Ignite Creation Date:
2025-12-24 @ 2:41 PM
Ignite Modification Date:
2026-01-07 @ 2:23 AM
Study NCT ID:
NCT03290859
Status:
COMPLETED
Last Update Posted:
2019-10-25
First Post:
2017-09-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Race-Specific Propofol Titration to Effect for Procedural Sedation
Sponsor:
University of Florida
Organization:
Study Overview
Official Title:
Pragmatic Clinical Trial of Race-Specific Response to Propofol Infusion Titrated to Effect for Procedural Sedation During Endoscopy
Status:
COMPLETED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Prospectively evaluate newly established guidelines and make clinicians aware of inter-racial difference in propofol sensitivity.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| UL1TR001427 | NIH | None | https://reporter.nih.gov/quic… | View |
| OCR18882 | OTHER | University of Florida | View |