Association of Type of Anesthetic and Outcomes in Transfemoral Aortic Valve Replacement
- Registration Number
- NCT02786264
- Lead Sponsor
- Yale University
- Brief Summary
This study proposes to perform a descriptive analysis and pilot observational study looking at the types and quantity of anesthetic agents used and their associations with outcomes among patients scheduled to receive transfemoral aortic valve replacements (TAVR) at Yale New Haven Hospital (YNHH).
- Detailed Description
This study proposes to perform a descriptive analysis and pilot observational study looking at the types and quantity of anesthetic agents used and their associations with outcomes among patients scheduled to receive TAVR at YNHH.
Hypothesis 1: TAVR surgery done under monitored anesthesia care are performed using some combination of the following anesthetics: dexmedetomidine, propofol, fentanyl, and midazolam.
Hypothesis 2: Age-adjusted dosing of these agents will be insufficient to account for extreme age after controlling for preoperative comorbid status.
Hypothesis 3: The rate of conversion to general anesthesia will be unrelated to the type of conscious sedation used.
Hypothesis 4: ICU length of stay, delirium, hospital length of stay, and length of hospital stay will be shorter for patients who were sedated using dexmedetomidine vs those without.
Research Plan: The research will be done via chart review and analysis of data already contained in the Multicenter Perioperative Outcomes Group databases at Yale. The possible risks are primarily the risk to privacy that is inherent in any retrospective chart review. The benefit may be to suggest areas of future study to improve sedation practices for TAVR at Yale and elsewhere. Information recorded will include demographic and preoperative medical assessment from prior to the TAVR, the anesthetic record, and the post-operative course of recovery for patients undergoing TAVR. These data will include age, gender, comorbidities, laboratory values, vital signs, and the results of imaging studies as well as other records potentially related to the above hospitalization.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 186
- Patients who underwent TAVR at YNHH under planned conscious sedation with monitored anesthetic care
- Patients who received monitored anesthesia care without the receipt of any study intervention drug (propofol, fentanyl, midazolam, or dexmedetomidine).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Dexmedetomidine-dominant Sedation Dexmedetomidine with propofol Patients receiving dexmedetomidine infusion for TAVR as the primary drug for sedation. Propofol-dominant Sedation Propofol Patients receiving propofol infusion for TAVR as the primary drug for sedation. Dexmedetomidine-dominant Sedation Propofol Patients receiving dexmedetomidine infusion for TAVR as the primary drug for sedation.
- Primary Outcome Measures
Name Time Method Procedure Length During surgery Procedure length will be collected from retrospective analysis of charts.
- Secondary Outcome Measures
Name Time Method Hospital Length of Stay From the conclusion of surgery until patient is discharged, up to 2 weeks Hospital length of stay will be collected via retrospective analysis of charts.
ICU Length of Stay From the conclusion of surgery until patient leaves the ICU, up to 2 weeks ICU length of stay will be collected from retrospective analysis of charts.
Delirium Incidence From the conclusion of surgery until patient is discharged, up to 2 weeks Whether or not the patient experiences delirium during their hospital stay as recorded in their notes by the treating physician.
Rate of Conversion to General Anesthesia During surgery Rate of conversion to general anesthesia will be collected from retrospective analysis of charts.