Brief Title
Association of Type of Anesthetic and Outcomes in Transfemoral Aortic Valve Replacement
Official Title
Pilot Analysis of the Association Between Types of Anesthetic and Outcomes in Transfemoral Aortic Valve Replacement
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.
Study Type
Observational
Primary Outcome
Procedure length
Secondary Outcome
ICU length of stay
Condition
Aortic Stenosis
Intervention
Dexmedetomidine
Study Arms / Comparison Groups
Propofol-dominant Sedation
Description: Patients receiving propofol infusion for TAVR as the primary drug for sedation.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
186
Start Date
May 2016
Completion Date
May 2021
Primary Completion Date
September 2017
Eligibility Criteria
Inclusion Criteria: - Patients who underwent TAVR at YNHH under planned conscious sedation with monitored anesthetic care Exclusion Criteria: - Patients who received monitored anesthesia care without the receipt of any study intervention drug (propofol, fentanyl, midazolam, or dexmedetomidine).
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Robert Schonberger, MD, ,
Administrative Informations
NCT ID
NCT02786264
Organization ID
1604017590
Responsible Party
Sponsor
Study Sponsor
Yale University
Study Sponsor
Robert Schonberger, MD, Principal Investigator, Yale University
Verification Date
October 2016