Effect of Intravenous Corticosteroid Injections on Dysphagia After Anterior Cervical Spine Surgery: a Randomized, Double-blind, Placebo-controlled Study
Overview
- Phase
- Phase 3
- Intervention
- Dexamethasone
- Conditions
- Dysphagia After Anterior Cervical Decompression and Fusion of the Spine
- Sponsor
- NYU Langone Health
- Enrollment
- 4
- Locations
- 3
- Primary Endpoint
- Intravenous Corticosteroids Effect on Post-operative Dysphagia
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Dexamethasone
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.
Intervention: Dexamethasone
Saline
Subject will receive doses of intravenous physiological saline solution.
Intervention: Saline
Outcomes
Primary Outcomes
Intravenous Corticosteroids Effect on Post-operative Dysphagia
Time Frame: 12 months
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.
The Correlation Between Radiographic Data and the Extent of Dysphagia in Patients.
Time Frame: 12 months
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.
Secondary Outcomes
- Examine the Impact of Dexamethasone on Radicular Pain.(12 months)
- Examine the Impact of Dexamethasone on the Development of Postoperative Nausea.(Immediate post-operatively)
- Examine Whether Intravenous Steroids Affect the Outcomes of Surgery, for Example, Fusion Rates.(12 months)
- The Efficacy of Intravenous Steroids on Aspiration Rates of Patients Undergoing Anterior Cervical Spine Surgery.(12 months)