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Evaluating the Effects of Propofol vs. Dexmedetomidine

NCT03552146 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2019-07-24

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Morehouse School of Medicine

    collaborator OTHER

  • Children's Healthcare of Atlanta

    lead OTHER

Eligibility

Min Age
3 Months
Max Age
36 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-24
Primary Completion
2019-09-30
Completion
2019-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03552146 on ClinicalTrials.gov