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

August 4, 2022 updated by: Yale University

Pilot Analysis of the Association Between Types 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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

186

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who underwent TAVR under a plan for conscious sedation with monitored anesthetic care rather than general anesthesia.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedure Length
Time Frame: During surgery
Procedure length will be collected from retrospective analysis of charts.
During surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the conclusion of surgery until patient leaves the ICU, up to 2 weeks
Rate of Conversion to General Anesthesia
Time Frame: During surgery
Rate of conversion to general anesthesia will be collected from retrospective analysis of charts.
During surgery
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.
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
Whether or not the patient experiences delirium during their hospital stay as recorded in their notes by the treating physician.
From the conclusion of surgery until patient is discharged, up to 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Investigators

  • Principal Investigator: Robert Schonberger, MD, Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

May 11, 2016

First Submitted That Met QC Criteria

May 25, 2016

First Posted (Estimate)

May 30, 2016

Study Record Updates

Last Update Posted (Actual)

April 24, 2023

Last Update Submitted That Met QC Criteria

August 4, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1604017590

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Study Data/Documents

  1. Statistical Analysis Plan

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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