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

This study has been completed.
Sponsor:
Information provided by:
Yonsei University
ClinicalTrials.gov Identifier:
NCT01244113
First received: November 18, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Cerebral Palsy
 Drug: propofol

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Optimal Dose of Propofol for Induction of Deep Sedation for Brain MRI Scanning in Children With Cerebral Palsy

Resource links provided by NLM:

Drug Information available for: Propofol
U.S. FDA Resources

Further study details as provided by Yonsei University:

Enrollment: 20
Study Start Date: July 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: 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
  Eligibility

Ages Eligible for Study:   6 Months to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • children with cerebral palsy with patient agreement

Exclusion Criteria:

  • sleep apnea, difficult airway, cardiorespiratory disease, allergic history to propofol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01244113

Locations
Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
Investigators
Principal Investigator: Hae-Keum Kil, MD, Ph.D Severance Hospital
  More Information

No publications provided

Responsible Party: Hae-Keum Kil / Proffesor, Severance Hospital, Department of Anaesthesiology and Pain Medicine
ClinicalTrials.gov Identifier: NCT01244113     History of Changes
Other Study ID Numbers: 4-2010-0150
Study First Received: November 18, 2010
Last Updated: November 18, 2010
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Cerebral Palsy
Paralysis
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Propofol
 Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on May 23, 2013