N/A N=74 Randomized Double-blind Prevention

Dysphagia Following Anterior Cervical Spine Surgery; Steroid vs Saline

Dysphagia

Bottom Line

View on ClinicalTrials.gov: NCT02416934 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2018

Primary outcome: Primary: Swallowing Difficulty — 16; 14; 5; 7 Participants — p=0.036

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Treatment 1; Dexamethasone (Drug); Treatment 0; Saline placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: West Virginia University
Primary completion: May 2016

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

Summary

This prospective, randomized, double blind, controlled study evaluates the effect of perioperative IV steroids 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 (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.