Propofol and Tiopentone in paediatric sedation for fRMI study. - ND

Conditions: chirldren aged from 1 to 4 years old undergoing fMRI for convulsive crisis or delay in growth
MedDRA version: 12.0Level: LLTClassification code 10010914Term: Convulsions

Registration Number: EUCTR2009-013201-33-IT

Lead Sponsor: FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

-counter indication in using Propofol or Tipentone - presence of abnormalities to MRI -parents` refuse to sign informed consent

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures