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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02786264
Recruitment Status : Active, not recruiting
First Posted : May 30, 2016
Last Update Posted : October 26, 2016
Sponsor:
Information provided by (Responsible Party):
Yale University

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).

Condition or disease Intervention/treatment
Aortic Stenosis Drug: Dexmedetomidine Drug: Propofol Drug: Fentanyl and/or Midazolam

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.

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Study Type : Observational
Actual Enrollment : 186 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Pilot Analysis of the Association Between Types of Anesthetic and Outcomes in Transfemoral Aortic Valve Replacement
Study Start Date : May 2016
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : May 2021


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.
Other Name: Diprivan

Dexmedetomidine-dominant Sedation
Patients receiving dexmedetomidine infusion for TAVR as the primary drug for sedation.
Drug: Dexmedetomidine
A dexmedetomidine- dominant anesthetic will be defined as an anesthetic that included a continuous infusion of dexmedetomidine within 15 minutes of anesthesia start.
Other Name: Precedex

Fentanyl and/or Midazolam Sedation
Patients receiving fentanyl +/- midazolam as the primary drugs for sedation for TAVR
Drug: Fentanyl and/or Midazolam
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.
Other Names:
  • Sublimaze
  • Versed




Primary Outcome Measures :
  1. Procedure length [ Time Frame: During surgery ]
    Procedure length will be collected from retrospective analysis of charts.


Secondary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02786264


Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Robert Schonberger, MD Yale University
Study Data/Documents: Statistical Analysis Plan  This link exits the ClinicalTrials.gov site

Publications:
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02786264    
Other Study ID Numbers: 1604017590
First Posted: May 30, 2016    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Yale University:
transcatheter aortic valve replacement
anesthesia
conscious sedation
managed anesthesia care
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Fentanyl
Midazolam
Dexmedetomidine
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents