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NCT03513757 · ClinicalTrials.gov registry record · Phase 4
Dexmedetomidine and Propofol for Pediatric MRI Sedation
A Phase 4 study, sponsored by Medical College of Wisconsin.
- Completed
- Registry status
- Phase 4
- Development phase
- 40
- Enrollment target
NCT03513757 is a Phase 4 study that has completed, run by Medical College of Wisconsin. The registered enrollment target is 40 participants.
The verdict
NCT03513757, a Phase 4 study, has completed, sponsored by Medical College of Wisconsin.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 40 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the results of combining two anesthetic medications (dexmedetomidine and propofol) in low doses with a standard dose of a single drug that is commonly used to provide sedation/anesthesia for MRI studies in young children (propofol). The drugs used for the MRI scan in this study will be chosen randomly. Half the patients will receive small doses of propofol and dexmedetomidine. The other half will receive propofol administered constantly throughout the scan. Other drugs that may be used include sevoflurane and nitrous oxide at the start of the sedation (for placing an intravenous), lidocaine (to reduce the pain of propofol injection) and glycopyrrolate (to prevent the heart rate from decreasing too low. The investigators will record 5 additional blood pressures and heart rates. If additional medications are required to complete the scan, the investigators will administer whatever is necessary. At the end of the study, the investigators will have an observer record the time it takes for participants to spontaneously open eyes , to be able to drink liquids and/or eat and to behave as before the study. Also, it is very important that the investigators find out from participants about changes in behavior, or if eating or sleeping habits were unusual following completion of the study. For that reason, the investigators will call participants in a day or so following the MRI scan. The investigators expect to recruit 40 children between the ages of 12 and 72 months for the study and hope to have the study completed in December 2018.
Interventions
- DRUG Dexmedetomidine
- DRUG Nitrous Oxide
- DRUG Glycopyrrolate
- DRUG Lidocaine 1% Injectable Solution
- DRUG propofol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2018-03-04 |
| Est. Completion | 2018-10-21 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03513757
The ClinicalTrials.gov registry entry for NCT03513757 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical College of Wisconsin, which has 447 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Dexmedetomidine is the first listed.
NCT03513757 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03513757 about?
NCT03513757 is a clinical study titled "Dexmedetomidine and Propofol for Pediatric MRI Sedation". The purpose of this study is to compare the results of combining two anesthetic medications (dexmedetomidine and propofol) in low doses with a standard dose of a single drug that is commonly used to provide sedation/anesthesia for MRI studies in young children (propofol). The drugs used for the MRI...
What is the current status of trial NCT03513757?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2018-03-04. Estimated completion is 2018-10-21.
What interventions are being tested in trial NCT03513757?
The interventions under investigation include: Dexmedetomidine (DRUG), Nitrous Oxide (DRUG), Glycopyrrolate (DRUG), Lidocaine 1% Injectable Solution (DRUG), propofol (DRUG).
Who is sponsoring clinical trial NCT03513757?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
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