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Completed

NCT Number: NCT02786264

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

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).

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Dexmedetomidine with propofol

Drug

A dexmedetomidine- dominant anesthetic will be defined as an anesthetic that included a continuous infusion of dexmedetomidine within 15 minutes of anesthesia start. This group was subsequently modified in light of retrospective data collection to specify a group receiving dexmedetomidine in combination with propofol.

Other names: Precedex

Propofol

Drug

A propofol-dominant anesthetic will be defined as an anesthetic that included a continuous infusion of propofol within 15 minutes of anesthesia start. This definition was subsequently modified to include patients who received propofol infusion but not dexmedetomidine.

Other names: Diprivan

Primary outcomes

  1. Procedure Length

    Time frame: During surgery

    Procedure length will be collected from retrospective analysis of charts.

Secondary outcomes

  1. 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.

  2. Rate of Conversion to General Anesthesia

    Time frame: During surgery

    Rate of conversion to general anesthesia will be collected from retrospective analysis of charts.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

Pilot Analysis of the Association Between Types of Anesthetic and Outcomes in Transfemoral Aortic Valve Replacement

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 30, 2016
Registry last updated
Apr 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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