NCT03256149

High Dose Steroids for Dysphagia

Effect of High Dose Steroids on Dysphagia After Anterior Spinal Surgery: a Randomized Controlled Trial

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dysphagia
• Cervical Spine Disease

Interventions

Type	Name	Description
DRUG	Dexamethasone
DRUG	Placebo	Normal saline (IV placebo)

Timeline

• Start date: 2015-03-24
• Primary completion: 2018-11-01
• Completion: 2019-02-01
• First posted: 2017-08-21
• Last updated: 2022-12-14

Locations

1 site across 1 country: Canada