NCT00690495

Use of a Modified Propofol Emulsion in Adults

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: B. Braun Melsungen AG · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Anesthesia

Interventions

Type	Name	Description
DRUG	Propofol	Propofol (drug), intravenous, induction of anesthesia
DRUG	Propofol 1%	Propofol (drug), intravenous, induction of anesthesia

Timeline

• Start date: 2008-05-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2008-06-04
• Last updated: 2012-01-05
• Results posted: 2011-09-22

Locations

1 site across 1 country: Germany