General AnaesthesiaPhase 3NCT00506246
Efficacy and Safety Study of Two Propofol Formulations
A Phase 3 study testing Propofol in people with General Anaesthesia and Induction of Anaesthesia, run by B. Braun Melsungen AG at 3 sites in China.
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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- General Anaesthesia, Induction of Anaesthesia
- What is being tested?
- Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 3 sitesChina
- Study dates
- Jun 2007to Oct 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Pekin Union Medical College Hospital
Beijing
Renji Hospital Affiliated to Shanghai Jiaotong University
Shanghai
Zhongshan Hospital affiliated to Fudan University
Shanghai
About this 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
The purpose of the study to compare Propofol-MCT/LCT with LCT in terms of their efficacy and safety during total intravenous anaesthesia
Read the 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.
- Conditions
- General Anaesthesia, Induction of Anaesthesia
- Being tested
- Propofol
- Keywords
- anaesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Also called Propofol Lipuro 1%, Diprivan 1%
- intravenous (total intravenous anaesthesia)
- induction and maintenance
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Propofol MCT/LCT Receives: Drug: Propofol |
| 2 | Active comparator | Propofol LCT Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to loss of eyelash reflex
Measured: induction of anaesthesia
doses required for induction of anaesthesia until loss of eyelash reflex
Measured: induction of anaesthesia
Secondary outcomes (6)
patient data/history
Measured: during anaesthesia
pre- and concomitant medication
Measured: during anaesthesia
anaesthesia relating data
Measured: during anaesthesia
recovery data
Measured: during anaesthesia
drug safety data (e.g. haemodynamics and clinical outcome)
Measured: during anaesthesia
adverse events
Measured: during anaesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2007 (estimated)
- Study startJun 2007
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnaesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- B. Braun Melsungen AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- B. Braun Medical International Trading Company Ltd., Tigermed Consulting Co., Ltd
- Investigators
- Zhanggang Xue, Prof, Principal investigator, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00506246
- Sponsor's protocol ID
- 2006L00667
- Status last verified
- Feb 2008
- First submitted
- 24 Jul 2007
- Last updated
- 25 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00506246
- Acronym / sponsor ID
- 2006L00667
- Conditions
- General Anaesthesia, Induction of Anaesthesia
- Keywords
- anaesthesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- B. Braun Melsungen AGIndustry (pharma, biotech, devices)
- Collaborators
- B. Braun Medical International Trading Company Ltd., Tigermed Consulting Co., Ltd
- Study start
- Jun 2007
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 25 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study to compare Propofol-MCT/LCT with LCT in terms of their efficacy and safety during total intravenous anaesthesia
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: PropofolPropofol MCT/LCT |
| 2 | Active comparator | Drug: PropofolPropofol LCT |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropofolAlso: Propofol Lipuro 1%, Diprivan 1%* intravenous (total intravenous anaesthesia) * induction and maintenance | Drug | 1, 2 |
Primary outcome
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
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhanggang Xue, Prof principal investigator
Shanghai Zhongshan Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Propofol in people with General Anaesthesia and Induction of Anaesthesia, run by B. Braun Melsungen AG at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to loss of eyelash reflex (time frame: induction of anaesthesia). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2008.