Ignite Creation Date:
2024-05-06 @ 7:03 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05870514
Status:
RECRUITING
Last Update Posted:
2023-07-05
First Post:
2023-05-12
Brief Title:
Efficacy and Safety of Fospropofol Disodium Versus Propofol for Deep Sedation in Critically Ill Patients
Sponsor:
Xiaobo Yang MD
Organization:
Wuhan Union Hospital China
Study Overview
Official Title:
Efficacy and Safety of Fospropofol Disodium Versus Propofol for Deep Sedation in Critically Ill Patients
Status:
RECRUITING
Status Verified Date:
2023-07
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:
The purpose of this study is to evaluate the efficacy and safety of fospropofol disodium for injection compared to propofol for deep sedation in mechanically ventilated ICU patients
Detailed Description:
This is a randomized open-label small sample study using fospropofol disodium and propofol for deep sedation in mechanically ventilated ICU patients Subjects are randomized to different treatment groups including 1 for fospropofol disodium and 1 for propofol Remifentanil is co-administered with fospropofol or propofol Efficacy and safety profiles of fospropofol disodium and propofol are to be monitoted
Study Oversight
Has Oversight DMC:
None
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?:
None