Race-Specific Propofol Titration to Effect for Procedural Sedation

Completed

• Conditions: Unconsciousness; Sedative Overdose; Hypoxemia; Apnea, Postanesthetic
• Interventions: Procedure: Titrate propofol monotherapy infusion to effect

• Registration Number: NCT03290859
• Lead Sponsor: University of Florida

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.

Study Timeline

• Study First Submitted: 2017-09-18
• Study First Submitted QC: 2017-09-20
• Study First Posted: 2017-09-25
• Study Start: 2018-01-05
• Primary Completion: 2019-02-05
• Study Completion: 2019-02-05
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-23
• Last Update Posted: 2019-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2780

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)

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Training intervention	Titrate propofol monotherapy infusion to effect	Train anesthesia providers who deliver propofol sedation for GI endoscopy procedures to follow a uniform propofol monotherapy administration guideline to titrate propofol monotherapy infusion to effect according to a standardized protocol.

Primary Outcome Measures

Name	Time	Method
Change in the recovery times among races and ethnicities	Change from baseline up to 24 hours	Monitored using aggregate data for metrics of recovery times

Trial Locations

Locations (1)

UF Health; 🇺🇸 Gainesville, Florida, United States