Nanoemulsion and Lipid Emulsion of Propofol in a Non-invasive Ambulatory Procedures Children
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Cristália Produtos Químicos Farmacêuticos Ltda..
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Cristália Produtos Químicos Farmacêuticos Ltda.
Collaborator:
Instituto de Medicina Integral Professor Fernando Figueira - IMIP
Information provided by:
Cristália Produtos Químicos Farmacêuticos Ltda.
ClinicalTrials.gov Identifier:
NCT01326078
First received: March 28, 2011
Last updated: March 29, 2011
Last verified: March 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Bone Marrow Biopsy |
Drug: propofol |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Supportive Care |
| Official Title: | Comparison of Nanoemulsion of Propofol and Lipid Emulsion of Propofol in a Non-invasive Ambulatory Procedures Children |
Resource links provided by NLM:
Further study details as provided by Cristália Produtos Químicos Farmacêuticos Ltda.:
Primary Outcome Measures:
- Classification of the sedation level [ Time Frame: time 0 ] [ Designated as safety issue: Yes ]Instantly after the loss of consciousness (loss of corneal-palpebral reflex)will be measure the sedation using the Ramsay Modified Scale
Secondary Outcome Measures:
- Time of latency [ Time Frame: 3-10 seconds ] [ Designated as safety issue: No ]Time between the injection and loss of the corneal-palpebral reflex
- pain at injection [ Time Frame: 3 - 10 seconds: during the injection ] [ Designated as safety issue: No ]The pain will be measure using the CHEOPS scale during the injection of propofol.
- hematologist satisfaction [ Time Frame: 12 hours: end of procedure ] [ Designated as safety issue: No ]The hematolgist will evaluate the sedation of propofol by responding the questionnaire.
- Awakening time [ Time Frame: 10 hours: when the patient awakes ] [ Designated as safety issue: No ]time between the last dose of propofol and the time when the patient awakes (crys, opens eyes, and moves.
- Total dose [ Time Frame: 12 - hours End of procedure ] [ Designated as safety issue: No ]The total dose use will be measure in mg/kg/hour
- Incidence of Adverse Events [ Time Frame: 0 to 14 hours ] [ Designated as safety issue: No ]The incidence of adverse events will be measure during the anesthethic induction and 12 hours after the procedures.
| Estimated Enrollment: | 30 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: propofol nanoemulsion
3-4 mg/kg of propofol nanoemulsion will be administered by 1mL per 5 seconds, adjustment dose can be given.
|
Drug: propofol
3 - 4 mg/kg IV, adjustment dose if necessary
|
|
Active Comparator: propofol lipid emulsion
3-4 mg/kg will be administered by 1 ml per 5 seconds.
|
Drug: propofol
3 - 4 mg/kg IV, adjustment dose if necessary
|
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.
Eligibility| Ages Eligible for Study: | 6 Years to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Lumbar Puncture or bone marrow biopsy
- Peripheral Intravenous access available on dorsal regional hand
- Parents or responsible for the child consent participation.
Exclusion Criteria:
- Relative or absolute contraindications use of propofol and excipients
- Contraindications of general anesthesia or sedation with propofol
- Allergy to derived from egg or soy
- Use of pre-medication
- Patient receiving psychotropic drugs
- Use of opioid within 24 hours
- The responsible for the children unable to decide, or doesn´t have condition
- State of compromised vital functions such as ventilation and hemodynamic balance
- Liver cancer
- Changes in the safety exams
- Others comorbidity in the investigator opinion
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01326078
Contacts
| Contact: Luciana C Lima, PhD | lulima1@hotmail.com | |
| Contact: Hugo Praxedes | hugo@cristalia.com.br |
Sponsors and Collaborators
Cristália Produtos Químicos Farmacêuticos Ltda.
Instituto de Medicina Integral Professor Fernando Figueira - IMIP
Investigators
| Principal Investigator: | Luciana C Lima, PhD | IMIP |
More Information
No publications provided
| Responsible Party: | Hugo Praxedes, Cristália Produtos Químicos Farmacêuticos Ltda |
| ClinicalTrials.gov Identifier: | NCT01326078 History of Changes |
| Other Study ID Numbers: | CRIST011 |
| Study First Received: | March 28, 2011 |
| Last Updated: | March 29, 2011 |
| Health Authority: | Brazil: Ethics Committee Brazil: National Health Surveillance Agency |
Keywords provided by Cristália Produtos Químicos Farmacêuticos Ltda.:
|
sedation children leukemia bone marrow biopsy |
Additional relevant MeSH terms:
|
Leukemia Neoplasms by Histologic Type Neoplasms Propofol Anesthetics, Intravenous Anesthetics, General Anesthetics |
Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Hypnotics and Sedatives |
ClinicalTrials.gov processed this record on May 21, 2013