General AnesthesiaPhase 3PropofolTENCT01856998
Therapeutic Equivalence (TE) Study of Propofol 2% MCT Fresenius (MCT=Medium-Chain Triglycerides) Compared With Diprivan® in Patients Undergoing Elective Surgery
A Phase 3 study testing Propofol and Diprivan in people with General Anesthesia and Elective Surgery, run by Fresenius Kabi at 1 site in France.
Trial summary
The purpose of this study is to evaluate the therapeutic equivalence, based on pharmacodynamic parameters of Propofol 2% (20 mg/mL) MCT Fresenius and Diprivan® 20 mg/mL (AstraZeneca), administered by target controlled infusion (TCI). Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- General Anesthesia, Elective Surgery
- What is being tested?
- Propofol and Diprivan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteFrance
- Study dates
- May 2013to Feb 2014
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female subjects ≥18 years and <65 years old
- Able to understand and give signed and dated written informed consent
- Body mass index (BMI) ≥20 and ≤30 kg/m² at screening
- ASA (American Society of Anesthesiologists) physical status 1 or 2
- Undergoing elective, minor orthopedic, vascular, urological, or gynecological surgery
- Patients should be affiliated to a social security scheme and benefit from the corresponding rights and cover
Who cannot join
- The following planned procedures are to be excluded:
- Day surgery
- Emergency surgery
- Total hip or total knee replacement
- Requiring opening of the great cavities of the body (cranium, thorax, peritoneum, or pelvis)
- With routine risk, even if low, of hemorrhage severe enough to require administration of colloid or blood products
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- With routine risk, even if low, of death during or soon after the procedure
- Vascular surgery involving the aorta, venae cavae, iliac arteries, or femoral arteries
- Intended administration of IV medications through a central venous catheter (Note: a central venous catheter may be used to obtain Pharmacokinetic (PK) samples, though only if no port of the catheter is being used for administration of any other product, including crystalloid infusion at more than a "keep line open" rate)
- Administration of general anesthesia or propofol within the 7 days prior to randomization
- History of hypersensitivity to propofol, eggs, soya, peanuts, or any other constituent of the study drugs
- ASA physical status ≥3
- History of major anesthesia complications including, but not limited to:
- Clinically significant hypoxia
- Profound hypotension
- Anaphylaxis or anaphylactic reactions
- Unpredictable anesthesia agent requirements
- History of difficult airway management including, but not limited to:
- Problematic artificial ventilation with face mask
- Repeated difficulty of placement of laryngeal mask airway (LMA)
- Difficult laryngeal intubation (Cormack-Lehane grade 3 to 4) and requiring alternative technique e.g. fibre-optic or awake laryngeal intubation
- History of difficult venous access
- Myocardial infarction within 6 months of randomization or a cardiac reperfusion procedure within 6 weeks of randomization
- Significant respiratory, cardiovascular, liver or renal disease as assessed by investigator
- Active systemic infection (localized infection related to surgical procedure is allowable as long as there is no indication of systemic involvement)
- History of psychiatric disorder, including use of sedatives or antidepressants for any reason, within 6 months prior to randomization
- Alcohol or other substance abuse within 2 years prior to randomization, as well as for the duration of the study
- Use of medication that could reduce the subject's respiratory and/or cardiac output
- Female subjects who are pregnant, breastfeeding, or lactating
- Hemoglobin <7.5 g/dL at screening or randomization
- Platelets <50,000 x 10³/μL at screening or randomization
- ECG findings detected at screening not consistent with the subject's medical history or warranting cardiology review
- Participation in an interventional clinical study within 6 months of screening
- History of Propofol infusion syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Therapeutic Equivalence Study of Propofol Using Target-Controlled Infusion of Propofol 2% (20 mg/mL) MCT Fresenius Compared With Diprivan® 20 mg/mL (AstraZeneca) in Patients Undergoing Elective Surgery
The purpose of this study is to evaluate the therapeutic equivalence, based on pharmacodynamic parameters of Propofol 2% (20 mg/mL) MCT Fresenius and Diprivan® 20 mg/mL (AstraZeneca), administered by target controlled infusion (TCI).
- Conditions
- General Anesthesia, Elective Surgery
- Being tested
- Propofol, Diprivan
- Keywords
- Therapeutic Equivalence, Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
DiprivanDrug
| Study group | Role | What they receive |
|---|---|---|
| Diprivan® 20 mg/mL (AstraZeneca) | Active comparator | Dosage form: lipid emulsion
Dosage: Initial effect-site target concentration: 5 μg/mL, if necessary increased by 1 μg/mL every 60 seconds until LOER
Frequency: continuously (will be adjusted to keep Bispectral Index (BIS) between 40 and 60, however maintenance target concentration can be increased if a patient needs a BIS <40 with regard to individual condition and the respective surgery)
Duration: Until end of surgery Receives: Drug: Diprivan |
| Propofol 2% (20 mg/mL) MCT Fresenius | Experimental | Dosage form: lipid emulsion
Dosage: Initial effect-site target concentration: 5 μg/mL, if necessary increased by 1 μg/mL every 60 seconds until LOER
Frequency: continuously (will be adjusted to keep Bispectral Index (BIS) between 40 and 60, however maintenance target concentration can be increased if a patient needs a BIS <40 with regard to individual condition and the respective surgery)
Duration: Until end of surgery 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 (LOER)
The overall timeframe until LOER is observed depends on the patient and varies from only a few seconds up to 240 seconds in total.
