N/A
Completed N=74
Dysphagia Following Anterior Cervical Spine Surgery; Steroid vs Saline
Source: ClinicalTrials.gov NCT02416934 ↗Enrolled (actual)
74
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcomePrimary: Swallowing Difficulty — 16; 14; 5; 7 Participants — p=0.036
Summary
This prospective, randomized, double blind, controlled study evaluates the effect of perioperative IV steroids versus saline on swallowing after anterior cervical spine surgery.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Swallowing Difficulty |
16; 14; 5; 7; 24; 28 | 0.036 sig |
| SECONDARY Change in Quality of Life |
-6.1208; -7.9082 | <.05 sig |
| SECONDARY Fusion Rate Steroid vs Placebo |
13; 19; 20; 11; 0; 1 | .375 |
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
Data sourced from ClinicalTrials.gov (NCT02416934). 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. Informational only — not medical advice.