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Dexmedetomidine and Propofol for Pediatric MRI Sedation

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ClinicalTrials.gov Identifier: NCT03513757
Recruitment Status : Recruiting
First Posted : May 2, 2018
Last Update Posted : May 3, 2018
Sponsor:
Information provided by (Responsible Party):
Susan Taylor, Medical College of Wisconsin

Brief 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 70 children between the ages of 12 and 72 months for the study and hope to have the study completed in December 2018.


Condition or disease Intervention/treatment Phase
Headache Tumor Seizure Disorder Neurofibromatoses Hydrocephalus Abdominal Neoplasm Spine Deformity Drug: propofol Drug: Dexmedetomidine Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
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.
Primary Purpose: Treatment
Official Title: An Observer-blinded Randomized Study of Propofol Infusion vs Bolus Dexmedetomidine and Propofol Sedation for Pediatric Magnetic Resonance Imaging
Actual Study Start Date : March 4, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018


Arm Intervention/treatment
Active Comparator: propofol
Each patient will receive 1 mg/kg lidocaine followed by 2 mg/kg propofol IV once prior to continuous propofol infusion for MRI sedation at 200 mic/kg/min. Dose will be increased by 50 mic/kg/min up to 300 mic/kg/min for movement and decreased to 150 mic/kg/min if no movement after 30 minutes. Additional 1 mg/kg propofol bolus administered at time of each movement. Study to be terminated if movement persists despite above interventions.
Drug: propofol
propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 200 mic/kg/minute propofol infusion if movement persists
Other Name: diprivan

Experimental: propofol dexmedetomidine
Each patient will receive: 1 mg/kg lidocaine, 2 mg/kg propofol, 4 mic/kg glycopyrrolate and single dose dexmedetomidine administered prior to scan. Dexmedetomidine dose is dependent on expected duration of scan and will be equal to 1 mic/kg/hour x duration of scan in hours. 1 mg/kg propofol will be administered for movement up to 2 times. For continued movement after that, begin propofol infusion at 150 mic/kg/min. Study to be terminated if movement persists despite above interventions.
Drug: propofol
propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 200 mic/kg/minute propofol infusion if movement persists
Other Name: diprivan

Drug: Dexmedetomidine
single dose dexmedetomidine administered at start of sedation. Dosing is based upon anticipated duration of scan from 30 - 75 minutes and will range from 0.5 mic/kg to 1.25 mic/kg
Other Name: precedex




Primary Outcome Measures :
  1. Efficiency of propofol dexmedetomidine sedation compared with propofol infusion [ Time Frame: through study completion, an average of 2 hours ]
    Efficiency is measured as time from start of anesthesia to readiness for discharge from the department to home or clinic.


Secondary Outcome Measures :
  1. total propofol administration [ Time Frame: up to 90 hour ]
    mg/kg

  2. dexmedetomidine dose [ Time Frame: up to 90 minutes ]
    mic/kg

  3. glycopyrrolate dose [ Time Frame: 5 minutes ]
    mic/kg

  4. lidocaine dose [ Time Frame: up to 90 minutes ]
    mg/kg

  5. nitrous oxide [ Time Frame: up to 10 minutes ]
    documentation of use

  6. sevoflurane [ Time Frame: up to 10 minutes ]
    5 minutes

  7. eye opening [ Time Frame: up to 90 minutes ]
    minutes from completion of scan to spontaneous eye opening

  8. oral/enteral intake [ Time Frame: up to 2 hours ]
    minutes from completion of scan to oral/enteral intake

  9. discharge ready [ Time Frame: up to 2 hours ]
    minutes from completion of scan to discharge ready

  10. sleep pattern [ Time Frame: up to 48 hours ]
    parental observation of deviation from child's normal habit obtained through follow-up phone call

  11. irritability [ Time Frame: up to 48 hours ]
    behavior deemed inappropriate and a deviation from child's normal though parental observation obtained through follow-up phone call

  12. delirium [ Time Frame: up to 24 hours. ]
    Pediatric Anesthesia Emergence Delirium (PAED) score greater than 12 as defined by Sikich and Lerman. 0 = no delirium, 20 = worst possible delirium; 5 categories scored from 0-4 additive for a maximum score of 20. Categories 1-3 are scored the same and categories ar scored inversely as described. 1. Child makes contact with caregiver, 2. child's actions are purposeful, 3. child is aware of his surroundings. For each of these category, score 0 for extremely, 1 for very much, 2 for quite a bit, 3 for just a little, 4 for not at all. The other 2 categories 4. Child is restless and 5 Child is inconsolable are scored as 0 for not at all, 1 for just a little, 2 for quite a bit, 3 for very much, 4 for extremely



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months to 60 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03513757


Contacts
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Contact: Susan P Taylor, MD, MPH 4142663560 sutaylor@mcw.edu
Contact: Amy Henry, MD 4142663560 ahenry@mcw.edu

Locations
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United States, Wisconsin
Children's Hospital of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Susan P Taylor, MD, MPH    414-266-3560    sutaylor@mcw.edu   
Contact: Amy Henry, MD    4142663560    ahenry@mcw.edu   
Sponsors and Collaborators
Medical College of Wisconsin
Investigators
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Principal Investigator: Susan P Taylor, MD, MPH Children's Hospital and Health System Foundation, Wisconsin

Publications:

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Responsible Party: Susan Taylor, Associate Professor, Department of Pediatric Anesthesiology, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT03513757     History of Changes
Other Study ID Numbers: CHW 959242-5
First Posted: May 2, 2018    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neurofibromatoses
Hypnotics and Sedatives
Abdominal Neoplasms
Seizures
Hydrocephalus
Epilepsy
Headache
Pain
Neurologic Manifestations
Signs and Symptoms
Nervous System Diseases
Neurofibroma
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplastic Syndromes, Hereditary
Neurocutaneous Syndromes
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Brain Diseases
Central Nervous System Diseases
Neoplasms by Site
Dexmedetomidine
Propofol
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General