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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | Dexamethasone, 4 mg IV given at 8 hours interval, first dose received at the time of surgery (induction), 3 doses total |
|
| Placebo group | Placebo Comparator | Saline given at 8 hours interval, first dose received at the time of surgery (induction), 3 doses total |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug |
|
| |
| Placebo |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier de l'Université de Montréal (CHUM) | Montreal | Quebec | H2L4M1 | Canada |
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| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Drug |
Normal saline (IV placebo) |
|
|
| 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 |
| D010038 | Otorhinolaryngologic Diseases |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |