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

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

Study Overview

• Status: Completed
• Conditions: Unconsciousness; Hypoxemia; Apnea, Postanesthetic; Sedative Overdose
• Intervention / Treatment: Procedure: Titrate propofol monotherapy infusion to effect

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 Type: Observational
• Enrollment (Actual): 2780

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • UF Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Train anesthesia providers in a standardized protocol for titrating propofol 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the recovery times among races and ethnicities	Monitored using aggregate data for metrics of recovery times	Change from baseline up to 24 hours

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: National Center for Advancing Translational Sciences (NCATS)
• Investigators: Principal Investigator: Jeffrey White, MD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2018
• Primary Completion (Actual): February 5, 2019
• Study Completion (Actual): February 5, 2019

Study Registration Dates

• First Submitted: September 18, 2017
• First Submitted That Met QC Criteria: September 20, 2017
• First Posted (Actual): September 25, 2017

Study Record Updates

• Last Update Posted (Actual): October 25, 2019
• Last Update Submitted That Met QC Criteria: October 23, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Procedural Sedation
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Signs and Symptoms, Respiratory; Consciousness Disorders; Hypoxia; Unconsciousness; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: IRB201701064 - N; UL1TR001427 (U.S. NIH Grant/Contract); OCR18882 (Other Identifier: University of Florida)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No