Race-Specific Propofol Titration to Effect for Procedural Sedation

NCT03290859 | Completed DMC

• 3 other identifiers: IRB201701064 - NUL1TR001427OCR18882
• Study Type: observational
• Target: 2,780
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Unconsciousness; Apnea, Postanesthetic; Sedative Overdose; Hypoxemia

Keywords

Procedural Sedation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Titrate propofol monotherapy infusion to effect PROCEDURE

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

Training intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

UF Health

Gainesville, Florida, 32610, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Compare in buccal samples the frequency of cytochrome allele carrier status in patients exhibiting sensitivity to propofol during the procedural time against published frequency data in Single Nucleotide Polymorphism database (dbSNP) by race.

MeSH Terms

Conditions

Unconsciousness; Butyrylcholinesterase deficiency; Hypoxia

Condition Hierarchy (Ancestors)

Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory

Study Officials

• Jeffrey White, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2017
• First Posted: September 25, 2017
• Study Start: January 5, 2018
• Primary Completion: February 5, 2019
• Study Completion: February 5, 2019
• Last Updated: October 25, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)