chirldren aged from 1 to 4 years old undergoing fMRI for convulsive crisis or delay in growth MedDRA version: 12.0 Level: LLT Classification code 10010914 Term: Convulsions
Conditions
Interventions
Trade Name: PROPOFOL B.BRAUN 1%
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Propofol
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration numb
Sponsors
FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -children aged from 1 to 4 years hold, hospitalized or in day hospital in our Institute, for which is required MRI for convulsion or for growth retardation and for which the parents gave written informed consent. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -counter indication in using Propofol or Tipentone - presence of abnormalities to MRI -parents` refuse to sign informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to compare the 2 drugs commonly used for sedation in this age group (propofol and Tiopentone) to identify the drug with the minor impact on cortical activation pointed out bu fRMI.;Secondary Objective: to compare the 2 drugs commonly used for sedation in this age group (propofol and Tiopentone) to identify the drug with the minor impact on cortical activation pointed out bu fRMI.;Primary end point(s): to compare the 2 drugs commonly used for sedation in this age group (propofol and Tiopentone) to identify the drug with the minor impact on cortical activation pointed out bu fRMI. | — |
Countries
Italy
Outcome results
None listed