Optimal Dose of Propofol for Induction of Deep Sedation for Brain MRI Scanning in Children With Cerebral Palsy
1 other identifier
interventional
20
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2010
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 18, 2010
CompletedFirst Posted
Study publicly available on registry
November 19, 2010
CompletedNovember 19, 2010
November 1, 2010
4 months
November 18, 2010
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
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hae-Keum Kil, MD, Ph.D
Severance Hospital
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