Effect of Intravenous Corticosteroid Injections on Dysphagia After Cervical Spine Surgery

NCT02266797 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2018-10-25

Study results available
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Summary

This is a randomized, double-blind, placebo-controlled study to examine the effect of local intravenous steroids following anterior cervical spine surgery on the development of dysphagia in patients.

Conditions

  • Dysphagia After Anterior Cervical Decompression and Fusion of the Spine

Interventions

DRUG

Dexamethasone

The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose.

OTHER

Saline

The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2015-09-01
Completion
2015-09-01

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02266797 on ClinicalTrials.gov