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Use of Lipid Emulsion or Nanoemulsion of Propofol on Children Undergoing Ambulatory Invasive Procedures.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01326078
Recruitment Status : Withdrawn (The Sponsor has no interest in continuing the study.)
First Posted : March 30, 2011
Last Update Posted : March 26, 2014
Professor Fernando Figueira Integral Medicine Institute
Information provided by (Responsible Party):
Cristália Produtos Químicos Farmacêuticos Ltda.

Brief 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.

Condition or disease Intervention/treatment Phase
Leukemia Drug: propofol Phase 2 Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Comparison Between Propofol Nanoemulsion and Propofol Lipid Emulsion on Children Undergoing Ambulatory Invasive Procedures.
Study Start Date : June 2011
Estimated Primary Completion Date : July 2011
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Time of latency [ Time Frame: 3-10 seconds ]
    Time between the injection and loss of the corneal-palpebral reflex

  2. Pain at injection [ Time Frame: 3 - 10 seconds: during the injection ]
    The pain will be measured by CHEOPS Scale which evaluates the behavior of the child against pain.

  3. Physician satisfaction [ Time Frame: 12 hours: end of procedure ]
    The satisfaction of the medical specialist will be assessed through a questionnaire that assesses conditions of sedation for the procedure.

  4. Awakening time [ Time Frame: 10 hours: when the patient awakes ]
    Time between the last dose of propofol and the time when the patient awakes (cry, eyes opening and spontaneous movement).

  5. Total dose [ Time Frame: 12 - hours End of procedure ]
    The total dose used will be measured in mg/kg/hour.

  6. Incidence of Adverse Events [ Time Frame: 0 to 14 hours ]
    Adverse events will be compared in its incidence in the two formulations of propofol during the anesthetic induction and 12 hours after the procedures.

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01326078

Sponsors and Collaborators
Cristália Produtos Químicos Farmacêuticos Ltda.
Professor Fernando Figueira Integral Medicine Institute
Principal Investigator: Luciana C Lima, PhD IMIP

Responsible Party: Cristália Produtos Químicos Farmacêuticos Ltda. Identifier: NCT01326078     History of Changes
Other Study ID Numbers: CRIST011
First Posted: March 30, 2011    Key Record Dates
Last Update Posted: March 26, 2014
Last Verified: March 2014

Keywords provided by Cristália Produtos Químicos Farmacêuticos Ltda.:
bone marrow biopsy

Additional relevant MeSH terms:
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General