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Efficacy and Safety Study of Two Propofol Formulations

This study has been completed.
Sponsor:
Collaborators:
B. Braun Medical SA
Shanghai Tigermed Consulting Co. Ltd
Information provided by:
B. Braun Melsungen AG
ClinicalTrials.gov Identifier:
NCT00506246
First received: July 24, 2007
Last updated: February 22, 2008
Last verified: February 2008
History of Changes

July 24, 2007
February 22, 2008
June 2007
October 2007   (final data collection date for primary outcome measure)
  • time to loss of eyelash reflex [ Time Frame: induction of anaesthesia ]
  • doses required for induction of anaesthesia until loss of eyelash reflex [ Time Frame: induction of anaesthesia ]
-time to loss of eyelash reflex -doses required for induction of anaesthesia until loss of eyelash reflex [ Time Frame: induction of anaesthesia ]
Complete list of historical versions of study NCT00506246 on ClinicalTrials.gov Archive Site
  • patient data/history [ Time Frame: during anaesthesia ]
  • pre- and concomitant medication [ Time Frame: during anaesthesia ]
  • anaesthesia relating data [ Time Frame: during anaesthesia ]
  • recovery data [ Time Frame: during anaesthesia ]
  • drug safety data (e.g. haemodynamics and clinical outcome) [ Time Frame: during anaesthesia ]
  • adverse events [ Time Frame: during anaesthesia ]
-patient data / history -pre- and concomitant medication -anaesthesia relating data -recovery data -drug safety data (e.g. haemodynamics and clinical outcome) -adverse events [ Time Frame: during anaesthesia ]
Not Provided
Not Provided
 
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

The purpose of the study to compare Propofol-MCT/LCT with LCT in terms of their efficacy and safety during total intravenous anaesthesia

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • General Anaesthesia
  • Induction of Anaesthesia
Drug: Propofol
  • intravenous (total intravenous anaesthesia)
  • induction and maintenance
Other Names:
  • Propofol Lipuro 1%
  • Diprivan 1%
  • Experimental: 1
    Propofol MCT/LCT
    Intervention: Drug: Propofol
  • Active Comparator: 2
    Propofol LCT
    Intervention: Drug: Propofol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
220
October 2007
October 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Female and male adult patients, and at least 18 and maximal 65 years of age;
  • ASA-classification I to II;
  • Undergoing an elective surgery, the anaesthesia is expected to last at least 1 hour and no more than 3 hours;
  • Will be under total intravenous anaesthesia;
  • Willing to give their signed informed consent.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00506246
2006L00667
No
Not Provided
B. Braun Melsungen AG
  • B. Braun Medical SA
  • Shanghai Tigermed Consulting Co. Ltd
Principal Investigator: Zhanggang Xue, Prof Zhongshan Hospital affiliated to Fudan University
B. Braun Melsungen AG
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP