LeukemiaPhase 2/3NCT01326078
Use of Lipid Emulsion or Nanoemulsion of Propofol on Children Undergoing Ambulatory Invasive Procedures.
A Phase 2/3 study testing propofol in people with Leukemia, run by Cristália Produtos Químicos Farmacêuticos Ltda..
Trial summary
The purpose of this study is to compare the safety and efficacy of the of propofol nanoemulsion and lipid emulsion for sedation in non-invasive ambulatory procedures. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Leukemia
- 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
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2011to Dec 2011
- Phase
- Phase 2/3
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Lumbar Puncture or Myelogram
- Peripheral Intravenous access available in the veins on the dorsal region of the hand
- The informed consent signed by the legal responsible of the child allowing the participation in the study
Who cannot join
- Relative or absolute contraindications use of propofol and excipients
- Contraindications to the patient undergo general anesthesia or sedation with drug
- Allergy derived from egg or soy
- Use of pre-medication
- Patient receiving psychotropic drugs
- Use of opioid within 24 hours
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- The responsible for the children unable to decide for his participation
- The severity of the condition wich compromises vital functions such as ventilation and hemodynamic balance
- Liver cancer which compromises its function
- Changes in the blood tests
- Others comorbidities in the investigator opinion
About this study
Official title: Comparison Between Propofol Nanoemulsion and Propofol Lipid Emulsion on Children Undergoing Ambulatory Invasive Procedures.
The purpose of this study is to compare the safety and efficacy of the of propofol nanoemulsion and lipid emulsion for sedation in non-invasive ambulatory procedures.
Read the detailed description
Nanoemulsion of propofol has been developed without lipid solvent in the formulation to minimize the adverse events such as pain of injection, redness, heat, phlebitis.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofolDrug
3 - 4 mg/kg IV, adjustment dose if necessary
| Study group | Role | What they receive |
|---|---|---|
| propofol nanoemulsion | Experimental | 3-4 mg/kg of propofol nanoemulsion will be administered by 1mL per 5 seconds, adjustment dose can be given. Receives: Drug: propofol |
| propofol lipid emulsion | Active comparator | 3-4 mg/kg will be administered by 1 ml per 5 seconds. Receives: Drug: propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Classification of the sedation level
Instantly after the loss of consciousness (loss of corneal-palpebral reflex) will be measured the sedation using the Ramsay Modified Scale.
Measured: time 0
Secondary outcomes (6)
Time of latency
Time between the injection and loss of the corneal-palpebral reflex
Measured: 3-10 seconds
Pain at injection
The pain will be measured by CHEOPS Scale which evaluates the behavior of the child against pain.
Measured: 3 - 10 seconds: during the injection
Physician satisfaction
The satisfaction of the medical specialist will be assessed through a questionnaire that assesses conditions of sedation for the procedure.
Measured: 12 hours: end of procedure
Awakening time
Time between the last dose of propofol and the time when the patient awakes (cry, eyes opening and spontaneous movement).
Measured: 10 hours: when the patient awakes
Total dose
The total dose used will be measured in mg/kg/hour.
Measured: 12 - hours End of procedure
Incidence of Adverse Events
Adverse events will be compared in its incidence in the two formulations of propofol during the anesthetic induction and 12 hours after the procedures.
Measured: 0 to 14 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2011 (estimated)
- Study startJun 2011
- Primary completionJul 2011 (estimated)
- Study completionDec 2011 (estimated)
Why it stopped: The Sponsor has no interest in continuing the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies 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 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cristália Produtos Químicos Farmacêuticos Ltda.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Professor Fernando Figueira Integral Medicine Institute
- Responsible party
- Sponsor
- Investigators
- Luciana C Lima, PhD, Principal investigator, IMIP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01326078
- Sponsor's protocol ID
- CRIST011
- Status last verified
- Mar 2014
- First submitted
- 28 Mar 2011
- Last updated
- 26 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Propofol Nanoemulsion and Propofol Lipid Emulsion on Children Undergoing Ambulatory Invasive Procedures.
- ClinicalTrials.gov ID
- NCT01326078
- Acronym / sponsor ID
- CRIST011
- Conditions
- Leukemia
- Keywords
- sedation, children, leukemia, bone marrow biopsy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The Sponsor has no interest in continuing the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cristália Produtos Químicos Farmacêuticos Ltda.Industry (pharma, biotech, devices)
- Collaborators
- Professor Fernando Figueira Integral Medicine Institute
- Study start
- Jun 2011
- Primary completion
- Jul 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 30 Mar 2011 (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 compare the safety and efficacy of the of propofol nanoemulsion and lipid emulsion for sedation in non-invasive ambulatory procedures.
Detailed description
Nanoemulsion of propofol has been developed without lipid solvent in the formulation to minimize the adverse events such as pain of injection, redness, heat, phlebitis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| propofol nanoemulsion | Experimental | Drug: propofol3-4 mg/kg of propofol nanoemulsion will be administered by 1mL per 5 seconds, adjustment dose can be given. |
| propofol lipid emulsion | Active comparator | Drug: propofol3-4 mg/kg will be administered by 1 ml per 5 seconds. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Lumbar Puncture or Myelogram
- Peripheral Intravenous access available in the veins on the dorsal region of the hand
- The informed consent signed by the legal responsible of the child allowing the participation in the study
Key exclusion criteria (11 listed)
- Relative or absolute contraindications use of propofol and excipients
- Contraindications to the patient undergo general anesthesia or sedation with drug
- Allergy derived from egg or soy
- Use of pre-medication
- Patient receiving psychotropic drugs
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 |
|---|---|---|
| propofol3 - 4 mg/kg IV, adjustment dose if necessary | Drug | propofol lipid emulsion, propofol nanoemulsion |
Primary outcome
Classification of the sedation level
Time frame: time 0
Instantly after the loss of consciousness (loss of corneal-palpebral reflex) will be measured the sedation using the Ramsay Modified Scale.
6 secondary outcomes
Time of latency
Time frame: 3-10 seconds
Pain at injection
Time frame: 3 - 10 seconds: during the injection
Physician satisfaction
Time frame: 12 hours: end of procedure
Awakening time
Time frame: 10 hours: when the patient awakes
Total dose
Time frame: 12 - hours End of procedure
Incidence of Adverse Events
Time frame: 0 to 14 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 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.
Luciana C Lima, PhD principal investigator
IMIP
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing propofol in people with Leukemia, run by Cristália Produtos Químicos Farmacêuticos Ltda..
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 3 inclusion and 11 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: withdrawn, as of the sponsor's last update on 26 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Classification of the sedation level (time frame: time 0). 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 26 Mar 2014.