High Dose Steroids for Dysphagia

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Dysphagia, Cervical Spine Disease

Intervention / Treatment
-----------------
* Drug: Dexamethasone
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Anterior cervical spine surgery Elective surgery Exclusion Criteria: Takes steroids for any reason Pre-existing condition leading to dysphagia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>Dexamethasone, 4 mg IV given at 8 hours interval, first dose received at the time of surgery (induction), 3 doses total | Drug: Dexamethasone<br> <br> * Other names: Decradron;|
| Placebo Comparator: Placebo group<br>Saline given at 8 hours interval, first dose received at the time of surgery (induction), 3 doses total | Drug: Placebo<br>* Normal saline (IV placebo)<br>* Other names: Saline;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Voice evaluation | Voice handicap index | First day post-operatively | 
| Dysphagia evaluation: MBSimp | Modified Barium Swallow with the calculation fof the MBSimp score | First day post-operatively | 
| Soft tissue edema | Pre-vertebral soft tissue edema on X Ray | First day post-operatively | 
| Airway evaluation | Rhino-Pharyngo-Laryngoscopy | First day post-operatively | 
| Dysphagia evaluation: Rosenbeck | Modified Barium Swallow with calculation of the Rosenbeck score | First day post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hyperreflexia | hyperreflexia assesment using osteotendinous reflexes graded on a 1 to 4 scale | 3 months post-operatively | 
| Fusion rate | Cervical spine fusion at site of surgery seen on CT scan | 6 months after surgery | 
| Pain | Subjective neck pain using analog pain scale | 3 months after surgery | 
| Strenght | 4 limbs strengh assessment on a 0 to 5 scale | 3 months after surgery | 
| Crude touch sensation | Presence or absence of hypoesthesia in the limbs | 3 months after surgery | 
| Surgical site infection | Presence or absence of superficial or deep surgical site infection | 3 months after surgery |