Status:
TERMINATED
Two Anesthetic Techniques in Magnetic Resonance Imaging (MRI)
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Conditions:
Magnetic Resonance Imaging
Anesthesia
Eligibility:
All Genders
12-7 years
Phase:
PHASE1
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 bo...
Eligibility Criteria
Inclusion
- 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).
- 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.
- The subjects must be 12 months to 7 years (inclusive of the seventh year).
- The subject's legally authorized representative has given written informed consent to participate in the study.
Exclusion
- The subject is residing in the Pediatric Intensive Care Unit, the Cardiac Intensive Care Unit, or Neonatal Intensive Care Unit.
- Anxiolytic medication is ordered before the MRI (e.g., midazolam or ketamine).
- The subject has a history or a family (parent or sibling) history of malignant hyperthermia.
- 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).
- The subject is allergic to or has a contraindication to any of the drugs used in the study.
- The subject has previously been treated under this protocol.
- The subject has a tracheostomy or other mechanical airway device.
- 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).
- The subject is not scheduled to receive anesthesia-sedation care for the MRI.
- The subject received one of the anesthetic regimens for the same MRI during the past six months.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT00894751
Start Date
January 1 2009
End Date
December 1 2011
Last Update
September 21 2020
Active Locations (1)
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1
Cincinnati Children's Medical Center
Cincinnati, Ohio, United States, 45229