Efficacy of Corticosteroid Therapy on Neurological Outcomes in Near-Hanging Patients With Altered Sensorium: Protocol for a Multicenter, Double-Blinded, Placebo-Controlled, Randomized Trial (CHANGING Trial)

Background: In India, hanging is the leading method of suicide, and survivors of near-hanging often present with altered sensorium due to cerebral edema from cervical vascular compression and hypoxia. Management typically involves supportive care and antiedema measures, such as mannitol, hypertonic saline, and dexamethasone. Dexamethasone, a corticosteroid that crosses the blood-brain barrier, is commonly used for presumed cerebral edema. However, evidence supporting its efficacy is limited, and there are no clinical guidelines that recommend its routine use. A randomized controlled trial is therefore essential to establish the real-world efficacy of dexamethasone in this setting. Objective: The primary objective of this study is to evaluate the efficacy of intravenous dexamethasone, compared with placebo, in achieving good neurological outcomes at day 28. Secondary objectives are to assess the efficacy of dexamethasone, compared with placebo, in improving neurological outcomes at hospital discharge. We will also compare the duration of hospital stay and the incidence of in-hospital complications between patients receiving dexamethasone and those receiving a placebo. Methods: The CHANGING trial (Corticosteroids in HANGING) is a multicenter, double-blind, randomized, placebo-controlled study at 3 Indian tertiary centers. It enrolls 192 near-hanging patients with a Glasgow Coma Scale score ≤13 over 3 years, randomizing them in a 1:1 ratio to IV dexamethasone or placebo, plus standard care for 3 to 5 days. The primary outcome is neurological recovery at day 28, assessed using the Glasgow Outcome Scale. Secondary outcomes include the Glasgow Outcome Scale at discharge, duration of hospital stay, and the incidence of in-hospital complications. This trial has been approved by Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry Institute Ethics Committee (January 22, 2025), with subsequent approvals from Indira Gandhi Medical College and Research Institute (April 8, 2025) and Postgraduate Institute of Medical Education and Research (August 26, 2025). Results: The study commenced in October 2025 and is planned to be completed by May 2028. It is currently ongoing, and patient recruitment is in progress. Results will be analyzed after completion of enrollment and follow-up and will be disseminated through peer-reviewed publications. Conclusions: Corticosteroids are widely used for cerebral edema after near-hanging, but their role is unclear. The CHANGING trial will test dexamethasone's efficacy and safety in these patients to guide future practice and guidelines.