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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
  Purpose

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).


Condition Intervention Phase
Magnetic Resonance Imaging
Anesthesia
Drug: dexmedetomidine
Drug: propofol
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Qualitative Comparison of Two Anesthetic Techniques in Children Undergoing Magnetic Resonance Imaging

Resource links provided by NLM:


Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • The primary outcome variable will be the time spent in the MRI room [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Secondary outcome variables include incidence-severity of respiratory complications [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 160
Study Start Date: January 2009
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: dexmedetomidine
dexmedetomidine general anesthesia for MRI
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.
Drug: propofol
propofol general anesthesia for MRI

  Eligibility

Ages Eligible for Study:   12 Months to 7 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00894751

Contacts
Contact: JUNZHENG WU, MD 5132523489 junzheng.wu@cchmc.org

Locations
United States, Ohio
Cincinnati Children's Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: junzheng wu, MD    513-636-4408    junzheng.wu@cchmc.org   
Principal Investigator: Junzheng wu, MD         
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
  More Information

No publications provided

Responsible Party: Mohamed Mahmoud, Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT00894751     History of Changes
Other Study ID Numbers: 2008-0281
Study First Received: May 6, 2009
Last Updated: May 6, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Hospital Medical Center, Cincinnati:
dexmedetomidine and propofol for MRI
quality of care between two anesthetic agents for MRI

Additional relevant MeSH terms:
Anesthetics
Dexmedetomidine
Propofol
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Analgesics
Analgesics, Non-Narcotic
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014