Ignite Creation Date:
2025-12-24 @ 1:39 PM
Ignite Modification Date:
2026-01-03 @ 8:06 PM
Study NCT ID:
NCT04226495
Status:
COMPLETED
Last Update Posted:
2024-12-11
First Post:
2020-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Sufentanil Infusion vs Sufentanil Bolus
Sponsor:
University of Nebraska
Organization:
Study Overview
Official Title:
Sufentanil Infusion vs Sufentanil Bolus and Time to Extubation During Routine Cardiac Surgery
Status:
COMPLETED
Status Verified Date:
2024-11
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:
Randomized single blind controlled clinical trial to test the benefit of sufentanil infusion over bolus dosing to reduce time to extubation and reduced length of ICU stay.
Detailed Description:
This study will compare Sufentanil bolus vs infusion and analyze which has a faster extubation time in participants who undergo routine cardiac surgery. The hypothesis is that routine cardiac surgery patients receiving sufentanil infusion will have a lower sufentanil concentration at the end of surgery and have a shorter time to extubation than participants receiving sufentanil bolus dosing even with similar total doses of sufentanil. The intervention will be Sufentanil infusion during surgery and evaluations will include Sufentanil blood concentrations, ICU and hospital length of stay and re-intubation rate. We will follow up with the participants through their ICU stay (primary objective) and hospital length of stay (secondary objective).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: