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CompletedNCT03290859Updated Oct 25, 2019

Race-Specific Propofol Titration to Effect for Procedural Sedation

An observational study in Unconsciousness, Apnea, Postanesthetic and Sedative Overdose, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-10-25.

Sponsored by University of Florida · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
2,780
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Unconsciousness
  • Apnea, Postanesthetic
  • Sedative Overdose
  • Hypoxemia

Keywords

  • Procedural Sedation
03

In context

Unconsciousness

60 studies on the registry are indexed under Unconsciousness; 9 are open to participants now.

This study's enrollment of 2,780 is above the median of 200 across 21 observational studies indexed under Unconsciousness.

Browse Unconsciousness studies →

Lead sponsor

University of Florida is the lead sponsor of 1,287 studies on the registry; 199 are open to participants now.

Of its 180 completed or terminated interventional studies of FDA-regulated products, 143 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients undergoing propofol sedation at Gainesville (GNV) and Jacksonville (JAX) GI Endoscopy suites

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
2,780 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Training intervention

    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.

    Procedure: Titrate propofol monotherapy infusion to effect

  • Effectiveness of training intervention

    Compare the effectiveness of training intervention and standardized titration to effect through aggregate data for metrics of recovery times.

Interventions

  • ProcedureTitrate propofol monotherapy infusion to effect

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

06

What researchers measure

Primary outcomes

  1. Change in the recovery times among races and ethnicities

    Monitored using aggregate data for metrics of recovery times

    Time frame: Change from baseline up to 24 hours

07

Study locations

1 site
  • UF Health
    Gainesville, Florida 32610, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2018 to primary completion in Feb 2019, 13 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 18, 2017
First posted
Sep 25, 2017
StartActual
Jan 5, 2018
Primary completionActual
Feb 5, 2019
CompletionActual
Feb 5, 2019
Last update
Oct 25, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03290859
Responsible party
Sponsor
First posted
Sep 25, 2017
Start date
Jan 5, 2018
Primary completion
Feb 5, 2019
Completion
Feb 5, 2019
Last update
Oct 25, 2019

Study contacts

Jeffrey White, MD
principal investigator · University of Florida

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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