Measured: Every ten seconds from the initiation of TCI anesthesia device until LOER occurs up to 150 seconds. If LOER has not occurred within this timeframe, target propofol concentration to be increased by 1 μg/mL every 60 seconds until LOER is observed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2013 (estimated)
- Study startMay 2013
- Primary completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnesthesiaStudies 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
- Who is masked
- Participant, Investigator
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Kabi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Responsible party
- Sponsor
- Investigators
- Francois Sztark, Professor, Principal investigator, CHU de Bordeaux, Groupe Hospitalier Pellegrin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01856998
- Sponsor's protocol ID
- PROP-001-CP3
- Other IDs
- 2012-005701-43
- Acronym
- PropofolTE
- Status last verified
- Feb 2014
- First submitted
- 8 May 2013
- Last updated
- 21 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Equivalence Study of Propofol Using Target-Controlled Infusion of Propofol 2% (20 mg/mL) MCT Fresenius Compared With Diprivan® 20 mg/mL (AstraZeneca) in Patients Undergoing Elective Surgery
- ClinicalTrials.gov ID
- NCT01856998
- Acronym / sponsor ID
- PropofolTE / PROP-001-CP3
- Conditions
- General Anesthesia, Elective Surgery
- Keywords
- Therapeutic Equivalence, Propofol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Fresenius KabiIndustry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Study start
- May 2013
- Primary completion
- Feb 2014 (actual)
- First posted
- 20 May 2013 (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 this study is to evaluate the therapeutic equivalence, based on pharmacodynamic parameters of Propofol 2% (20 mg/mL) MCT Fresenius and Diprivan® 20 mg/mL (AstraZeneca), administered by target controlled infusion (TCI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diprivan® 20 mg/mL (AstraZeneca) | Active comparator | Drug: DiprivanDosage form: lipid emulsion Dosage: Initial effect-site target concentration: 5 μg/mL, if necessary increased by 1 μg/mL every 60 seconds until LOER Frequency: continuously (will be adjusted to keep Bispectral Index (BIS) between 40 and 60, however maintenance target concentration can be increased if a patient needs a BIS <40 with regard to individual condition and the respective surgery) Duration: Until end of surgery |
| Propofol 2% (20 mg/mL) MCT Fresenius | Experimental | Drug: PropofolDosage form: lipid emulsion Dosage: Initial effect-site target concentration: 5 μg/mL, if necessary increased by 1 μg/mL every 60 seconds until LOER Frequency: continuously (will be adjusted to keep Bispectral Index (BIS) between 40 and 60, however maintenance target concentration can be increased if a patient needs a BIS <40 with regard to individual condition and the respective surgery) Duration: Until end of surgery |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male or female subjects ≥18 years and <65 years old
- Able to understand and give signed and dated written informed consent
- Body mass index (BMI) ≥20 and ≤30 kg/m² at screening
- ASA (American Society of Anesthesiologists) physical status 1 or 2
- Undergoing elective, minor orthopedic, vascular, urological, or gynecological surgery
Key exclusion criteria (34 listed)
- The following planned procedures are to be excluded:
- Intended administration of IV medications through a central venous catheter (Note: a central venous catheter may be used to obtain Pharmacokinetic (PK) samples, though only if no port of the catheter is being used for administration of any other product, including crystalloid infusion at more than a "keep line open" rate)
- Administration of general anesthesia or propofol within the 7 days prior to randomization
- History of hypersensitivity to propofol, eggs, soya, peanuts, or any other constituent of the study drugs
- ASA physical status ≥3
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 |
|---|---|---|
| Propofol | Drug | Propofol 2% (20 mg/mL) MCT Fresenius |
| Diprivan | Drug | Diprivan® 20 mg/mL (AstraZeneca) |
Primary outcome
Time to Loss of Eyelash Reflex (LOER)
Time frame: Every ten seconds from the initiation of TCI anesthesia device until LOER occurs up to 150 seconds. If LOER has not occurred within this timeframe, target propofol concentration to be increased by 1 μg/mL every 60 seconds until LOER is observed.
The overall timeframe until LOER is observed depends on the patient and varies from only a few seconds up to 240 seconds in total.
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 21 Feb 2014.
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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.
Francois Sztark, Professor principal investigator
CHU de Bordeaux, Groupe Hospitalier Pellegrin
1 site 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 and Diprivan in people with General Anesthesia and Elective Surgery, run by Fresenius Kabi at 1 site in France.
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 6 inclusion and 34 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 21 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 (LOER) (time frame: Every ten seconds from the initiation of TCI anesthesia device until LOER occurs up to 150 seconds. If LOER has not occurred within this timeframe, target propofol concentration to be increased by 1 μg/mL every 60 seconds until LOER is observed.). 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 21 Feb 2014.