Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06573489
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-13
Brief Title:
Efficacy and Safety of Fospropofol in Adult Laparoscopic Surgery A Clinical Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Minimum Effective Dose and Maintenance Effectiveness of Fospropofol for General Anesthesia Induction in Adult Laparoscopic Abdominal Surgery A Randomized Single-Blind Clinical Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This protocol is a clinical study of fospropofol disodium for general anesthesia in adults undergoing laparoscope-assisted abdominal surgery The study has three main objectives First to explore the use of propofol disodium as the lowest effective dose for induction of general anesthesia Secondly to evaluate the efficacy and safety of fospropofol disodium in the maintenance phase of general anesthesia and to determine its effective dose range Finally the effects of fospropofol disodium on Bispectral Index during induction maintenance and recovery were studied and compared with propofol to understand its characteristic changes The randomized single-blind controlled design of the study with an expected enrollment of 373 patients was designed to achieve its objectives through a three-phase trial design to provide important clinical information about the safety and efficacy of the use of propofol disodium
Detailed Description:
1 To explore the lowest effective dose of fospropofol disodium for general anesthesia induction in adult laparoscopic abdominal surgery
2 Observation on efficacy safety and effective dose range of propofol disodium for general anesthesia maintenance in adult laparoscopic abdominal surgery
3 To study the changes of Bispectral Index in the brain of patients treated with propofol during induction maintenance and recovery of general anesthesia during laparoscopic abdominal surgery in adults and to compare with BISBispectral Index monitoring under propofol and to study the characteristic changes of BISBispectral Index waveform in patients treated with propofol disodium
2 Observation on efficacy safety and effective dose range of propofol disodium for general anesthesia maintenance in adult laparoscopic abdominal surgery
3 To study the changes of Bispectral Index in the brain of patients treated with propofol during induction maintenance and recovery of general anesthesia during laparoscopic abdominal surgery in adults and to compare with BISBispectral Index monitoring under propofol and to study the characteristic changes of BISBispectral Index waveform in patients treated with propofol disodium
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None