NCT03552146

Evaluating the Effects of Propofol vs. Dexmedetomidine

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Children's Healthcare of Atlanta · Academic / Other
• Sex: All
• Age: 3 Months – 36 Months
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2018-07-24
• Primary completion: 2019-09-30
• Completion: 2019-09-30
• First posted: 2018-06-11
• Last updated: 2019-07-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study