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Two Anesthetic Techniques in Magnetic Resonance Imaging (MRI)

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.
 
ClinicalTrials.gov Identifier: NCT00894751
Recruitment Status : Terminated (low enrollment and high participant withdraw)
First Posted : May 7, 2009
Last Update Posted : September 21, 2020
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Brief Summary:
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 or disease Intervention/treatment Phase
Magnetic Resonance Imaging Anesthesia Drug: dexmedetomidine Drug: propofol Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Qualitative Comparison of Two Anesthetic Techniques in Children Undergoing Magnetic Resonance Imaging
Actual Study Start Date : January 2009
Actual Primary Completion Date : January 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. The primary outcome variable will be the time spent in the MRI room [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Secondary outcome variables include incidence-severity of respiratory complications [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months to 7 Years   (Child)
Sexes Eligible for Study:   All
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.

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): NCT00894751


Locations
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United States, Ohio
Cincinnati Children's Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT00894751    
Other Study ID Numbers: 2008-0281
First Posted: May 7, 2009    Key Record Dates
Last Update Posted: September 21, 2020
Last Verified: August 2020
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:
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Dexmedetomidine
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action