Dexmedetomidine and Propofol for Pediatric MRI Sedation
Condition: Headache; Tumor; Seizure Disorder; Neurofibromatoses; Hydrocephalus; Abdominal Neoplasm; Spine Deformity
MeSH terms: Neurofibromatoses; Abdominal Neoplasms; Seizures; Hydrocephalus; Epilepsy
Intervention: propofol; Dexmedetomidine; Glycopyrrolate; Lidocaine 1% Injectable Solution; Nitrous Oxide; Sevoflurane
Intervention description: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists; single dose dexmedetomidine administered at start of sedation in the propofol-dexmedetomidine group. Dosing is based upon anticipated duration of scan from 30 - 75 minutes and will range from 0.5 mic/kg to 1.25 mcg/kg; 4 mcg/kg glycopyrrolate will be administered at the start of sedation in the propofol-dexmedetomidine group; 1 mg/kg intravenous administration prior to propofol administration; Inhalation of nitrous oxide may be used for IV placement; Inhalation of sevoflurane may be used for IV placement
Intervention MeSH terms: Lidocaine; Glycopyrrolate; Dexmedetomidine; Nitrous Oxide; Propofol; Sevoflurane
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: observer blinded comparison of propofol with low-dose propofol and dexmedetomidine for pediatric MRI sedation
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: The patients and their parents/guardians as well as the blinded observer or investigator who participates in outcomes assessment will be blinded to the drug or drugs administered.
Enrollment: 40.0
Sex: All
Minimum age: 12 Months
Maximum age: 60 Months
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the results of combining two anesthetic medications
      (dexmedetomidine and propofol) in low doses with a standard dose of a single drug that is
      commonly used to provide sedation/anesthesia for MRI studies in young children (propofol).

      The drugs used for the MRI scan in this study will be chosen randomly. Half the patients will
      receive small doses of propofol and dexmedetomidine. The other half will receive propofol
      administered constantly throughout the scan. Other drugs that may be used include sevoflurane
      and nitrous oxide at the start of the sedation (for placing an intravenous), lidocaine (to
      reduce the pain of propofol injection) and glycopyrrolate (to prevent the heart rate from
      decreasing too low. The investigators will record 5 additional blood pressures and heart
      rates. If additional medications are required to complete the scan, the investigators will
      administer whatever is necessary. At the end of the study, the investigators will have an
      observer record the time it takes for participants to spontaneously open eyes , to be able to
      drink liquids and/or eat and to behave as before the study. Also, it is very important that
      the investigators find out from participants about changes in behavior, or if eating or
      sleeping habits were unusual following completion of the study. For that reason, the
      investigators will call participants in a day or so following the MRI scan.

      The investigators expect to recruit 40 children between the ages of 12 and 72 months for the
      study and hope to have the study completed in December 2018.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All children scheduled for outpatient MRI scans with expected duration of scan between
             30 minutes and 75 minutes.

        Exclusion Criteria:

          -  Inpatient status, airway abnormalities, allergy to any study medications, eggs and
             soy, and mitochondrial disorders.

          -  All subjects with any cardiac disease or history of cardiac arrhythmias will be
             excluded.