Effects of 3% Sodium Chloride on Post-operative Dysphagia Following Anterior Cervical Spine Surgery

Study Overview
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Brief Summary
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Post-operative dysphagia is a significant issue following anterior cervical spine surgery. The investigators are studying the effects of perioperative 3% sodium chloride, given over a period of 24 hours, on post-operative dysphagia. The goal is to reduce the incidence and severity of post-operative dysphagia.

Detailed Description
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Based on a priori analysis the investigators will need 100 subjects in a placebo arm (normal saline) and 100 subjects in a treatment arm (3% sodium chloride), for a total of 200 patients. This study will be conducted on healthy subjects with normal renal function undergoing anterior cervical discectomy and fusion for degenerative indications only. Subjects will be randomized to the treatment or placebo arm (which will be double blinded). Subjects in the treatment arm will begin to receive intravenous 3% sodium chloride before the incision is made. The solution will be given at a rate of 10 cc/hour over a period of 24 hours. Baseline, post-operative, and delayed post-operative dysphagia surveys will be administered either in person or by telephone. The investigators hope to decrease the incidence and severity of post-operative dysphagia.

Official Title
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The Effects of 3% Sodium Chloride on Post-operative Dysphagia in Patients Undergoing Anterior Cervical Discectomy and Fusion: a Prospective, Randomized Double-blind Trial

Conditions
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Dysphagia

Intervention / Treatment
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* Drug: 3% Sodium Chloride
* Drug: Normal Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients undergoing anterior cervical discectomy and fusion for degenerative indications Exclusion Criteria: history of cervical trauma baseline dysphagia age less than 18 years old history of previous anterior neck surgery Creatinine clearance less than 30 Creatinine greater than 1.0 baseline sodium greater than 145 patients with known electrolyte abnormalities congestive heart failure

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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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: There is no effective treatment for post-operative dysphagia. Thus crossover is not expected.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3% sodium chloride<br>Subjects in this group will receive 3% sodium chloride over a period of 24 hours at a rate of 10 cc/hour beginning immediately prior to incision. | Drug: 3% Sodium Chloride<br>* 3% sodium chloride will be given intravenously at a rate of 10 cc/hour over a period of 24 hours beginning immediately prior to incision.<br>|
| Sham Comparator: Normal Saline<br>This group will receive normal saline over a period of 24 hours at a rate of 10 cc/hour beginning immediately prior to incision. | Drug: Normal Saline<br>* Normal Saline will be given intravenously at a rate of 10 cc/hour over a period of 24 hours beginning immediately prior to incision.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative dysphagia | Dysphagia as assessed by the Bazaz Dysphagia Score. The Bazaz score grades dysphagia based on a short questionnaire as none, mild, moderate, and severe. | Change in dysphagia scores will be assessed from pre-operative baseline value to: post-operative day one value, 2 week value, 6 week value, and 12 week value. |