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Evaluating the Effects of Propofol vs. Dexmedetomidine

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ClinicalTrials.gov Identifier: NCT03552146
Recruitment Status : Recruiting
First Posted : June 11, 2018
Last Update Posted : July 24, 2019
Sponsor:
Collaborator:
Morehouse School of Medicine
Information provided by (Responsible Party):
David Fagin, MD, Children's Healthcare of Atlanta

Brief Summary:
The primary purpose of this observational study is to compare what drugs work best in sedating children (> 3 months to < 36 months) who need an MRI. This type of research may help clinicians (healthcare providers) learn more about how dexmedetomidine works compared to propofol. The investigators are planning to have 60 children complete the study at Children's Healthcare of Atlanta at Scottish Rite. Half (30) of the patients will be randomized to receive dexmedetomidine and the other half will receive propofol. (Both drugs are licensed and approved for the sedation performed for consented patients.)

Condition or disease Intervention/treatment
Sedative Adverse Reaction Drug: Propofol Drug: Dexmedetomidine

Detailed Description:
There are several different medications commonly being used to facilitate the administration of radiologic procedures on children. Procedures such as Magnetic Resonance Imaging (MRIs) require that the patient remain still for the duration of the test. Propofol has become the drug of choice for many sedation services due to its rapid onset of action, rapid recovery time, ability to achieve sedation reliably and favorable safety profile. Dexmedetomidine, a selective alpha-2- adrenergic agonist, has also gained popularity with sedation services. Its main advantage over propofol is that it has minimal respiratory complications when compared to propofol. The sedative effect from dexmedetomidine preserves a natural sleep pattern and induces cooperative sedation in which patients are easily arousable. In pediatric studies, the most frequent adverse effect have been related to its potential to cause hypotension and bradycardia, which resolve with dose reduction. Additionally, dexmedetomidine does not seem to have as much impairment of cognitive function and has an opioid sparing effect. Dexmedetomidine, however, has a longer onset of action and longer recovery time compared to propofol, which has limited its use with many sedation services.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Effects on Efficiency of a Sedation Service by Switching From Propofol to Dexmedetomidine
Actual Study Start Date : July 24, 2018
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Sedation Group 1
Patients will receive standard of care dose of Propofol, based on the provider's assessment, prior to radiologic procedure.
Drug: Propofol
Patients will be randomized to either propofol or dexmedetomidine and then observed for sedation-related events from time of drug administration to discharge.
Other Name: Diprivan

Sedation Group 2
Patients will receive standard of care dose of dexmedetomidine, based on the provider's assessment, prior to radiologic procedure.
Drug: Dexmedetomidine
Patients will be randomized to either propofol or dexmedetomidine and then observed for sedation-related events from time of drug administration to discharge.
Other Name: Precedex




Primary Outcome Measures :
  1. Procedural times to achieve optimal sedation [ Time Frame: Start of procedure to discharge (up to 8 hours) ]
    Measuring the amount of time it takes for a patient to be discharged starting from induction (start of infusion).


Secondary Outcome Measures :
  1. Sedation related events [ Time Frame: Start of procedure to up to 36 hours post-discharge ]
    Adverse events related to the sedation (i.e., apnea, desaturation, change in heart rate)


Other Outcome Measures:
  1. Post-discharge clinical status [ Time Frame: Baseline to 24 hours post discharge ]
    Recording any events post-discharge that are possibly sedation-related



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Ages Eligible for Study:   3 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The study will draw from children who are scheduled for non emergent sedation to undergo a brain non contrast, magnetic resonance imaging (MRI) study. Children are otherwise healthy and fall within the age span of 3 months to 36 months. This is an observational study of the outcomes outlined, when patients agree to be randomized to either of 2 drugs which are FDA approved to provide optimal sedation for this MRI procedure.
Criteria

Inclusion Criteria:

  1. Patient (or Parent/Guardian) is English speaking
  2. Patient is undergoing a scheduled, elective non-contrast MRI of the brain
  3. Patient is > 3 months to <36 months of age

Exclusion Criteria:

  1. Patients undergoing MRI with contrast
  2. Patients older than 36 months of age or younger than 3 months of age
  3. Patients presenting to Emergency Department (ED) out of screening hours
  4. Patients who are not English speaking
  5. Patients who have history or record of propofol or dexmedetomidine allergy
  6. Patients with known or history of anaphylaxis to eggs, egg products, soybeans, or soy based products; if patient has a history of a hypersensitivity reaction associated with exposure to eggs, egg products, soybeans, or soy based products, approval must be given by the treating attending physician and documented on the patient's medical record.
  7. Patients with unstable cardiac or respiratory status as determined by treating attending physician
  8. Patients who are receiving digoxin

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): NCT03552146


Contacts
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Contact: David Fagin, MD 404-785-6000 david.fagin@pema.com
Contact: Lilly H Immergluck, MD 404-785-6000 lilly.immergluck@pema.com

Locations
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United States, Georgia
Children's Healthcare of Atlanta Recruiting
Atlanta, Georgia, United States, 30342
Sponsors and Collaborators
Children's Healthcare of Atlanta
Morehouse School of Medicine

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Responsible Party: David Fagin, MD, Assistant Medical Director, Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier: NCT03552146     History of Changes
Other Study ID Numbers: 17-136
First Posted: June 11, 2018    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: This is a pilot study of observations made of patients who are randomized to receive 1 of 2 sedation medications, which are currently FDA approved for the proposed study. The data will help researchers determine the feasibility to conduct a large scale multi-center study to look specifically at primary outcomes as outlined in the proposal.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by David Fagin, MD, Children's Healthcare of Atlanta:
sedation
Additional relevant MeSH terms:
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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