High Dose Steroids for Dysphagia

Overview

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.

Full Title of Study: “Effect of High Dose Steroids on Dysphagia After Anterior Spinal Surgery: a Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: November 2018

Interventions

  • Drug: Dexamethasone
  • Drug: Placebo
    • Normal saline (IV placebo)

Arms, Groups and Cohorts

  • Experimental: Treatment group
    • Dexamethasone, 4 mg IV given at 8 hours interval, first dose received at the time of surgery (induction), 3 doses total
  • Placebo Comparator: Placebo group
    • Saline given at 8 hours interval, first dose received at the time of surgery (induction), 3 doses total

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

Inclusion Criteria

  • Anterior cervical spine surgery – Elective surgery Exclusion Criteria:

  • Takes steroids for any reason – Pre-existing condition leading to dysphagia

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centre hospitalier de l’Université de Montréal (CHUM)
  • Provider of Information About this Clinical Study
    • Sponsor

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