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Dexmedetomidine and Propofol for Pediatric MRI Sedation

Sponsor
Medical College of Wisconsin (Other)
Overall Status
Completed
CT.gov ID
NCT03513757
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
7.6
Actual Duration (Months)
5.3
Patients Per Site Per Month

Study Details

Study Description

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 40 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
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.

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
observer blinded comparison of propofol with low-dose propofol and dexmedetomidine for pediatric MRI sedationobserver 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 :
Mar 4, 2018
Actual Primary Completion Date :
Aug 21, 2018
Actual Study Completion Date :
Oct 21, 2018

Arms and Interventions

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 mcg/kg/min. Dose will be increased by 50 mcg/kg/min up to 300 mcg/kg/min for movement and decreased to 150 mcg/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, 150-300 mcg/kg/minute propofol infusion if movement persists
Other Names:
  • diprivan

    • Drug: Lidocaine 1% Injectable Solution
    1 mg/kg intravenous administration prior to propofol administration
    Other Names:
  • Xylocaine 1%

    • Drug: Nitrous Oxide
    Inhalation of nitrous oxide may be used for IV placement

    Drug: Sevoflurane
    Inhalation of sevoflurane may be used for IV placement
    Other Names:
  • Ultane

    		•
    Experimental: propofol dexmedetomidine

    Each patient will receive: 1 mg/kg lidocaine, 2 mg/kg propofol, 4 mcg/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 mcg/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 mcg/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, 150-300 mcg/kg/minute propofol infusion if movement persists
    Other Names:
  • diprivan

    • Drug: Dexmedetomidine
    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
    Other Names:
  • precedex

    • Drug: Glycopyrrolate
    4 mcg/kg glycopyrrolate will be administered at the start of sedation in the propofol-dexmedetomidine group
    Other Names:
  • Robinul

    • Drug: Lidocaine 1% Injectable Solution
    1 mg/kg intravenous administration prior to propofol administration
    Other Names:
  • Xylocaine 1%

    • Drug: Nitrous Oxide
    Inhalation of nitrous oxide may be used for IV placement

    Drug: Sevoflurane
    Inhalation of sevoflurane may be used for IV placement
    Other Names:
  • Ultane

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Efficiency of Propofol Dexmedetomidine Sedation Compared With Propofol Infusion [through study completion, an average of 2 hours]

      Time (minutes) from anesthesia start to readiness for discharge from the department to home or clinic.

    Secondary Outcome Measures

    1. Total Propofol Administered [up to 90 minutes]

      total propofol administered (mg/kg)

    2. Dexmedetomidine Dose [up to 90 minutes]

      dexmedetomidine dose (mcg/kg)

    3. Glycopyrrolate Dose [5 minutes]

      glycopyrrolate dose (mcg/kg)

    4. Lidocaine Dose [up to 90 minutes]

      lidocaine dose (mg/kg)

    5. Nitrous Oxide [up to 10 minutes]

      documentation of use

    6. Sevoflurane [sevoflurane induction time up to 10 minutes]

      sevoflurane induction time of 5 minutes

    7. Eye Opening [up to 90 minutes]

      minutes from completion of scan to spontaneous eye opening

    8. Oral/Enteral Intake [up to 2 hours]

      minutes from completion of scan to oral/enteral intake

    9. Discharge Ready [up to 2 hours]

      minutes from completion of scan to discharge ready

    10. Sleep Pattern [up to 48 hours]

      parental observation of deviation from child's normal habit obtained through follow-up phone call

    11. Irritability [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 [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

    Eligibility Criteria

    Criteria

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Children's Hospital of Wisconsin Milwaukee Wisconsin United States 53226

    Sponsors and Collaborators

    • Medical College of Wisconsin

    Investigators

    • Principal Investigator: Susan P Taylor, MD, MPH, Children's Hospital and Health System Foundation, Wisconsin

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Susan Taylor, Associate Professor, Department of Pediatric Anesthesiology, Medical College of Wisconsin
    ClinicalTrials.gov Identifier:
    NCT03513757
    Other Study ID Numbers:
    • CHW 959242-5
    First Posted:
    May 2, 2018
    Last Update Posted:
    Feb 21, 2020
    Last Verified:
    Feb 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neurofibromatoses
    Abdominal Neoplasms
    Seizures
    Hydrocephalus
    Epilepsy
    Headache
    Lidocaine
    Glycopyrrolate
    Dexmedetomidine
    Nitrous Oxide
    Propofol
    Sevoflurane

