Perioperative Steroid Dosing on the APR in AIS

NCT05561725 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: STUDY00003378
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Adolescent Idiopathic Scoliosis (AIS)

Keywords

Steroid; Perioperative; Posterior Spinal Fusion (PSF); Dexamethasone

Outcome Measures

Primary Outcomes (2)

• Changes in C-Reactive Protein

  Laboratory studies to be collected will include c-reactive protein (CRP). Laboratory studies will be performed prior to surgery, post-operatively in the post-anesthesia care unit, and every morning during the in-hospital stay up to 48 hours. Studies will be analyzed in the hospital laboratory using standard sample analysis. No more than 10cc will be collected at each lab draw.

  Immediately pre-surgery, immediately post-surgery, 24 hours post-surgery, 48 hours post-surgery

• Changes in Interleukin-6

  Laboratory studies to be collected will include IL-6. Laboratory studies will be performed prior to surgery, post-operatively in the post-anesthesia care unit, and every morning during the in-hospital stay up to 48 hours. Studies will be analyzed in the hospital laboratory using standard sample analysis. No more than 10cc will be collected at each lab draw.

  Immediately pre-surgery, immediately post-surgery, 24 hours post-surgery, 48 hours post-surgery

Secondary Outcomes (1)

• Changes in Total morphine usage

  Immediately post surgery, 24 hours post-surgery and 48 hours post-surgery

Study Arms (2)

Standard of Care: Control

ACTIVE COMPARATOR

Patients will be screened for participation following indication for surgery by the treating surgeon and/or research assistant. Patients who elect to participate will then be randomized into either the dexamethasone or control groups. Patients in the control group will receive one 8mg dose of dexamethasone intraoperatively as per standard of care anesthesia protocols. No sham medication will be utilized for control subjects.

Drug: Standard of Care

Dexamethasone

EXPERIMENTAL

Patients will be screened for participation following indication for surgery by the treating surgeon and/or research assistant. Patients who elect to participate will then be randomized into either the dexamethasone or control groups. Patients randomized to the dexamethasone cohort will be administered 8 mg of dexamethasone with 3 additional (8mg doses) administered at 8-hour intervals following surgery for a total of 4 doses.

Drug: Dexamethasone postoperative

Interventions

Dexamethasone postoperative DRUG

Patients randomized to the dexamethasone cohort will be administered 8 mg of dexamethasone with 3 additional (8mg doses) administered at 8-hour intervals following surgery for a total of 4 doses. All patients will undergo a standardized post-operative pathway in the hospital following surgery that has been utilized for all AIS patients at our center since 2014.

Dexamethasone

Standard of Care DRUG

Patients in the control group will receive one 8mg dose of dexamethasone intraoperatively as per standard of care anesthesia protocols. No sham medication will be utilized for control subjects. All patients will undergo a standardized post-operative pathway in the hospital following surgery that has been utilized for all AIS patients at our center since 2014.

Standard of Care: Control

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• All patients ages 10-18 with AIS who are undergoing a PSF performed by Dr. Nicholas Fletcher at Children's Healthcare of Atlanta Egleston will be considered eligible for the study

You may not qualify if:

• Adults \> 18 years old
• Pregnant women
• Prisoners
• Patients with systemic fungal infections

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Children Healthcare of Atlanta

Atlanta, Georgia, 30329, United States

RECRUITING

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Nicholas Fletcher, MD

  Associate Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicholas Fletcher, MD

CONTACT

404-255-1933; nicholas.d.fletcher@emory.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 20, 2022
• First Posted: September 30, 2022
• Study Start: January 3, 2023
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)