Efficacy and Safety Study of Two Propofol Formulations

February 22, 2008 updated by: B. Braun Melsungen AG

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

220

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Propofol MCT/LCT
Drug: Propofol
  • intravenous (total intravenous anaesthesia)
  • induction and maintenance
Other Names:
  • Diprivan 1%
  • Propofol Lipuro 1%
ACTIVE_COMPARATOR: 2
Propofol LCT
Drug: Propofol
  • intravenous (total intravenous anaesthesia)
  • induction and maintenance
Other Names:
  • Diprivan 1%
  • Propofol Lipuro 1%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
time to loss of eyelash reflex
Time Frame: induction of anaesthesia
induction of anaesthesia
doses required for induction of anaesthesia until loss of eyelash reflex
Time Frame: induction of anaesthesia
induction of anaesthesia

Secondary Outcome Measures

Outcome Measure
Time Frame
patient data/history
Time Frame: during anaesthesia
during anaesthesia
pre- and concomitant medication
Time Frame: during anaesthesia
during anaesthesia
anaesthesia relating data
Time Frame: during anaesthesia
during anaesthesia
recovery data
Time Frame: during anaesthesia
during anaesthesia
drug safety data (e.g. haemodynamics and clinical outcome)
Time Frame: during anaesthesia
during anaesthesia
adverse events
Time Frame: during anaesthesia
during anaesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

B. Braun Melsungen AG

Collaborators

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

Investigators

  • Principal Investigator: Zhanggang Xue, Prof, Shanghai Zhongshan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (ACTUAL)

October 1, 2007

Study Completion (ACTUAL)

October 1, 2007

Study Registration Dates

First Submitted

July 24, 2007

First Submitted That Met QC Criteria

July 24, 2007

First Posted (ESTIMATE)

July 25, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

February 25, 2008

Last Update Submitted That Met QC Criteria

February 22, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006L00667

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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