Dysphagia Following Anterior Cervical Spine Surgery; Single Dose Steroid vs Saline (DysDexVSSal)

Study Overview
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Brief Summary
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This prospective, randomized, double blind, controlled study evaluates the effect of a single dose of perioperative IV steroid versus saline on swallowing after anterior cervical spine surgery

Detailed Description
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This investigation is a prospective, randomized, double-blind, controlled trial testing a single dose of peri-operative steroid versus saline and the effect on swallowing after anterior cervical spine surgery. Swallowing symptoms will be measured using the patient reported Bazaz (Bazaz) scale, the EAT10 survey, and the Dysphagia Short Questionnaire (DSQ). Swallowing data will be obtained pre-operatively, one day and two days post-operatively and then one week, two weeks, four weeks, three months, six months, and one year post-operatively. Patient clinical outcomes will be captured using web-based progress reports. Patients will complete the Quality of Life (QoL-12), Neck Disability Index (NDI), and Visual Analog Scale (VAS) questionnaires electronically pre-operatively and at one year post-operatively. This outcome data will help us analyze the swallowing function or symptoms with the overall clinical course of the patients enrolled in this study.

Official Title
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Impact of Single Dose Perioperative Steroids on Dysphagia Following Anterior Cervical Spine Surgery: A Randomized, Prospective, Double-Blind Study

Conditions
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Dysphagia

Intervention / Treatment
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* Drug: Dexamethasone
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elective anterior approach to subaxial cervical spine (C3 - T1); ages 18-80 Exclusion Criteria: Traumatic or tumor etiologies undergoing anterior-posterior operations neoplastic, or infectious conditions requiring surgery a history of previous anterior cervical spine surgery any patient requiring a halo vest patients on chronic steroids patients remaining intubated post-operatively (please see more under risks below) less than 18 years of age pregnant women no phone

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized; double blinded (participant and investigator)
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment 1; Dexamethasone<br>Drug: Treatment 1; Dexamethasone. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10 and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery. Patients will be randomized to either the single dose steroid administration group or the single dose saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of incision. | Drug: Dexamethasone<br>* Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery<br>* Other names: Steroid;|
| Placebo Comparator: Treatment 0; Placebo<br>Drug: Treatment 0; Saline placebo. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10, and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery. Patients will be randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of the incision. | Drug: Saline<br>* Single dose of Dexamethasone IV or Saline IV given within the first hour of surgey<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the occurrence of dysphagia and its associated complications | Number of Participants With Treatment-Related dysphagia as Assessed by Change From Baseline Scores on the Bazaz, Dysphagia Short Questionnaire, and EAT 10 at 1 year | one year |