Evaluating the Effects of Propofol vs. Dexmedetomidine

NCT ID: NCT03552146

Last Updated: 2019-07-24

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-07-24
• Study Completion Date: 2019-09-30

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.)

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.

Conditions

Sedative Adverse Reaction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Sedation Group 1

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

Propofol

Intervention Type: DRUG

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

Sedation Group 2

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

Dexmedetomidine

Intervention Type: DRUG

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

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Diprivan; Precedex

Eligibility 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

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 36 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Morehouse School of Medicine

OTHER

Sponsor Role: collaborator

Children's Healthcare of Atlanta

OTHER

Sponsor Role: lead

Responsible Party

David Fagin, MD

Assistant Medical Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

David Fagin, MD

Role: CONTACT

david.fagin@pema.com

404-785-6000

Lilly H Immergluck, MD

Role: CONTACT

lilly.immergluck@pema.com

404-785-6000

Other Identifiers

17-136

Identifier Type: -

Identifier Source: org_study_id