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Propofol Propofol Dexmedetomidine
    Arm/Group Description 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 mcg/kg/min. Dose will be increased by 50 mcg/kg/min up to 300 mcg/kg/min for movement and decreased to 150 mcg/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. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 200 mic/kg/minute propofol infusion if movement persists Each patient will receive: 1 mg/kg lidocaine, 2 mg/kg propofol, 4 mcg/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 mcg/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 mcg/kg/min. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 200 mic/kg/minute propofol infusion if movement persists 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
    Period Title: Overall Study
    STARTED 22 18
    COMPLETED 22 18
    NOT COMPLETED 0 0

    Baseline Characteristics

    Arm/Group Title Propofol Propofol Dexmedetomidine Total
    Arm/Group Description 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. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 200 mic/kg/minute propofol infusion if movement persists 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. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 200 mic/kg/minute propofol infusion if movement persists 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 Total of all reporting groups
    Overall Participants 22 18 40
    Age (months) [Median (Inter-Quartile Range) ]
    Median (Inter-Quartile Range) [months]
    39
    26
    34
    Sex: Female, Male (Count of Participants)
    Female
    9
    40.9%
    7
    38.9%
    16
    40%
    Male
    13
    59.1%
    11
    61.1%
    24
    60%
    Race and Ethnicity Not Collected (Count of Participants)
    Count of Participants [Participants]
    0
    0%
    Region of Enrollment (Count of Participants)
    United States
    22
    100%
    18
    100%
    40
    100%

    Outcome Measures

    1. Primary Outcome
    Title Efficiency of Propofol Dexmedetomidine Sedation Compared With Propofol Infusion
    Description Time (minutes) from anesthesia start to readiness for discharge from the department to home or clinic.
    Time Frame through study completion, an average of 2 hours

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Propofol Propofol Dexmedetomidine
    Arm/Group Description 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 mcg/kg/min. Dose will be increased by 50 mcg/kg/min up to 300 mic/kg/min for movement and decreased to 150 mcg/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. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists Each patient will receive: 1 mg/kg lidocaine, 2 mg/kg propofol, 4 mcg/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 mcg/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 mcg/kg/min. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists. Dexmedetomidine: 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. Glycopyrrolate: 4 mcg/kg glycopyrrolate will be administered at the start of sedation in the propofol-dexmedetomidine group.
    Measure Participants 22 18
    Median (Inter-Quartile Range) [minutes]
    98
    77
    2. Secondary Outcome
    Title Total Propofol Administered
    Description total propofol administered (mg/kg)
    Time Frame up to 90 minutes

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Propofol Propofol Dexmedetomidine
    Arm/Group Description 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 mcg/kg/min. Dose will be increased by 50 mcg/kg/min up to 300 mcg/kg/min for movement and decreased to 150 mcg/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. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 200 mcg/kg/minute propofol infusion if movement persists Each patient will receive: 1 mg/kg lidocaine, 2 mg/kg propofol, 4 mcg/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 mcg/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 mcg/kg/min. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists. Dexmedetomidine: 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. Glycopyrrolate: 4 mcg/kg glycopyrrolate will be administered at the start of sedation in the propofol-dexmedetomidine group.
    Measure Participants 22 18
    Median (Inter-Quartile Range) [mg/kg]
    10.6
    3.0
    3. Secondary Outcome
    Title Dexmedetomidine Dose
    Description dexmedetomidine dose (mcg/kg)
    Time Frame up to 90 minutes

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Propofol Propofol Dexmedetomidine
    Arm/Group Description 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 mcg/kg/min. Dose will be increased by 50 mcg/kg/min up to 300 mcg/kg/min for movement and decreased to 150 mcg/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. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 200 mcg/kg/minute propofol infusion if movement persists. Each patient will receive: 1 mg/kg lidocaine, 2 mg/kg propofol, 4 mcg/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 mcg/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 mcg/kg/min. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists. Dexmedetomidine: 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. Glycopyrrolate: 4 mcg/kg glycopyrrolate will be administered at the start of sedation in the propofol-dexmedetomidine group.
    Measure Participants 22 18
    Median (Inter-Quartile Range) [mcg/kg]
    0
    0.70
    4. Secondary Outcome
    Title Glycopyrrolate Dose
    Description glycopyrrolate dose (mcg/kg)
    Time Frame 5 minutes

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Propofol Propofol Dexmedetomidine
    Arm/Group Description 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 mcg/kg/min. Dose will be increased by 50 mcg/kg/min up to 300 mcg/kg/min for movement and decreased to 150 mcg/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. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 200 mcg/kg/minute propofol infusion if movement persists. Each patient will receive: 1 mg/kg lidocaine, 2 mg/kg propofol, 4 mcg/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 mcg/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 mcg/kg/min. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists. Dexmedetomidine: 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. Glycopyrrolate: 4 mcg/kg glycopyrrolate will be administered at the start of sedation in the propofol-dexmedetomidine group.
    Measure Participants 22 18
    Median (Inter-Quartile Range) [mcg/kg]
    0
    4.2
    5. Secondary Outcome
    Title Lidocaine Dose
    Description lidocaine dose (mg/kg)
    Time Frame up to 90 minutes

