Pragmatic Clinical Trial of Race-Specific Response to Propofol Infusion Titrated to Effect for Procedural Sedation During Endoscopy
| Registry | NCT03290859 |
|---|---|
| Status | Completed |
| Study type | Observational |
| Enrollment | 2780 (Actual) |
| Sponsor | University of Florida (Other); collaborators: National Center for Advancing Translational Sciences (NCATS) |
| Conditions | Unconsciousness, Apnea, Postanesthetic, Sedative Overdose, Hypoxemia |
| Interventions | Titrate propofol monotherapy infusion to effect (Procedure) |
| Dates | start 2018-01-05, primary completion 2019-02-05, completion 2019-02-05, first posted 2017-09-25, last updated 2019-10-25 |
| Locations | 1 site in United States |
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Prospectively evaluate newly established guidelines and make clinicians aware of inter-racial difference in propofol sensitivity.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Training intervention | Procedure: 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. | |
| Effectiveness of training intervention | Compare the effectiveness of training intervention and standardized titration to effect through aggregate data for metrics of recovery times. |
Sex: All, ages: 18 Years to 80 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| UF Health | Gainesville, Florida | United States |
NIH grants: UL1TR001427