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Efficacy and Safety Study of Two Propofol Formulations

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00506246
First Posted: July 25, 2007
Last Update Posted: February 25, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
B. Braun Medical International Trading Company Ltd.
Tigermed Consulting Co., Ltd
Information provided by:
B. Braun Melsungen AG
  Purpose
The purpose of the study to compare Propofol-MCT/LCT with LCT in terms of their efficacy and safety during total intravenous anaesthesia

Condition Intervention Phase
General Anaesthesia Induction of Anaesthesia Drug: Propofol Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Multi-Center, Randomized, Double-Blind, Positive Controlled Study to Evaluate the Efficacy and Safety of Propofol(Propofol®-Lipuro) in Total Intravenous Anaesthesia

Resource links provided by NLM:


Further study details as provided by B. Braun Melsungen AG:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 220
Study Start Date: June 2007
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Propofol MCT/LCT
Drug: Propofol
  • intravenous (total intravenous anaesthesia)
  • induction and maintenance
Other Names:
  • Propofol Lipuro 1%
  • Diprivan 1%
Active Comparator: 2
Propofol LCT
Drug: Propofol
  • intravenous (total intravenous anaesthesia)
  • induction and maintenance
Other Names:
  • Propofol Lipuro 1%
  • Diprivan 1%

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00506246


Locations
China
Pekin Union Medical College Hospital
Beijing, China
Renji Hospital Affiliated to Shanghai Jiaotong University
Shanghai, China
Zhongshan Hospital affiliated to Fudan University
Shanghai, China
Sponsors and Collaborators
B. Braun Melsungen AG
B. Braun Medical International Trading Company Ltd.
Tigermed Consulting Co., Ltd
Investigators
Principal Investigator: Zhanggang Xue, Prof Shanghai Zhongshan Hospital
  More Information

ClinicalTrials.gov Identifier: NCT00506246     History of Changes
Other Study ID Numbers: 2006L00667
First Submitted: July 24, 2007
First Posted: July 25, 2007
Last Update Posted: February 25, 2008
Last Verified: February 2008

Keywords provided by B. Braun Melsungen AG:
anaesthesia

Additional relevant MeSH terms:
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics