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N/A Completed N=74 Randomized Double-blind Prevention

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

OutcomeResultp-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
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. Informational only — not medical advice.

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