An interventional study of Dexamethasone and Placebo in Dysphagia and Cervical Spine Disease, sponsored by Centre hospitalier de l'Université de Montréal (CHUM). Withdrawn at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-14.
Sponsored by Centre hospitalier de l'Université de Montréal (CHUM) · Not applicable, Interventional, and Prevention
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.
Exclusion Criteria:
Dexamethasone, 4 mg IV given at 8 hours interval, first dose received at the time of surgery (induction), 3 doses total
Drug: Dexamethasone
Saline given at 8 hours interval, first dose received at the time of surgery (induction), 3 doses total
Drug: Placebo
Also known as: Decradron
Normal saline (IV placebo)
Also known as: Saline
Voice evaluation
Voice handicap index
Time frame: First day post-operatively
Dysphagia evaluation: MBSimp
Modified Barium Swallow with the calculation fof the MBSimp score
Time frame: First day post-operatively
Soft tissue edema
Pre-vertebral soft tissue edema on X Ray
Time frame: First day post-operatively
Airway evaluation
Rhino-Pharyngo-Laryngoscopy
Time frame: First day post-operatively
Dysphagia evaluation: Rosenbeck
Modified Barium Swallow with calculation of the Rosenbeck score
Time frame: First day post-operatively
Hyperreflexia
hyperreflexia assesment using osteotendinous reflexes graded on a 1 to 4 scale
Time frame: 3 months post-operatively
Fusion rate
Cervical spine fusion at site of surgery seen on CT scan
Time frame: 6 months after surgery
Pain
Subjective neck pain using analog pain scale
Time frame: 3 months after surgery
Strenght
4 limbs strengh assessment on a 0 to 5 scale
Time frame: 3 months after surgery
Crude touch sensation
Presence or absence of hypoesthesia in the limbs
Time frame: 3 months after surgery
Surgical site infection
Presence or absence of superficial or deep surgical site infection
Time frame: 3 months after surgery
Plan to share: Undecided
No publications or documents are linked to this record.
This study is withdrawn, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Centre hospitalier de l'Université de Montréal (CHUM)