CompletedPhase 4

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

United States78 participantsStarted 2018-09-07

Plain-language 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

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in the Occurrence of Dysphagia -Bazaz Scale

Timeframe: Baseline to Day 1

Change in the Occurrence of Dysphagia -Bazaz Scale

Timeframe: Baseline to Day 2

Change in the Occurrence of Dysphagia -Bazaz Scale

Timeframe: Baseline to Week 1

Change in the Occurrence of Dysphagia -Bazaz Scale

Timeframe: Baseline to Week 2

Change in the Occurrence of Dysphagia -Bazaz Scale

Timeframe: Baseline to Month 3

Change in the Occurrence of Dysphagia -Bazaz Scale

Timeframe: Baseline to Month 12

Change in the Occurrence of Dysphagia -Bazaz Scale

Timeframe: Baseline to Month 1

Trial details

NCT IDNCT03711474

SponsorWest Virginia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-30

Results submitted2024-11-26

View on ClinicalTrials.gov More Dysphagia trials

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in the Occurrence of Dysphagia -Bazaz Scale

Timeframe: Baseline to Day 1

Change in the Occurrence of Dysphagia -Bazaz Scale

Timeframe: Baseline to Day 2

Change in the Occurrence of Dysphagia -Bazaz Scale

Timeframe: Baseline to Week 1

Change in the Occurrence of Dysphagia -Bazaz Scale

Timeframe: Baseline to Week 2

Change in the Occurrence of Dysphagia -Bazaz Scale

Timeframe: Baseline to Month 3

Change in the Occurrence of Dysphagia -Bazaz Scale

Timeframe: Baseline to Month 12

Change in the Occurrence of Dysphagia -Bazaz Scale

Timeframe: Baseline to Month 1