Two Anesthetic Techniques in Magnetic Resonance Imaging (MRI)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Children's Hospital Medical Center, Cincinnati.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT00894751
First received: May 6, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted

May 6, 2009
May 6, 2009
January 2009
January 2011   (final data collection date for primary outcome measure)
The primary outcome variable will be the time spent in the MRI room [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Secondary outcome variables include incidence-severity of respiratory complications [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Two Anesthetic Techniques in Magnetic Resonance Imaging (MRI)
A Qualitative Comparison of Two Anesthetic Techniques in Children Undergoing Magnetic Resonance Imaging

The goal of this study is to determine if there is a significant difference in the quality of care between the investigators' two standard anesthesia techniques for children undergoing a MRI of the body and/or extremity MRI. Quality of care will be measured by time spent in the MRI room as well as parental satisfaction, frequency of interruptions of the MRI scan, incidence-severity of respiratory complications, post anesthesia agitation, and time spent in the induction room, MRI room, and Post-Anesthesia Care Unit (PACU).

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
  • Magnetic Resonance Imaging
  • Anesthesia
  • Drug: dexmedetomidine
    dexmedetomidine general anesthesia for MRI
  • Drug: propofol
    propofol general anesthesia for MRI
  • Active Comparator: dexmedetomidine
    Determine if there is a significant difference in the quality of care between our two standard anesthesia techniques for children undergoing a MRI of the body and/or extremity MRI.
    Intervention: Drug: dexmedetomidine
  • Active Comparator: propofol
    Determine if there is a significant difference in the quality of care between our two standard anesthesia techniques for children undergoing a MRI of the body and/or extremity MRI.
    Intervention: Drug: propofol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
160
Not Provided
January 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Subjects presenting as out-patients, scheduled to receive an anesthetic for MRI of body (spine, chest, abdomen, and/or pelvis) and/or extremity (arm and/or leg).
  2. The subject must be a candidate for both anesthetic techniques. This decision will be made by a staff member of the Department of Anesthesiology. This staff member will not be a member of the study team and will obtain the consent for Anesthesia.
  3. The subjects must be 12 months to 7 years (inclusive of the seventh year).
  4. The subject's legally authorized representative has given written informed consent to participate in the study.

Exclusion Criteria:

  1. The subject is residing in the Pediatric Intensive Care Unit, the Cardiac Intensive Care Unit, or Neonatal Intensive Care Unit.
  2. Anxiolytic medication is ordered before the MRI (e.g., midazolam or ketamine).
  3. The subject has a history or a family (parent or sibling) history of malignant hyperthermia.
  4. The subject has life-threatening, medical conditions (American Society of Anesthesiologists Physical Status 4, 5 or 6).

    • The American Society of Anesthesiologists (ASA) classification scale is a measure of physical status or how healthy the patient is.
    • For our study, we will focus on children which are defined as ASA I, II or III which means a healthy child (ASA I), a child with a systemic disease that is mild and well controlled (ASA II) or a child with systemic disease that is severe and controlled (ASA III).
  5. The subject is allergic to or has a contraindication to any of the drugs used in the study.
  6. The subject has previously been treated under this protocol.
  7. The subject has a tracheostomy or other mechanical airway device.
  8. The subject has received within the past 12 hours an oral or intravenous alpha-adrenergic, beta-adrenergic agonist, or antagonist drugs (e.g., clonidine, propranolol, albuterol).
  9. The subject is not scheduled to receive anesthesia-sedation care for the MRI.
  10. The subject received one of the anesthetic regimens for the same MRI during the past six months.
Both
12 Months to 7 Years
Yes
Contact: JUNZHENG WU, MD 5132523489 junzheng.wu@cchmc.org
United States
 
NCT00894751
2008-0281
Yes
Mohamed Mahmoud, Children's Hospital Medical Center, Cincinnati
Children's Hospital Medical Center, Cincinnati
Not Provided
Not Provided
Children's Hospital Medical Center, Cincinnati
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP