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Completed

NCT Number: NCT00506246

Efficacy and Safety Study of Two Propofol Formulations

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

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Key information

Conditions

General Anaesthesia Induction of Anaesthesia

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pekin Union Medical College Hospital, Beijing, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Propofol

Drug
  • intravenous (total intravenous anaesthesia)
  • induction and maintenance

Other names: Propofol Lipuro 1%, Diprivan 1%

Primary outcomes

  1. time to loss of eyelash reflex

    Time frame: induction of anaesthesia

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

    Time frame: induction of anaesthesia

Secondary outcomes

  1. patient data/history

    Time frame: during anaesthesia

  2. pre- and concomitant medication

    Time frame: during anaesthesia

  3. anaesthesia relating data

    Time frame: during anaesthesia

  4. recovery data

    Time frame: during anaesthesia

  5. drug safety data (e.g. haemodynamics and clinical outcome)

    Time frame: during anaesthesia

  6. adverse events

    Time frame: during anaesthesia

Sponsors and collaborators

Lead sponsor

B. Braun Melsungen AG

Industry

Collaborators

  • B. Braun Medical International Trading Company Ltd.
  • Tigermed Consulting Co., Ltd

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Jul 25, 2007
Registry last updated
Feb 25, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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