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

Study Overview
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Brief Summary
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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.

Official Title
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Prospective Randomized Controlled Trail of the Effects of Steroids on Swallowing, Airway and Arthrodesis Related to Myulti-Level Anterior Cervical Reconstruction

Conditions
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Swallowing

Intervention / Treatment
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* Drug: Decadron
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or greater Cervical spondylosis requiring surgical treatment at 2 or more motion segments Ventrally - approachable vertebral levels Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Decadron<br>Subject will be given Decadron 0.2mg/kg intraoperatively. This dose will be followed by 4 mg. every 6 hours for the first 24 hours. | Drug: Decadron<br>* Decadron will be given at a dose of 0.2 mg/kg intraoperatively, followed by Decadron 4 mg. every 6 hours for 24 hours.<br>|
| Placebo Comparator: Saline<br>subject will be given a blinded dose of placebo saline intraoperatively followed by placebo doses every 6 hours for 24 hours. | Drug: Saline<br>* Placebo saline will be given intraoperatively as well as 4 doses every 6 hours for 24 hours.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| subjects will demonstrate good bony fusion |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anterior, cervical, fusion, swallowing, Swallowing after anterior cervical discectomy and fusion, Bony fusion rates post anterior cervical discectomy and fusion