Cervical Spine Disease, Dysphagia
Conditions
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.
Interventions
DRUGDexamethasone
DRUGPlacebo
Normal saline (IV placebo)
Sponsors
Centre hospitalier de l'Université de Montréal (CHUM)
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Anterior cervical spine surgery * Elective surgery
Exclusion criteria
* Takes steroids for any reason * Pre-existing condition leading to dysphagia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Voice evaluation | First day post-operatively | Voice handicap index |
| Dysphagia evaluation: MBSimp | First day post-operatively | Modified Barium Swallow with the calculation fof the MBSimp score |
| Soft tissue edema | First day post-operatively | Pre-vertebral soft tissue edema on X Ray |
| Airway evaluation | First day post-operatively | Rhino-Pharyngo-Laryngoscopy |
| Dysphagia evaluation: Rosenbeck | First day post-operatively | Modified Barium Swallow with calculation of the Rosenbeck score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hyperreflexia | 3 months post-operatively | hyperreflexia assesment using osteotendinous reflexes graded on a 1 to 4 scale |
| Surgical site infection | 3 months after surgery | Presence or absence of superficial or deep surgical site infection |
| Fusion rate | 6 months after surgery | Cervical spine fusion at site of surgery seen on CT scan |
| Pain | 3 months after surgery | Subjective neck pain using analog pain scale |
| Strenght | 3 months after surgery | 4 limbs strengh assessment on a 0 to 5 scale |
| Crude touch sensation | 3 months after surgery | Presence or absence of hypoesthesia in the limbs |
Countries
Canada
Outcome results
None listed