Efficacy and Safety Study of Two Propofol Formulations - Full Text View

Sponsors and Collaborators:	B. Braun Melsungen AG B. Braun Medical (Shanghai) International Trading Corp. Ltd. Shanghai Tigermed Consulting Co. Ltd
Information provided by:	B. Braun Melsungen AG
ClinicalTrials.gov Identifier:	NCT00506246

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 III

MedlinePlus related topics: Anesthesia

Drug Information available for: Propofol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Bio-equivalence Study
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

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
1: Experimental Propofol MCT/LCT	Drug: Propofol intravenous (total intravenous anaesthesia) induction and maintenance
2: Active Comparator Propofol LCT	Drug: Propofol intravenous (total intravenous anaesthesia) induction and maintenance

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
Zhongshan Hospital affiliated to Fudan University
Shanghai, China
Pekin Union Medical College Hospital
Beijing, China
Renji Hospital Affiliated to Shanghai Jiaotong University
Shanghai, China

Sponsors and Collaborators

B. Braun Melsungen AG

B. Braun Medical (Shanghai) International Trading Corp. Ltd.

Shanghai Tigermed Consulting Co. Ltd

Investigators

Principal Investigator:

Zhanggang Xue, Prof

Zhongshan Hospital affiliated to Fudan University

More Information

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

Keywords provided by B. Braun Melsungen AG:

anaesthesia

Study placed in the following topic categories:

Propofol

Additional relevant MeSH terms:

Anesthetics, Intravenous
Anesthetics, General
Therapeutic Uses
Hypnotics and Sedatives
Physiological Effects of Drugs

Central Nervous System Depressants
Anesthetics
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009