The Effect of Local Intraoperative Steroid Administration on Post-ACDF Dysphagia

Study Overview
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Brief Summary
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Few methods were available to determine which muscle groups are associated with PD in details in previous investigations. Local steroid administration has shown some effects on PD in a large number meta-analysis. In this study, we aimed to conduct a prospective randomized-double blinded study to exam the efficacy and the safety of the local steroid administration on ACDF patients by using high resolution impedance manometry in patients receiving ACDF.

Detailed Description
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Postoperative dysphagia (PD) is the most common complication after anterior cervical discectomy and fusion (ACDF). However, few methods were available to determine which muscle groups are associated with PD in details in previous investigations. Local steroid administration has shown some effects on PD in a large number meta-analysis. In this study, we aimed to conduct a prospective randomized-double blinded study to exam the efficacy and the safety of the local steroid administration on ACDF patients, and the also apply the high resolution impedance manometry (HRIM) on patients receiving ACDF for better delineation of the swallowing function. Pressure-flow analysis (PFA), derives pharyngeal pressure flow variables obtained from HRIM were used to analyze the mechanisms of PD.

Official Title
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The Effect of Local Intraoperative Steroid Administration on Post-ACDF Dysphagia - A Prospective Double-Blinded Study by High Resolution Impedance Manometry

Conditions
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Swallowing Function

Intervention / Treatment
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* Drug: steroid injection
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients undergoing elective anterior cervical spine surgery Exclusion Criteria: patients receiving spine surgery not at the first time patients with head and neck cancer patients receiving other surgeries at head and neck region patients had previous swallowing difficulty history

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: steroid group<br>patients receiving steroid injection for preventing postoperative dysphagia | Drug: steroid injection<br>* steroid injection at surgical location<br>|
| Placebo Comparator: placebo group<br>patients receiving saline injection for comparator | Drug: placebo<br>* saline injection at surgical location<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pharyngeal pressure | muscle power at pharyngeal region | preoperative, postoperative 1 month |