Phase 4 N=78 Randomized Double-blind Prevention

Dysphagia Following Anterior Cervical Spine Surgery; Single Dose Steroid vs Saline (DysDexVSSal)

Dysphagia

Bottom Line

View on ClinicalTrials.gov: NCT03711474 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2025

Primary outcome: Primary: Change in the Occurrence of Dysphagia -Bazaz Scale — 2.17; 3.27 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Dexamethasone (Drug); Saline (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: West Virginia University
Primary completion: Jul 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in the Occurrence of Dysphagia -Bazaz Scale	0.28; 0.06	—
PRIMARY Change in the Occurrence of Dysphagia -Bazaz Scale	0.28; 0.06	—
PRIMARY Change in the Occurrence of Dysphagia -Bazaz Scale	0.28; 0.06	—
PRIMARY Change in the Occurrence of Dysphagia -Bazaz Scale	0.28; 0.06	—
PRIMARY Change in the Occurrence of Dysphagia -Bazaz Scale	0.28; 0.06	—
PRIMARY Change in the Occurrence of Dysphagia -Bazaz Scale	0.28; 0.06	—
PRIMARY Change in the Occurrence of Dysphagia -Bazaz Scale	0.28; 0.06	—
PRIMARY Change in the Occurrence of Dysphagia -Bazaz Scale	0.28; 0.06	—
PRIMARY Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ).	0.86; 0.82	—
PRIMARY Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ).	0.86; 0.82	—
PRIMARY Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ).	0.86; 0.82	—
PRIMARY Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ).	0.86; 0.82	—
PRIMARY Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ).	0.86; 0.82	—
PRIMARY Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ).	0.86; 0.82	—
PRIMARY Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ).	0.86; 0.82	—
PRIMARY Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ).	0.86; 0.82	—
PRIMARY Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening.	2.09; 2.44	—
PRIMARY Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening.	2.09; 2.44	—
PRIMARY Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening.	2.09; 2.44	—
PRIMARY Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening.	2.09; 2.44	—
PRIMARY Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening.	2.09; 2.44	—
PRIMARY Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening.	2.09; 2.44	—
PRIMARY Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening.	2.09; 2.44	—
PRIMARY Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening.	2.09; 2.44	—

Summary

This prospective, randomized, double blind, controlled study evaluates the effect of a single dose of perioperative IV steroid versus saline on swallowing after anterior cervical spine surgery

Eligibility Criteria

Inclusion Criteria

Elective anterior approach to subaxial cervical spine (C3 - T1);
ages 18-80

Exclusion Criteria

Traumatic or tumor etiologies
undergoing anterior-posterior operations
neoplastic, or infectious conditions requiring surgery
a history of previous anterior cervical spine surgery
any patient requiring a halo vest
patients on chronic steroids
patients remaining intubated post-operatively (please see more under risks below)
less than 18 years of age
pregnant women
no phone

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03711474). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.