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Randomized Controlled Trials of the Effects of Decadron on Swallowing, Airway, and Arthrodesis

NCT01065961 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2010-02-10

No results posted yet for this study

Summary

Anterior cervical discectomy and fusion with or without decompression is a well-established surgical treatment for spine patients with the appropriate indications. Anterior approach involves some retraction that affect the midline structures of the anterior neck. Irritation and swelling may result, leading to postoperative dysphagia and the less common but critically important occurrence of postoperative airway compromise. Steroids given intraoperatively may reduce the incidence of these adverse outcomes by reducing the degree of swelling within the anterior neck subsequent to local surgical tissue trauma.

The investigators hypothesize that the use of steroids intraoperatively provides a significant benefit to the patient, in terms of reduced incidence of dysphagia and airway compromise.

Conditions

  • Swallowing

Interventions

DRUG

Decadron

Decadron will be given at a dose of 0.2 mg/kg intraoperatively, followed by Decadron 4 mg. every 6 hours for 24 hours.

DRUG

Saline

Placebo saline will be given intraoperatively as well as 4 doses every 6 hours for 24 hours.

Sponsors & Collaborators

  • Albany Medical College

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • United States

Study Locations

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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 NCT01065961 on ClinicalTrials.gov