Recruiting

Propofol vs. Dexmedetomidine

Sponsor:

Children's Healthcare of Atlanta

Code:

NCT03552146

Conditions

Sedative Adverse Reaction

Eligibility Criteria

Sex: All

Age: 0 - 3

Healthy Volunteers: Accepted

Interventions

Propofol

Dexmedetomidine

Study Details

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

Study ID

NCT03552146

Start date

Jul 24, 2018

Status verified date

Jul, 2019

Completion date

Sep 30, 2019

Anticipated

Primary completion date

Sep 30, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 3

Healthy Volunteers: Accepted

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 Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

Sedation Group 1

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

Sedation Group 2

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

Interventions

Propofol

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

Dexmedetomidine

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

Primary outcome measure

  • Procedural times to achieve optimal sedation [ Time Frame: Start of procedure to discharge (up to 8 hours) ]

Central Contacts and Locations

Central contacts

David Fagin, MD

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

Lilly H Immergluck, MD

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

Locations

Children's Healthcare of Atlanta

Recruiting

Atlanta, Georgia, United States, 30342

More Information

Sponsor

Children's Healthcare of Atlanta

Last update posted

Jul 24, 2019

Last verified

Jul, 2019

Keywords

  • sedation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Healthcare of Atlanta on 2019-07-24.