Evaluating the Effects of Propofol vs. Dexmedetomidine

NCT03552146 | Unknown FDA Drug

• 1 other identifier: 17-136
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.)

Conditions

Sedative Adverse Reaction

Keywords

sedation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Sedation related events

  Start of procedure to up to 36 hours post-discharge

Other Outcomes (1)

• Post-discharge clinical status

  Baseline to 24 hours post discharge

Study Arms (2)

Sedation Group 1

Patients will receive standard of care dose of Propofol, based on the provider's assessment, prior to radiologic procedure.

Drug: Propofol

Sedation Group 2

Patients will receive standard of care dose of dexmedetomidine, based on the provider's assessment, prior to radiologic procedure.

Drug: Dexmedetomidine

Interventions

Propofol DRUG

Patients will be randomized to either propofol or dexmedetomidine and then observed for sedation-related events from time of drug administration to discharge.

Also known as: Diprivan

Sedation Group 1

Dexmedetomidine DRUG

Patients will be randomized to either propofol or dexmedetomidine and then observed for sedation-related events from time of drug administration to discharge.

Also known as: Precedex

Sedation Group 2

Eligibility Criteria

• Age: 3 Months - 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• Patients undergoing MRI with contrast
• Patients older than 36 months of age or younger than 3 months of age
• Patients presenting to Emergency Department (ED) out of screening hours
• Patients who are not English speaking
• Patients who have history or record of propofol or dexmedetomidine allergy
• 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.
• Patients with unstable cardiac or respiratory status as determined by treating attending physician
• Patients who are receiving digoxin

Sponsors & Collaborators

• Children's Healthcare of Atlanta: lead
• Morehouse School of Medicine: collaborator

Study Sites (1)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30342, United States

RECRUITING

MeSH Terms

Interventions

Propofol; Dexmedetomidine

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

David Fagin, MD

CONTACT

404-785-6000; david.fagin@pema.com

Lilly H Immergluck, MD

CONTACT

404-785-6000; lilly.immergluck@pema.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Medical Director

Study Record Dates

• First Submitted: March 30, 2018
• First Posted: June 11, 2018
• Study Start: July 24, 2018
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: July 24, 2019

Record last verified: 2019-07

Locations

US (1)