We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01244113
First Posted: November 19, 2010
Last Update Posted: November 19, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Yonsei University
  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: None (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:


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: November 18, 2010
First Posted: November 19, 2010
Last Update Posted: November 19, 2010
Last Verified: November 2010

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