Two Anesthetic Techniques in Magnetic Resonance Imaging (MRI)

A Qualitative Comparison of Two Anesthetic Techniques in Children Undergoing Magnetic Resonance Imaging

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).

Study Overview

• Status: Terminated
• Conditions: Magnetic Resonance Imaging; Anesthesia
• Intervention / Treatment: Drug: dexmedetomidine; Drug: propofol

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 7 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary outcome variable will be the time spent in the MRI room	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Secondary outcome variables include incidence-severity of respiratory complications	2 years

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2009
• Primary Completion (ACTUAL): January 1, 2011
• Study Completion (ACTUAL): December 1, 2011

Study Registration Dates

• First Submitted: May 6, 2009
• First Submitted That Met QC Criteria: May 6, 2009
• First Posted (ESTIMATE): May 7, 2009

Study Record Updates

• Last Update Posted (ACTUAL): September 21, 2020
• Last Update Submitted That Met QC Criteria: September 17, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: dexmedetomidine and propofol for MRI; quality of care between two anesthetic agents for MRI
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Propofol; Dexmedetomidine
• Other Study ID Numbers: 2008-0281