drugset / Trial / NCT03256149

High Dose Steroids for Dysphagia

NCT03256149 ↗

RandomizedSingle-groupTriple-blindPrevention

Summary

Few existing data currently indicates that anti-inflammatory drugs could help diminish the local cervical inflammation tough to cause the dysphagia, hoarseness and dyspnea after an anterior surgical approach to the spine. This study aims to evaluate the effect of high dose of steroids on dysphagia after an anterior cervical spine procedure. Patients subjected to a cervical spine surgery through an anterior approach will be randomized to a treatment group receiving 3 doses of IV dexamethasone (decadron) and a placebo group receiving saline. Outcome will be measured with dysphagia scales, modified barium swallow and rhino-pharyngo-laryngoscopy, all done pre and post-operatively. Secondary outcomes involve neurological condition, pain and fusion rate.

Timeline

Start
2015-03-24
Primary completion
2018-11
Completion
2019-02

Outcome

Outcome not reported

Stopped: “Not enough patients recruted”

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule 4 mg Intravenous