Race-Specific Propofol Titration to Effect for Procedural Sedation

NCT ID: NCT03290859

Last Updated: 2019-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2780 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-05

Study Completion Date

2019-02-05

Brief Summary

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

Detailed Description

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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.

Conditions

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Unconsciousness Apnea, Postanesthetic Sedative Overdose Hypoxemia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Titrate propofol monotherapy infusion to effect

Intervention Type PROCEDURE

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.

No interventions assigned to this group

Interventions

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Titrate propofol monotherapy infusion to effect

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeffrey White, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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UF Health

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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UL1TR001427

Identifier Type: NIH

Identifier Source: secondary_id

View Link

OCR18882

Identifier Type: OTHER

Identifier Source: secondary_id

IRB201701064 - N

Identifier Type: -

Identifier Source: org_study_id

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