Ignite Creation Date:
2025-12-24 @ 2:17 PM
Ignite Modification Date:
2026-01-04 @ 5:54 AM
Study NCT ID:
NCT00690495
Status:
COMPLETED
Last Update Posted:
2012-01-05
First Post:
2008-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Use of a Modified Propofol Emulsion in Adults
Sponsor:
B. Braun Melsungen AG
Organization:
Study Overview
Official Title:
Prospective, Monocentric Controlled, Randomized, Double-blind Study to Compare the Two Different Propofol Emulsions Regarding Tolerability and Injection Pain During the Induction of Anesthesia in Adults
Status:
COMPLETED
Status Verified Date:
2012-01
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 is to determine whether a modified propofol preparation shows any effect on the incidence of injection pain in adults undergoing elective surgery under general anesthesia.
Study hypothesis: The use of a modified propofol preparation will reduce the incidence of injection pain in the study group.
Study hypothesis: The use of a modified propofol preparation will reduce the incidence of injection pain in the study group.
Detailed Description:
Pain on injection is a most frequently reported side effect associated with the use of propofol for induction of anesthesia. Various measures have been taken to reduce the pain on injection, e.g. administration of lidocaine or fentanyl prior to propofol administration, mixture of lidocaine and propofol as well as cooling of the emulsion. Although pain on injection had been reduced with some of the above mentioned methods, they may not be regarded as a satisfactory solution of the problem.
Study Oversight
Has Oversight DMC:
False
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?: