NCT00506246

Efficacy and Safety Study of Two Propofol Formulations

A Multi-Center, Randomized, Double-Blind, Positive Controlled Study to Evaluate the Efficacy and Safety of Propofol(Propofol®-Lipuro) in Total Intravenous Anaesthesia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: B. Braun Melsungen AG · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study to compare Propofol-MCT/LCT 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 MCT/LCT-emulsion reduces pain on injection, a frequently reported adverse reaction with LCT-emulsions of propofol.

Conditions

• General Anaesthesia
• Induction of Anaesthesia

Interventions

Type	Name	Description
DRUG	Propofol	* intravenous (total intravenous anaesthesia) * induction and maintenance

Timeline

• Start date: 2007-06-01
• Primary completion: 2007-10-01
• Completion: 2007-10-01
• First posted: 2007-07-25
• Last updated: 2008-02-25

Locations

3 sites across 1 country: China