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Association of Type of Anesthetic and Outcomes in Transfemoral Aortic Valve Replacement

Yale University logo

Yale University

Status

Completed

Conditions

Aortic Stenosis

Treatments

Drug: Propofol
Drug: Dexmedetomidine with propofol

Study type

Observational

Funder types

Other

Identifiers

NCT02786264
1604017590

Details and patient eligibility

About

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).

Full 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.

Enrollment

186 patients

Sex

All

Volunteers

No Healthy Volunteers

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).

Trial design

186 participants in 2 patient groups

Propofol-dominant Sedation
Description:
Patients receiving propofol infusion for TAVR as the primary drug for sedation.
Treatment:
Drug: Propofol
Dexmedetomidine-dominant Sedation
Description:
Patients receiving dexmedetomidine infusion for TAVR as the primary drug for sedation.
Treatment:
Drug: Propofol
Drug: Dexmedetomidine with propofol

Trial documents
2

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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