Race-Specific Propofol Titration to Effect for Procedural Sedation

Hypoxemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03290859
• Other study ID #: IRB201701064 - N
• Secondary ID: UL1TR001427OCR18
• Status: Completed
• Start date: January 5, 2018
• Est. completion date: February 5, 2019

Study information

• Verified date: October 2019
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2780
• Est. completion date: February 5, 2019
• Est. primary completion date: February 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea, Postanesthetic
• Hypoxemia
• Hypoxia
• Sedative Overdose
• Unconsciousness

Intervention

Procedure:
• Titrate propofol monotherapy infusion to effect
Train anesthesia providers in a standardized protocol for titrating propofol infusion to effect.

Locations

Country	Name	City	State
United States	UF Health	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Center for Advancing Translational Science (NCATS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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