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Propofol Propofol Dexmedetomidine
    Arm/Group Description 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 mcg/kg/min. Dose will be increased by 50 mcg/kg/min up to 300 mcg/kg/min for movement and decreased to 150 mcg/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. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 200 mcg/kg/minute propofol infusion if movement persists. Each patient will receive: 1 mg/kg lidocaine, 2 mg/kg propofol, 4 mcg/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 mcg/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 mcg/kg/min. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists. Dexmedetomidine: 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. Glycopyrrolate: 4 mcg/kg glycopyrrolate will be administered at the start of sedation in the propofol-dexmedetomidine group.
    Measure Participants 22 18
    Median (Inter-Quartile Range) [mg/kg]
    1.00
    1.00
    6. Secondary Outcome
    Title Nitrous Oxide
    Description documentation of use
    Time Frame up to 10 minutes

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Propofol Propofol Dexmedetomidine
    Arm/Group Description 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 mcg/kg/min. Dose will be increased by 50 mcg/kg/min up to 300 mcg/kg/min for movement and decreased to 150 mcg/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. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 200 mcg/kg/minute propofol infusion if movement persists. Each patient will receive: 1 mg/kg lidocaine, 2 mg/kg propofol, 4 mcg/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 mcg/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 mcg/kg/min. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists. Dexmedetomidine: 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. Glycopyrrolate: 4 mcg/kg glycopyrrolate will be administered at the start of sedation in the propofol-dexmedetomidine group.
    Measure Participants 22 18
    Number [participants]
    18
    81.8%
    17
    94.4%
    7. Secondary Outcome
    Title Sevoflurane
    Description sevoflurane induction time of 5 minutes
    Time Frame sevoflurane induction time up to 10 minutes

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Propofol Propofol Dexmedetomidine
    Arm/Group Description 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 mcg/kg/min. Dose will be increased by 50 mcg/kg/min up to 300 mcg/kg/min for movement and decreased to 150 mcg/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. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 200 mcg/kg/minute propofol infusion if movement persists. Each patient will receive: 1 mg/kg lidocaine, 2 mg/kg propofol, 4 mcg/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 mcg/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 mcg/kg/min. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists. Dexmedetomidine: 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. Glycopyrrolate: 4 mcg/kg glycopyrrolate will be administered at the start of sedation in the propofol-dexmedetomidine group.
    Measure Participants 22 18
    Number [participants]
    18
    81.8%
    17
    94.4%
    8. Secondary Outcome
    Title Eye Opening
    Description minutes from completion of scan to spontaneous eye opening
    Time Frame up to 90 minutes

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Propofol Propofol Dexmedetomidine
    Arm/Group Description 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 mcg/kg/min. Dose will be increased by 50 mcg/kg/min up to 300 mcg/kg/min for movement and decreased to 150 mcg/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. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 200 mcg/kg/minute propofol infusion if movement persists. Each patient will receive: 1 mg/kg lidocaine, 2 mg/kg propofol, 4 mcg/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 mcg/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 mcg/kg/min. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists. Dexmedetomidine: 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. Glycopyrrolate: 4 mcg/kg glycopyrrolate will be administered at the start of sedation in the propofol-dexmedetomidine group.
    Measure Participants 22 18
    Median (Inter-Quartile Range) [minutes]
    28
    3
    9. Secondary Outcome
    Title Oral/Enteral Intake
    Description minutes from completion of scan to oral/enteral intake
    Time Frame up to 2 hours

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Propofol Propofol Dexmedetomidine
    Arm/Group Description 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 mcg/kg/min. Dose will be increased by 50 mcg/kg/min up to 300 mcg/kg/min for movement and decreased to 150 mcg/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. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 200 mcg/kg/minute propofol infusion if movement persists. Each patient will receive: 1 mg/kg lidocaine, 2 mg/kg propofol, 4 mcg/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 mcg/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 mcg/kg/min. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists. Dexmedetomidine: 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. Glycopyrrolate: 4 mcg/kg glycopyrrolate will be administered at the start of sedation in the propofol-dexmedetomidine group.
    Measure Participants 22 18
    Median (Inter-Quartile Range) [minutes]
    33
    14
    10. Secondary Outcome
    Title Discharge Ready
    Description minutes from completion of scan to discharge ready
    Time Frame up to 2 hours

