Effect of Intravenous Corticosteroid Injections on Dysphagia After Cervical Spine Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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The purpose of this randomized, double-blind, placebo-controlled study is to examine the effect of local intravenous steroids following anterior cervical spine surgery on the development of dysphagia in patients. This study aims to investigate if there is a difference in the efficacy of intravenous steroids compared to a placebo of physiological saline for patients undergoing anterior cervical spine surgery. Furthermore, this study aims to investigate the correlation between radiographic measurements of soft tissue swelling and the severity of dysphagia for patients. Finally, this study aims to examine the impact of intravenous steroids on nausea and radicular pain in patients. Secondary outcome measures will include patient focused outcomes questionnaires, pain medication requirements, and fusion rates.

Official Title
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Effect of Intravenous Corticosteroid Injections on Dysphagia After Anterior Cervical Spine Surgery: a Randomized, Double-blind, Placebo-controlled Study

Conditions
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Dysphagia After Anterior Cervical Decompression and Fusion of the Spine

Intervention / Treatment
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* Drug: Dexamethasone
* Other: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subjects included in the study are patients undergoing an anterior cervical spine procedure. Exclusion Criteria: Patients with greater than ASA grade II will be excluded. Patients with non-degenerative conditions, such as trauma, tumors, infection, radiation, and diabetes will be excluded. Patients with posterior procedures will be excluded. Patients with clinical pre-operative dysphagia, indicated by a score of 3 or higher on the EAT-10 questionnaire,19 will also be excluded. Patients who are pregnant will be excluded from this study.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexamethasone<br>Subject will receive doses of intravenous dexamethasone, a corticosteroid. 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. | Drug: Dexamethasone<br>* 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.<br>|
| Placebo Comparator: Saline<br>Subject will receive doses of intravenous physiological saline solution. | Other: Saline<br>* The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intravenous Corticosteroids Effect on Post-operative Dysphagia | The severity of dysphagia will be evaluated by dysphagia questionnaires and a two week postoperative swallow evaluation by a licensed swallowing expert. If recommended by the swallow evaluation, a videofluoroscopic swallow study (VFSS) will be performed to further evaluate the severity of dysphagia. | 12 months | 
| The Correlation Between Radiographic Data and the Extent of Dysphagia in Patients. | Soft-tissue swelling will be measured by the anterior cervical soft-tissue shadow width on lateral cervical radiographs. The extent of dysphagia will be evaluated by the dysphagia questionnaires, the swallow evaluation, and the VFSS, if necessary. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Efficacy of Intravenous Steroids on Aspiration Rates of Patients Undergoing Anterior Cervical Spine Surgery. | Aspiration rates will be evaluated by the percentage of patients in each group with post-operative aspiration. | 12 months | 
| Examine the Impact of Dexamethasone on the Development of Postoperative Nausea. | This will be quantified by the visual analogue scale (VAS) questionnaire for nausea and measuring the number of vomiting episodes following surgery. | Immediate post-operatively | 
| Examine the Impact of Dexamethasone on Radicular Pain. | This will be quantified by the NDI questionnaire and VAS questionnaire for neck pain and arm pain. | 12 months | 
| Examine Whether Intravenous Steroids Affect the Outcomes of Surgery, for Example, Fusion Rates. | The outcomes of surgery will be examined through the 1 year post-operative appointment. | 12 months |