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Clinical Trials/NCT03290859
NCT03290859
Completed
Not Applicable

Pragmatic Clinical Trial of Race-Specific Response to Propofol Infusion Titrated to Effect for Procedural Sedation During Endoscopy

University of Florida1 site in 1 country2,780 target enrollmentJanuary 5, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Unconsciousness
Sponsor
University of Florida
Enrollment
2780
Locations
1
Primary Endpoint
Change in the recovery times among races and ethnicities
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Prospectively evaluate newly established guidelines and make clinicians aware of inter-racial difference in propofol sensitivity.

Detailed Description

The primary motivation in conducting this study is to conduct the implementation science, i.e., formalize and train, and retrain if needed, anesthesia providers in the standard practice of titrating infusion rate to effect and clinically evaluate the effect of race and ethnicity on propofol monotherapy sedation during GI endoscopy. The ultimate goal is to make it less likely that patients from races known to be sensitive to propofol experience inadvertent overdosing.

Registry
clinicaltrials.gov
Start Date
January 5, 2018
End Date
February 5, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients undergoing propofol sedation at Gainesville (GNV) and Jacksonville (JAX) GI Endoscopy suites
  • Age range 18 - 80 years old
  • Patients whose race can be identified from the electronic patient information chart (EPIC)

Exclusion Criteria

  • Patients who identify as multiracial in Epic
  • Patients who identify as Other in Epic
  • Patients who refuse to indicate their race in Epic
  • Patients whose race is listed as unknown in Epic

Outcomes

Primary Outcomes

Change in the recovery times among races and ethnicities

Time Frame: Change from baseline up to 24 hours

Monitored using aggregate data for metrics of recovery times

Study Sites (1)

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