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Optimal Dose of Propofol for Induction of Deep Sedation for Brain MRI Scanning in Children With Cerebral Palsy

NCT ID: NCT01244113

Last Updated: 2010-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2010-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cerebral Palsy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Interventions

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propofol

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* children with cerebral palsy with patient agreement

Exclusion Criteria

* sleep apnea, difficult airway, cardiorespiratory disease, allergic history to propofol
Minimum Eligible Age

6 Months

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Severance Hospital, Department of Anaesthesiology and Pain Medicine

Principal Investigators

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Hae-Keum Kil, MD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital

Locations

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Severance Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2010-0150

Identifier Type: -

Identifier Source: org_study_id