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
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      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).

      Recent studies and the FDA have raised concerns that anesthesia for longer than three hours
      may have effects on behavior and learning. Although investigators do not know if these
      effects are caused by drugs or the medical condition a child is being treated for, in
      December 2016, the FDA published the information below regarding anesthesia for children:

      General anesthetic and sedation drugs are used to put people into a deep sleep so they do not
      feel pain during surgery or procedures.

      These drugs are usually injected into a vein or breathed in through a mask. General
      anesthetic and sedation drugs are widely used to ensure the health, safety, and comfort of
      children and adults undergoing surgery or other procedures.

      Recent studies in children suggest that a single, relatively short exposure to general
      anesthetic and sedation drugs in infants or toddlers is unlikely to have negative effects on
      behavior or learning. More research is still needed to fully understand how anesthetics might
      affect brain development, especially longer or repeated exposures and in more vulnerable
      children. Anesthetic and sedation drugs are necessary for infants, children, and pregnant
      women who require surgery or other painful and stressful procedures.
      https://www.fda.gov/Drugs/DrugSafety/ucm532356.htm Research in neonatal and infant animals
      has demonstrated that sedative and anesthetic agents, like propofol, produce adverse effects
      on brain development, including loss of brain cells resulting in long-term, possibly
      permanent changes in learning and behavior. These adverse effects appear to occur mostly
      after prolonged periods of sedation or anesthesia (generally greater than 3 hours) and when
      brain development is occurring at a rapid rate (which roughly occurs in children under 3
      years of age). It is not known if similar adverse effects occur in humans. Study participants
      should be advised that the drugs used to accomplish the procedure may have the potential to
      increase the loss of nerve cells in the developing brain of young child and that the clinical
      significance of any such changes is not known. There are some animal studies that suggests
      dexmedetomidine may be better for a growing infant's brain. However, the effects of
      dexmedetomidine alone or in combination with propofol on the developing brain have not been
      thoroughly tested to date." 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. Investigators will record
      5 additional blood pressures and heart rates. If additional medications are required to
      complete the scan, investigators will administer whatever is necessary. At the end of the
      study, an observer will record the time it takes for spontaneous eye opening, to be able to
      drink liquids and/or eat and to behave as before the study. Also, it is very important that
      investigators learn in the following day or two how the participant behaved at home; whether
      eating, behavior and sleeping were unusual. For that reason, the investigator will call the
      participant a day or so following the MRI scan.

      The investigators expect to recruit 70 children between the ages of 12 and 72 months for the
      study and hope to have the study completed in 2018.
    

Intervention name(s): propofol; Dexmedetomidine; Glycopyrrolate; Lidocaine 1% Injectable Solution; Nitrous Oxide; Sevoflurane
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 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
Other intervention name(s): diprivan; precedex; Robinul; Xylocaine 1%; Ultane
Intervention MeSH terms: Lidocaine; Glycopyrrolate; Dexmedetomidine; Nitrous Oxide; Propofol; Sevoflurane
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)
Primary purpose: Treatment