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Efficacy and Safety Study of Two Propofol Formulations

Sponsor
B. Braun Melsungen AG (Industry)
Overall Status
Completed
CT.gov ID
NCT00506246
Collaborator
B. Braun Medical International Trading Company Ltd. (Industry), Tigermed Consulting Co., Ltd (Industry)
220
Enrollment
3
Locations
2
Arms
4
Duration (Months)
73.3
Patients Per Site
18.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 3

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
220 participants
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
Study Start Date :
Jun 1, 2007
Actual Primary Completion Date :
Oct 1, 2007
Actual Study Completion Date :
Oct 1, 2007

Arms and Interventions

Arm Intervention/Treatment
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%

    		•

    Outcome Measures

    Primary Outcome Measures

    1. time to loss of eyelash reflex [induction of anaesthesia]

    2. doses required for induction of anaesthesia until loss of eyelash reflex [induction of anaesthesia]

    Secondary Outcome Measures

    1. patient data/history [during anaesthesia]

    2. pre- and concomitant medication [during anaesthesia]

    3. anaesthesia relating data [during anaesthesia]

    4. recovery data [during anaesthesia]

    5. drug safety data (e.g. haemodynamics and clinical outcome) [during anaesthesia]

    6. adverse events [during anaesthesia]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Pekin Union Medical College Hospital Beijing China
    2 Renji Hospital Affiliated to Shanghai Jiaotong University Shanghai China
    3 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00506246
    Other Study ID Numbers:
    • 2006L00667
    First Posted:
    Jul 25, 2007
    Last Update Posted:
    Feb 25, 2008
    Last Verified:
    Feb 1, 2008
    Keywords provided by , ,
    anaesthesia
    Additional relevant MeSH terms:
    Propofol

    Study Results

    No Results Posted as of Feb 25, 2008