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OpenTrials
Completed

NCT Number: NCT03290859

Race-Specific Propofol Titration to Effect for Procedural Sedation

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

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Key information

Conditions

Unconsciousness Apnea, Postanesthetic Butyrylcholinesterase deficiency Consciousness Disorders Hypoxemia Hypoxia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sedative Overdose Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UF Health

Gainesville, Florida, 32610, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Titrate propofol monotherapy infusion to effect

Procedure

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 25, 2017
Registry last updated
Oct 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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