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NCT05561725 · ClinicalTrials.gov registry record · Phase 4
Perioperative Steroid Dosing on the APR in AIS
A Phase 4 study of Adolescent Idiopathic Scoliosis (AIS), sponsored by Emory University.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT05561725 is a Phase 4 study of Adolescent Idiopathic Scoliosis (AIS) that is actively recruiting participants, run by Emory University. The registered enrollment target is 50 participants. The trial reports 1 study location across 1 state.
The verdict
NCT05561725, a Phase 4 study of Adolescent Idiopathic Scoliosis (AIS), is actively recruiting participants, sponsored by Emory University.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
The objective of this study is to perform a prospective, randomized controlled trial investigating the clinical usage of perioperative dexamethasone usage on APR activation, postoperative morphine usage, postoperative nausea, and hospital length of stay. There will be a control control and a Dexamethasone cohort. Participants will be randomized into one of the two cohorts. Patients in the control group will receive one 8mg dose of dexamethasone intraoperatively as per standard of care anesthesia protocols. Patients randomized to the dexamethasone cohort will be administered 8 mg of dexamethasone with 3 additional doses administered at 8-hour intervals following surgery for a total of 4 doses. All study activities will tale place at Egleston during the patient's planned inpatient stay for their posterior spinal fusion. This project has the potential to validate the utility of dexamethasone as a way to optimize postoperative care following PSF for AIS by minimizing the need for opioid medications and enhancing mobility and recovery.
Conditions Studied
Interventions
- DRUG Standard of Care
- DRUG Dexamethasone postoperative
Study Locations (1)
Georgia
- Children Healthcare of Atlanta - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2023-01-03 |
| Est. Completion | 2026-03 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05561725
The ClinicalTrials.gov registry entry for NCT05561725 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Adolescent Idiopathic Scoliosis (AIS) appearing as the primary indexed condition, and to 2 interventions - of which Standard of Care is the first listed.
NCT05561725 reports 1 study location spanning 1 distinct geographic area - top geographies include Georgia.
Frequently Asked Questions
What is clinical trial NCT05561725 about?
NCT05561725 is a clinical study titled "Perioperative Steroid Dosing on the APR in AIS". The objective of this study is to perform a prospective, randomized controlled trial investigating the clinical usage of perioperative dexamethasone usage on APR activation, postoperative morphine usage, postoperative nausea, and hospital length of stay. There will be a control control and a Dexame...
What is the current status of trial NCT05561725?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 50 participants. The study started on 2023-01-03. Estimated completion is 2026-03.
What conditions does trial NCT05561725 study?
This clinical trial studies the following conditions: Adolescent Idiopathic Scoliosis (AIS).
What interventions are being tested in trial NCT05561725?
The interventions under investigation include: Standard of Care (DRUG), Dexamethasone postoperative (DRUG).
Who is sponsoring clinical trial NCT05561725?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05561725 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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