Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02633241
Recruitment Status : Active, not recruiting
First Posted : December 17, 2015
Results First Posted : August 28, 2019
Last Update Posted : July 22, 2020
Sponsor:
Information provided by (Responsible Party):
Joseph 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
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 2020

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: Prior to beginning the MRI and throughout the MRI scan - approximately one hour. ]
    Dosage and consumption of dexmedetomidine

  2. Incidence of Patient Movement and MRI Interruption [ Time Frame: During the MRI scan, until completion, approximately one hour. ]
    If patient moved during their MRI and caused an interruption of the scan.

  3. Incidence of Adverse Events [ Time Frame: From the time the medication is initiated just (5 minutes) prior to the MRI scan and during the MRI scan and immediately during recovery - approximately one hour and twenty minutes in total. ]
    arterial desaturation, airway obstruction, hypotension and bradycardia

  4. Case Times [ Time Frame: Timeframe immediately before the MRI scan while sedation medication is administered - approximately 10 minutes ]
    Number of minutes from the start of sedation medication administration to the time the patient is adequately sedated for the MRI scan,


Secondary Outcome Measures :
  1. Incidence of Technique Failure [ Time Frame: During the MRI scan until completion - approximately one hour ]
    lack of adequate sedation for MRI scan in spite of the sedation as described above

  2. Sedation Infusion Time [ Time Frame: For the duration of the MRI scan - approximately one hour ]
    The number of minutes that the patient was receiving dexmedetomidine infusion,

  3. Case Duration [ Time Frame: Duration of the MRI scan - approximately one hour ]
    total number of minutes in the MRI scanner,

  4. Recovery Time [ Time Frame: from completion of the MRI scan until prepared for discharge - approximately 90 minutes ]
    number of minutes in the recovery area until the patient appeared awake (eye opening),



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Layout table for location information
United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Joseph Cravero
Investigators
Layout table for investigator information
Principal Investigator: Joseph Cravero, MD Boston Children's Hospital
  Study Documents (Full-Text)

Documents provided by Joseph Cravero, Boston Children's Hospital:
Publications:
Layout table for additonal information
Responsible Party: Joseph Cravero, MD, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT02633241    
Other Study ID Numbers: IRB-P00019084
First Posted: December 17, 2015    Key Record Dates
Results First Posted: August 28, 2019
Last Update Posted: July 22, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Joseph Cravero, Boston Children's Hospital:
pediatrics
sedation
dexmedetomidine
propofol
MRI
Additional relevant MeSH terms:
Layout table for MeSH terms
Cerebral Palsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Brain Damage, Chronic
Dexmedetomidine
Propofol
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