Efficacy and Safety Study of Two Propofol Formulations

General Anaesthesia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00506246
• Other study ID #: 2006L00667
• Status: Completed
• Phase: Phase 3
• First received: July 24, 2007
• Last updated: February 22, 2008
• Start date: June 2007
• Est. completion date: October 2007

Study information

• Verified date: February 2008
• Source: B. Braun Melsungen AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• General Anaesthesia
• Induction of Anaesthesia

Intervention

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

Locations

Country	Name	City	State
China	Pekin Union Medical College Hospital	Beijing
China	Renji Hospital Affiliated to Shanghai Jiaotong University	Shanghai
China	Zhongshan Hospital affiliated to Fudan University	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
B. Braun Melsungen AG	B. Braun Medical International Trading Company Ltd., Tigermed Consulting Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to loss of eyelash reflex		induction of anaesthesia
Primary	doses required for induction of anaesthesia until loss of eyelash reflex		induction of anaesthesia
Secondary	patient data/history		during anaesthesia
Secondary	pre- and concomitant medication		during anaesthesia
Secondary	anaesthesia relating data		during anaesthesia
Secondary	recovery data		during anaesthesia
Secondary	drug safety data (e.g. haemodynamics and clinical outcome)		during anaesthesia
Secondary	adverse events		during anaesthesia