Evaluating the Effects of Propofol vs. Dexmedetomidine

Evaluation of the Effects on Efficiency of a Sedation Service by Switching From Propofol to Dexmedetomidine

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.)

Study Overview

• Status: Unknown
• Conditions: Sedative Adverse Reaction
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: David Fagin, MD; Phone Number: 404-785-6000; Email: david.fagin@pema.com
• Study Contact Backup: Name: Lilly H Immergluck, MD; Phone Number: 404-785-6000; Email: lilly.immergluck@pema.com

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Recruiting
      • Children's Healthcare of Atlanta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 3 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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 Names: 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 Names: Precedex

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sedation related events	Adverse events related to the sedation (i.e., apnea, desaturation, change in heart rate)	Start of procedure to up to 36 hours post-discharge

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-discharge clinical status	Recording any events post-discharge that are possibly sedation-related	Baseline to 24 hours post discharge

Collaborators and Investigators

• Sponsor: Children's Healthcare of Atlanta
• Collaborators: Morehouse School of Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 24, 2018
• Primary Completion (ANTICIPATED): September 30, 2019
• Study Completion (ANTICIPATED): September 30, 2019

Study Registration Dates

• First Submitted: March 30, 2018
• First Submitted That Met QC Criteria: May 29, 2018
• First Posted (ACTUAL): June 11, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 24, 2019
• Last Update Submitted That Met QC Criteria: July 23, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: sedation
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Propofol; Dexmedetomidine
• Other Study ID Numbers: 17-136

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD 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.

Drug and device information, study documents

• 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