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Propofol Propofol Dexmedetomidine
    Arm/Group Description 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 mcg/kg/min. Dose will be increased by 50 mcg/kg/min up to 300 mcg/kg/min for movement and decreased to 150 mcg/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. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 200 mcg/kg/minute propofol infusion if movement persists. Each patient will receive: 1 mg/kg lidocaine, 2 mg/kg propofol, 4 mcg/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 mcg/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 mcg/kg/min. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists. Dexmedetomidine: 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. Glycopyrrolate: 4 mcg/kg glycopyrrolate will be administered at the start of sedation in the propofol-dexmedetomidine group.
    Measure Participants 22 18
    Median (Inter-Quartile Range) [minutes]
    40
    17
    11. Secondary Outcome
    Title Sleep Pattern
    Description parental observation of deviation from child's normal habit obtained through follow-up phone call
    Time Frame up to 48 hours

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Propofol Propofol Dexmedetomidine
    Arm/Group Description 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 mcg/kg/min. Dose will be increased by 50 mcg/kg/min up to 300 mcg/kg/min for movement and decreased to 150 mcg/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. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 200 mcg/kg/minute propofol infusion if movement persists. Each patient will receive: 1 mg/kg lidocaine, 2 mg/kg propofol, 4 mcg/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 mcg/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 mcg/kg/min. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists. Dexmedetomidine: 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. Glycopyrrolate: 4 mcg/kg glycopyrrolate will be administered at the start of sedation in the propofol-dexmedetomidine group.
    Measure Participants 22 18
    Number [participants]
    3
    13.6%
    2
    11.1%
    12. Secondary Outcome
    Title Irritability
    Description behavior deemed inappropriate and a deviation from child's normal though parental observation obtained through follow-up phone call
    Time Frame up to 48 hours

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Propofol Propofol Dexmedetomidine
    Arm/Group Description 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 mcg/kg/min. Dose will be increased by 50 mcg/kg/min up to 300 mcg/kg/min for movement and decreased to 150 mcg/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. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 200 mcg/kg/minute propofol infusion if movement persists. Each patient will receive: 1 mg/kg lidocaine, 2 mg/kg propofol, 4 mcg/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 mcg/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 mcg/kg/min. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists. Dexmedetomidine: 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 mcg/kg to 1.25 mcg/kg. Glycopyrrolate: 4 mcg/kg glycopyrrolate will be administered at the start of sedation in the propofol-dexmedetomidine group.
    Measure Participants 22 18
    Number [participants]
    3
    13.6%
    0
    0%
    13. Secondary Outcome
    Title Delirium
    Description 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
    Time Frame up to 24 hours.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Propofol Propofol Dexmedetomidine
    Arm/Group Description 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 mcg/kg/min. Dose will be increased by 50 mcg/kg/min up to 300 mcg/kg/min for movement and decreased to 150 mcg/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. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 200 mcg/kg/minute propofol infusion if movement persists. Each patient will receive: 1 mg/kg lidocaine, 2 mg/kg propofol, 4 mcg/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 mcg/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 mcg/kg/min. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists. Dexmedetomidine: 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 mcg/kg to 1.25 mcg/kg. Glycopyrrolate: 4 mcg/kg glycopyrrolate will be administered at the start of sedation in the propofol-dexmedetomidine group.
    Measure Participants 22 18
    Number [participants]
    0
    0%
    0
    0%

    Adverse Events

    Time Frame 48 hours
    Adverse Event Reporting Description
    Arm/Group Title Propofol Propofol Dexmedetomidine
    Arm/Group Description 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 mcg/kg/min. Dose will be increased by 50 mcg/kg/min up to 300 mcg/kg/min for movement and decreased to 150 mcg/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. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 200 mic/kg/minute propofol infusion if movement persists Each patient will receive: 1 mg/kg lidocaine, 2 mg/kg propofol, 4 mcg/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 mcg/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 mcg/kg/min. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 200 mic/kg/minute propofol infusion if movement persists 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
    All Cause Mortality
    Propofol Propofol Dexmedetomidine
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/22 (0%) 0/18 (0%)
    Serious Adverse Events
    Propofol Propofol Dexmedetomidine
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/22 (0%) 0/18 (0%)
    Other (Not Including Serious) Adverse Events
    Propofol Propofol Dexmedetomidine
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 13/22 (59.1%) 10/18 (55.6%)
    Injury, poisoning and procedural complications
    respiratory events during induction/anesthesia/recovery 10/22 (45.5%) 10 8/18 (44.4%) 8
    movement 3/22 (13.6%) 3 2/18 (11.1%) 4

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Susan Taylor MD
    Organization Medical College of Wisconsin
    Phone 414-266-3560
    Email sutaylor@mcw.edu
    Responsible Party:
    Susan Taylor, Associate Professor, Department of Pediatric Anesthesiology, Medical College of Wisconsin
    ClinicalTrials.gov Identifier:
    NCT03513757
    Other Study ID Numbers:
    • CHW 959242-5
    First Posted:
    May 2, 2018
    Last Update Posted:
    Feb 21, 2020
    Last Verified:
    Feb 1, 2020