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

Status unconfirmed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Swallowing

In brief

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.

Key facts

Study ID: NCT01065961
Run by: Albany Medical College
People needed: 200
Starts: 2008-11-01
Expected to finish: 2016-11-01
Last updated by the study team: 2010-02-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

18 years of age or greater
Cervical spondylosis requiring surgical treatment at 2 or more motion segments
Ventrally - approachable vertebral levels

You may not qualify if…

Minors (under 18 years old)
Pregnant women
Patients currently taking steroids
Patients requiring surgical treatment at only one segment
Comatose or incapacitated patients who cannot consent to participate
Wards of the state
Persons with an allergy to dexamethasone or related drugs
Persons employed at Albany Medical Center

Where it is running

Albany Medical Center — Albany, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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