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NCT04798482 · ClinicalTrials.gov registry record · Phase 4
Effect of Dexmedetomidine of Gastrointestinal Motility
A Phase 4 study, sponsored by Boston Children's Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 22
- Enrollment target
NCT04798482 is a Phase 4 study that has completed, run by Boston Children's Hospital. The registered enrollment target is 22 participants.
The verdict
NCT04798482, a Phase 4 study, has completed, sponsored by Boston Children's Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 22 participants
- Enrollment target
Study Summary
Anorectal manometry requires that the patient be able to respond to command and not receive any medications which could alter muscle tone or motility. In the pediatric population, anorectal manometry can be psychologically challenging to parents and their child, as it is traditionally performed without adjuvant sedation or anesthesia. Sedatives and anesthesia can alter motility and smooth muscle activity, as well as render it difficult or impossible for the child to follow commands required of the study. Patient or parent non-compliance, inability to follow commands or to tolerate the procedure often renders the study invalid or impossible to complete. Dexmedetomidine is a sedative who's effect on anorectal musculature has not been studied nor determined. It would be important to determine whether it spares smooth muscle function, as it would provide a viable option to provide sedation to children while still preserving their ability to respond to command. The primary objective of this study is to examine the effects of dexmedetomidine on gastrointestinal smooth muscle by observing changes in anorectal manometry before and after dexmedetomdine administration.
Interventions
- DRUG Dexmedetomidine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2021-09-14 |
| Est. Completion | 2022-11-15 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04798482
The ClinicalTrials.gov registry entry for NCT04798482 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Children's Hospital, which has 462 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Dexmedetomidine is the first listed.
NCT04798482 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04798482 about?
NCT04798482 is a clinical study titled "Effect of Dexmedetomidine of Gastrointestinal Motility". Anorectal manometry requires that the patient be able to respond to command and not receive any medications which could alter muscle tone or motility. In the pediatric population, anorectal manometry can be psychologically challenging to parents and their child, as it is traditionally performed with...
What is the current status of trial NCT04798482?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 22 participants. The study started on 2021-09-14. Estimated completion is 2022-11-15.
What interventions are being tested in trial NCT04798482?
The interventions under investigation include: Dexmedetomidine (DRUG).
Who is sponsoring clinical trial NCT04798482?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
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