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

NCT02786264 | Completed Results

• 1 other identifier: 1604017590
• Study Type: observational
• Target: 186
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Aortic Stenosis

Keywords

transcatheter aortic valve replacement; anesthesia; conscious sedation; managed anesthesia care

Outcome Measures

Primary Outcomes (1)

• Procedure Length

  Procedure length will be collected from retrospective analysis of charts.

  During surgery

Secondary Outcomes (4)

• ICU Length of Stay

  From the conclusion of surgery until patient leaves the ICU, up to 2 weeks

• Rate of Conversion to General Anesthesia

  During surgery

• Hospital Length of Stay

  From the conclusion of surgery until patient is discharged, up to 2 weeks

• Delirium Incidence

  From the conclusion of surgery until patient is discharged, up to 2 weeks

Study Arms (2)

Propofol-dominant Sedation

Patients receiving propofol infusion for TAVR as the primary drug for sedation.

Drug: Propofol

Dexmedetomidine-dominant Sedation

Patients receiving dexmedetomidine infusion for TAVR as the primary drug for sedation.

Drug: Dexmedetomidine with propofol; Drug: Propofol

Interventions

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.

Also known as: Precedex

Dexmedetomidine-dominant Sedation

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.

Also known as: Diprivan

Dexmedetomidine-dominant Sedation; Propofol-dominant Sedation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients who underwent TAVR at YNHH under planned conscious sedation with monitored anesthetic care

You may not qualify if:

• Patients who received monitored anesthesia care without the receipt of any study intervention drug (propofol, fentanyl, midazolam, or dexmedetomidine).

Sponsors & Collaborators

• Yale University: lead

Related Publications (1)

• Frohlich GM, Lansky AJ, Webb J, Roffi M, Toggweiler S, Reinthaler M, Wang D, Hutchinson N, Wendler O, Hildick-Smith D, Meier P. Local versus general anesthesia for transcatheter aortic valve implantation (TAVR)--systematic review and meta-analysis. BMC Med. 2014 Mar 10;12:41. doi: 10.1186/1741-7015-12-41.

  PMID: 24612945 BACKGROUND

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Dexmedetomidine; Propofol

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Dr. Robert Schonberger
• Organization: Yale School of Medicine

robert.schonberger@yale.edu

2037852802

Study Officials

• Robert Schonberger, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2016
• First Posted: May 30, 2016
• Study Start: May 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: April 24, 2023
• Results First Posted: April 24, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share