drugset / Trial / NCT05561725

Perioperative Steroid Dosing on the APR in AIS

NCT05561725 ↗

Phase 4 Completed 42 enrolled Emory University
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2023-01-03
Primary completion
2026-04-01
Completion
2026-04-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule 8 mg —