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A Pilot Study of Dexmedetomidine-Propofol in Children Undergoing Magnetic Resonance Imaging

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ClinicalTrials.gov Identifier: NCT02633241
Recruitment Status : Active, not recruiting
First Posted : December 17, 2015
Last Update Posted : April 26, 2018
Sponsor:
Information provided by (Responsible Party):
Joseph P. Cravero, Boston Children’s Hospital

Brief Summary:
This is a pilot study to determine if a standard bolus dose and infusion of dexmedetomidine can significantly decrease the dose of propofol (infusion) required for accomplishing an MRI.

Condition or disease Intervention/treatment Phase
Epilepsy Cerebral Palsy Developmental Delay Drug: Dexmedetomidine-Propofol Phase 4

Detailed Description:

A recent publication in the New England Journal of Medicine highlighted the accumulating evidence for neurotoxic effects of anesthetics in animal models and a collection of epidemiologic studies in humans. Recent studies of anesthesia in fetal and neonatal primates are yielding more evidence of neurotoxicity associated with many common anesthesia and sedation techniques (e.g. propofol, etomidate, sevoflurane, desflurane and isoflurane). On the other hand, the data suggests that some alternative sedative agents, such as Dexmedetomidine, may not have the same neurotoxic effect.

Children routinely undergo sedation for MRI scanning with large doses of propofol and other sedatives. Many of these scans occur at young ages when these children may be at risk of neurological injury from sedative exposure. In addition, these scans do not involve any stimulation - which could be protective against neurodegeneration.

The investigators propose a pilot study to determine if a standard bolus dose and infusion of dexmedetomidine can significantly decrease the dose of propofol (infusion) required for accomplishing an MRI. Based on previous work with the combination of propofol with dexmedetomidine for other procedures, we propose a standard dose of dexmedetomidine (1 mcg/kg bolus followed by an infusion at 1mcg/kg/hour). The investigators will augment this sedation with propofol (1mg/kg followed by 100mcg/kg/min infusion).

The investigators hypothesize that the use of low dose propofol with dexmedetomidine will be effective undergoing MRI while sparing exposure to the high dose of the sedative.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Pilot Study of Dexmedetomidine-Propofol in Children Undergoing Magnetic Resonance Imaging
Actual Study Start Date : March 2, 2017
Actual Primary Completion Date : January 20, 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

Arm Intervention/treatment
Dexmedetomidine-Propofol arm
Patients in this cohort will receive a combination of Dexmedetomidine 1mcg/kg and Propofol100mcg/kg/minute to accomplish an MRI examination.
Drug: Dexmedetomidine-Propofol
First, the investigators will administer dexmedetomidine 1mcg/kg over 5 minutes. Next, the investigators will begin an infusion at 1mcg/kg/hour. At the 5 minute point, propofol will be given (2mg/kg bolus followed by 100mcg/kg/min infusion). The attending clinician will determine whether or not the child is in an adequate state to begin the MRI scan. If the sedative effect of the dexmedetomidine-propofol does not produce a sufficiently sedated state within 10 minutes, a repeat bolus of propofol 2mg/kg will be administered. The dose of Dexmedetomidine will not be changed. The dose will be repeated if the child is not adequately sedated in 2 more minutes. At this time infusion rate of propofol will be increased to 200 mcg/kg/minute. If the child is not sedated in 5 more minutes, the outcome will be recorded as a technique failure and sedation will continue at the discretion of the anesthesiologist.




Primary Outcome Measures :
  1. Dosage/consumption [ Time Frame: Through the completion of the study, up to 1 year ]
  2. Incidence of patient movement and MRI interruption [ Time Frame: Through the completion of the study, up to 1 year ]
  3. Incidence of adverse events [ Time Frame: Through the completion of the study, up to 1 year ]
    arterial desaturation, airway obstruction, hypotension and bradycardia

  4. Case Times [ Time Frame: Through the completion of the study, up to 1 year ]
    Time of initiation of Dexmedetomidine infusion, time participant meets sedation criteria for MRI scan, start and stop times of infusions of dexmedetomidine and propofol, arrival and exit time in MRI suite, time participant wakes up in Post Anesthesia Care Unit (eye opening), time participant is fully responsive, time participant is "ready for Post Anesthesia Care Unit discharge". All times are recorded in the 24-hour notation.


Secondary Outcome Measures :
  1. Incidence of technique failure [ Time Frame: Through the completion of the study, up to 1 year ]
    lack of adequate sedation for MRI scan in spite of the sedation as described above



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Ages Eligible for Study:   1 Year to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 the sedation technique described in this study with a natural airway (see exclusion criteria described below). This decision will be made by a staff member of the Department of Anesthesiology.
  3. The subjects must be 1 and 12 years.
  4. The subject's legally authorized representative has given written informed consent to participate in the study.
  5. American Society of Anesthesiologist status I, II, or III

Exclusion Criteria:

  1. The subject is residing in the Pediatric Intensive Care Unit, the Cardiac Intensive Care Unit, or Neonatal Intensive Care Unit.
  2. Diagnosis of a difficult airway or severe obstructive sleep apnea that is not compatible with spontaneous ventilation in a supine position.
  3. Congenital heart disease or history of dysrhythmia.
  4. Patient taking digoxin or beta-blocker
  5. Anxiolytic medication is ordered before the MRI (e.g., midazolam or ketamine).
  6. The subject has a history or a family (parent or sibling) history of malignant hyperthermia.
  7. The subject is allergic to or has a contraindication to propofol or dexmedetomidine.
  8. The subject has previously been treated under this protocol.
  9. The subject has a tracheostomy or other mechanical airway device.
  10. 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).
  11. The subject is not scheduled to receive anesthesia-sedation care for the MRI.
  12. The subject received one of the anesthetic regimens for the same MRI during the past six months.

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): NCT02633241


Locations
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United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Joseph P. Cravero
Investigators
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Principal Investigator: Joseph Cravero, MD Boston Children’s Hospital

Publications:
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Responsible Party: Joseph P. Cravero, MD, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT02633241     History of Changes
Other Study ID Numbers: IRB-P00019084
First Posted: December 17, 2015    Key Record Dates
Last Update Posted: April 26, 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

Keywords provided by Joseph P. Cravero, Boston Children’s Hospital:
pediatrics
sedation
dexmedetomidine
propofol
MRI

Additional relevant MeSH terms:
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Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Propofol
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action