RECRUITING

Perioperative Steroid Dosing on the APR in AIS

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Impact of Perioperative Steroid Dosing on the Acute Phase Response in Adolescent Idiopathic Scoliosis

Quick Facts

Study Start:2023-01-03
Study Completion:2024-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05561725

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:10 Years to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  1. * Patients outside the inclusion parameters or with congenital or syndromic scoliosis
  2. * Adults \> 18 years old
  3. * Pregnant women
  4. * Prisoners
  5. * Patients with systemic fungal infections

Contacts and Locations

Study Contact

Nicholas Fletcher, MD
CONTACT
404-255-1933
nicholas.d.fletcher@emory.edu

Principal Investigator

Nicholas Fletcher, MD
PRINCIPAL_INVESTIGATOR
Associate Professor

Study Locations (Sites)

Children Healthcare of Atlanta
Atlanta, Georgia, 30329
United States

Collaborators and Investigators

Sponsor: Emory University

  • Nicholas Fletcher, MD, PRINCIPAL_INVESTIGATOR, Associate Professor

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-03
Study Completion Date2024-12

Study Record Updates

Study Start Date2023-01-03
Study Completion Date2024-12

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Adolescent Idiopathic Scoliosis (AIS)