Association of Type of Anesthetic and Outcomes in Transfemoral Aortic Valve Replacement
|ClinicalTrials.gov Identifier: NCT02786264|
Recruitment Status : Active, not recruiting
First Posted : May 30, 2016
Last Update Posted : October 26, 2016
|Condition or disease||Intervention/treatment|
|Aortic Stenosis||Drug: Dexmedetomidine Drug: Propofol Drug: Fentanyl and/or Midazolam|
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.
|Study Type :||Observational|
|Actual Enrollment :||186 participants|
|Official Title:||Pilot Analysis of the Association Between Types of Anesthetic and Outcomes in Transfemoral Aortic Valve Replacement|
|Study Start Date :||May 2016|
|Estimated Primary Completion Date :||September 2017|
|Estimated Study Completion Date :||May 2021|
Patients receiving propofol infusion for TAVR as the primary drug for sedation.
A propofol-dominant anesthetic will be defined as an anesthetic that included a continuous infusion of propofol within 15 minutes of anesthesia start.
Other Name: Diprivan
Patients receiving dexmedetomidine infusion for TAVR as the primary drug for sedation.
A dexmedetomidine- dominant anesthetic will be defined as an anesthetic that included a continuous infusion of dexmedetomidine within 15 minutes of anesthesia start.
Other Name: Precedex
Fentanyl and/or Midazolam Sedation
Patients receiving fentanyl +/- midazolam as the primary drugs for sedation for TAVR
Drug: Fentanyl and/or Midazolam
A fentanyl / midazolam dominant anesthetic will be defined as monitored anesthesia care in the presence of fentanyl or midazolam and in the absence of a propofol or dexmedetomidine infusion.
- Procedure length [ Time Frame: During surgery ]Procedure length will be collected from retrospective analysis of charts.
- ICU length of stay [ Time Frame: 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.
- Rate of conversion to general anesthesia [ Time Frame: During surgery ]Rate of conversion to general anesthesia will be collected from retrospective analysis of charts.
- Hospital length of stay [ Time Frame: 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.
- Delirium incidence [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02786264
|Principal Investigator:||Robert Schonberger, MD||Yale University|