Ignite Creation Date:
2024-05-05 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00506246
Status:
COMPLETED
Last Update Posted:
2008-02-25
First Post:
2007-07-24
Brief Title:
Efficacy and Safety Study of Two Propofol Formulations
Sponsor:
B Braun Melsungen AG
Organization:
B Braun Melsungen AG
Study Overview
Official Title:
A Multi-Center Randomized Double-Blind Positive Controlled Study to Evaluate the Efficacy and Safety of PropofolPropofol-Lipuro in Total Intravenous Anaesthesia
Status:
COMPLETED
Status Verified Date:
2008-02
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 the study to compare Propofol-MCTLCT with LCT in terms of their efficacy and safety during total intravenous anaesthesia
Detailed Description:
Propofol chemical substance 2 6-Diisopropylphenol is a short-acting intravenous general anaesthetic which is used for induction and maintenance of a general anaesthesia for long-term sedation of ventilated intensive care patients or for short-term sedation in diagnostic and surgical procedures As an active substance propofol produces good and readily controlled anaesthesia with smooth and problem-free recovery both in adult patients and in children over 1 month of age One potential advantage of this formulation is that the MCTLCT-emulsion reduces pain on injection a frequently reported adverse reaction with LCT-emulsions of propofol
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