Race-Specific Propofol Titration to Effect for Procedural Sedation

University of Florida

Status: Completed

Conditions: Unconsciousness; Apnea, Postanesthetic; Sedative Overdose; Hypoxemia

Treatments: Procedure: Titrate propofol monotherapy infusion to effect

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03290859

OCR18882 (Other Identifier)

UL1TR001427 (U.S. NIH Grant/Contract)

IRB201701064 - N

Details and patient eligibility

About

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

Full 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.

Enrollment: 2,780 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

2,780 participants in 2 patient groups

Training intervention

Description:

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.

Treatment:

Procedure: Titrate propofol monotherapy infusion to effect

Effectiveness of training intervention

Description:

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