← Back to Search

Corticosteroid

Treatment group for Swallowing Difficulty (SHDD Trial)

N/A
Waitlist Available
Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Anterior cervical spine surgery
Elective surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months after surgery
Awards & highlights

SHDD Trial 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.

Eligible Conditions
  • Swallowing Difficulty
  • Cervical Spine Disease

SHDD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

SHDD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months after surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months after surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Airway evaluation
Dysphagia evaluation: MBSimp
Dysphagia evaluation: Rosenbeck
+2 more
Secondary outcome measures
Crude touch sensation
Fusion rate
Hyperreflexia
+3 more

Side effects data

From 2013 Phase 4 trial • 122 Patients • NCT01474915
2%
Deep Vein Thrombosis
2%
Cerebrospinal fluid leak
2%
Fever
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ondansetron
Aprepitant

SHDD Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment groupExperimental Treatment1 Intervention
Dexamethasone, 4 mg IV given at 8 hours interval, first dose received at the time of surgery (induction), 3 doses total
Group II: Placebo groupPlacebo Group1 Intervention
Saline given at 8 hours interval, first dose received at the time of surgery (induction), 3 doses total
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
FDA approved

Find a Location

Who is running the clinical trial?

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
365 Previous Clinical Trials
129,309 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~0 spots leftby Mar 2025