Dexamethasone for Swallowing Difficulty

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Swallowing DifficultyDexamethasone - Drug
Eligibility
18 - 80
All Sexes
What conditions do you have?
Select

Study Summary

This trial looks at whether a single dose of a steroid given intravenously can improve swallowing function after anterior cervical spine surgery, compared to a control group who received a saline solution.

Eligible Conditions
  • Swallowing Difficulty

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: one year

one year
Change in the occurrence of dysphagia and its associated complications

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Ondansetron
2%Cerebrospinal fluid leak
2%Deep Vein Thrombosis
2%Fever
This histogram enumerates side effects from a completed 2013 Phase 4 trial (NCT01474915) in the Ondansetron ARM group. Side effects include: Cerebrospinal fluid leak with 2%, Deep Vein Thrombosis with 2%, Fever with 2%.

Trial Design

2 Treatment Groups

Treatment 1; Dexamethasone
1 of 2
Treatment 0; Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

80 Total Participants · 2 Treatment Groups

Primary Treatment: Dexamethasone · Has Placebo Group · Phase 4

Treatment 1; Dexamethasone
Drug
Experimental Group · 1 Intervention: Dexamethasone · Intervention Types: Drug
Treatment 0; Placebo
Drug
PlaceboComparator Group · 1 Intervention: Saline · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: one year

Who is running the clinical trial?

West Virginia UniversityLead Sponsor
161 Previous Clinical Trials
50,357 Total Patients Enrolled
Scott Daffner, MDPrincipal Investigator - West Virginia University
Chestnut Ridge Hospital, Ruby Memorial Hospital, West Virginia Hospitals Inc
Jefferson Medical Coll-Thos Jefferson University (Medical School)
Thos Jefferson University Hospital (Residency)
1 Previous Clinical Trials
42 Total Patients Enrolled

Eligibility Criteria

Age 18 - 80 · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
indications, contraindications, and surgical technique The elective anterior approach to the subaxial cervical spine is a surgical technique that is used to treat disorders of the cervical spine
References