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

NCT ID: NCT02786264

Last Updated: 2023-04-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 186 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2017-05-31

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).

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.

Conditions

Aortic Stenosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Propofol-dominant Sedation

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

Propofol

Intervention Type: 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.

Dexmedetomidine-dominant Sedation

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

Dexmedetomidine with propofol

Intervention Type: 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.

Propofol

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Precedex; Diprivan

Eligibility 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).

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Schonberger, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

References

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.

Reference Type: BACKGROUND

PMID: 24612945 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Study Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

1604017590

Identifier Type: -

Identifier Source: org_study_id