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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
  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
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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:

Drug Information available for: Propofol
U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00506246

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

No publications provided

ClinicalTrials.gov Identifier: NCT00506246     History of Changes
Other Study ID Numbers: 2006L00667
Study First Received: July 24, 2007
Last Updated: February 22, 2008
Health Authority: China: Food and Drug Administration

Keywords provided by B. Braun Melsungen AG:
anaesthesia

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

ClinicalTrials.gov processed this record on May 16, 2013