesia.
Time frame: Intraoperative period
Postoperative Pacemaker Placement
Need for new permanent pacemaker implantation after TAVR.
Time frame: During postoperative period (within 30 days)
Postoperative Delirium Measured by 4AT Assessment
Incidence of postoperative delirium assessed using the 4AT screening tool.
Time frame: Preoperative baseline, upon PACU discharge (~4 hours after procedure/medically cleared to leave PACU), and 24 hours postoperatively
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