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Race-Specific Propofol Titration to Effect for Procedural Sedation

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03290859
Enrollment
2780
Registered
2017-09-25
Start date
2018-01-05
Completion date
2019-02-05
Last updated
2019-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apnea, Postanesthetic, Hypoxemia, Sedative Overdose, Unconsciousness

Keywords

Procedural Sedation

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.

Interventions

PROCEDURETitrate propofol monotherapy infusion to effect

Train anesthesia providers in a standardized protocol for titrating propofol infusion to effect.

Sponsors

National Center for Advancing Translational Sciences (NCATS)
CollaboratorNIH
University of Florida
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in the recovery times among races and ethnicitiesChange from baseline up to 24 hoursMonitored using aggregate data for metrics of recovery times

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026