NCT01244113

Brief Summary

The children with CP has been shown different drug responses from the normal population of children and it may related with a various oral medications such as baclofen, tizanidine, diazepam, dantrolene, or anticonvulsant drugs. The aim of this study is to establish the optimal induction dose of propofol for deep sedation to start MRI for \< 30 min in children with CP.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 19, 2010

Completed
Last Updated

November 19, 2010

Status Verified

November 1, 2010

Enrollment Period

4 months

First QC Date

November 18, 2010

Last Update Submit

November 18, 2010

Conditions

Interventions

optimization of propofol dose from 1.5 mg/kg to 2.5 mg/kg using Dixon's up and down method during MRI scanning

Eligibility Criteria

Age6 Months - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • children with cerebral palsy with patient agreement

You may not qualify if:

  • sleep apnea, difficult airway, cardiorespiratory disease, allergic history to propofol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Propofol

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Hae-Keum Kil, MD, Ph.D

    Severance Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 18, 2010

First Posted

November 19, 2010

Study Start

July 1, 2010

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

November 19, 2010

Record last verified: 2010-11

Locations