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

Sponsor:

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

History of Changes

Tracking Information

First Received Date ^ICMJE

March 28, 2011

Last Updated Date

March 29, 2011

Start Date ^ICMJE

June 2011

Estimated Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01326078 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Nanoemulsion and Lipid Emulsion of Propofol in a Non-invasive Ambulatory Procedures Children

Official Title ^ICMJE

Comparison of Nanoemulsion of Propofol and Lipid Emulsion of Propofol in a Non-invasive Ambulatory Procedures Children

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.

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 ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care

Condition ^ICMJE

Leukemia
Bone Marrow Biopsy

Intervention ^ICMJE

Drug: propofol

3 - 4 mg/kg IV, adjustment dose if necessary

Study Arm (s)

Experimental: propofol nanoemulsion
3-4 mg/kg of propofol nanoemulsion will be administered by 1mL per 5 seconds, adjustment dose can be given.

Intervention: Drug: propofol
Active Comparator: propofol lipid emulsion
3-4 mg/kg will be administered by 1 ml per 5 seconds.

Intervention: Drug: propofol

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2011

Estimated Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

6 Years to 12 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Luciana C Lima, PhD		lulima1@hotmail.com
Contact: Hugo Praxedes		hugo@cristalia.com.br

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT01326078

Other Study ID Numbers ^ICMJE

CRIST011

Has Data Monitoring Committee

Responsible Party

Hugo Praxedes, Cristália Produtos Químicos Farmacêuticos Ltda

Study Sponsor ^ICMJE

Cristália Produtos Químicos Farmacêuticos Ltda.

Collaborators ^ICMJE

Instituto de Medicina Integral Professor Fernando Figueira - IMIP

Investigators ^ICMJE

Principal Investigator:

Luciana C Lima, PhD

IMIP

Information Provided By

Cristália Produtos Químicos Farmacêuticos Ltda.

Verification Date

March 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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