Overview

This trial is active, not recruiting.

Condition aortic stenosis
Treatments dexmedetomidine, propofol, fentanyl and/or midazolam
Sponsor Yale University
Start date May 2016
End date September 2017
Trial size 186 participants
Trial identifier NCT02786264, 1604017590

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm
Patients receiving propofol infusion for TAVR as the primary drug for sedation.
propofol Diprivan
A propofol-dominant anesthetic will be defined as an anesthetic that included a continuous infusion of propofol within 15 minutes of anesthesia start.
Patients receiving dexmedetomidine infusion for TAVR as the primary drug for sedation.
dexmedetomidine Precedex
A dexmedetomidine- dominant anesthetic will be defined as an anesthetic that included a continuous infusion of dexmedetomidine within 15 minutes of anesthesia start.
Patients receiving fentanyl +/- midazolam as the primary drugs for sedation for TAVR
fentanyl and/or midazolam Sublimaze
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.

Primary Outcomes

Measure
Procedure length
time frame: During surgery

Secondary Outcomes

Measure
ICU length of stay
time frame: From the conclusion of surgery until patient leaves the ICU, up to 2 weeks
Rate of conversion to general anesthesia
time frame: During surgery
Hospital length of stay
time frame: From the conclusion of surgery until patient is discharged, up to 2 weeks
Delirium incidence
time frame: From the conclusion of surgery until patient is discharged, up to 2 weeks

Eligibility Criteria

Male or female participants of any age.

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).

Additional Information

Official title Pilot Analysis of the Association Between Types of Anesthetic and Outcomes in Transfemoral Aortic Valve Replacement
Principal investigator Robert Schonberger, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Yale University.