Two Anesthetic Techniques in Magnetic Resonance Imaging (MRI)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-12-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Magnetic Resonance Imaging Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

dexmedetomidine

Intervention Type DRUG

dexmedetomidine general anesthesia for MRI

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.

Group Type ACTIVE_COMPARATOR

propofol

Intervention Type DRUG

propofol general anesthesia for MRI

Interventions

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dexmedetomidine

dexmedetomidine general anesthesia for MRI

Intervention Type DRUG

propofol

propofol general anesthesia for MRI

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

12 Months

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes