Two Anesthetic Techniques in Magnetic Resonance Imaging (MRI)

Stopped early · Phase 1

Conditions studied: Magnetic Resonance Imaging, Anesthesia

In brief

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).

Key facts

Study ID

NCT00894751

Run by

Children's Hospital Medical Center, Cincinnati

People needed

98

Starts

2009-01-01

Expected to finish

2011-12-01

Last updated by the study team

2020-09-21

Who can join

Age: 1 and older, up to 7. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Cincinnati Children's Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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