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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
4
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.
The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose.
Center for Musculoskeletal Care (CMC)
New York, New York, United States
NYU Langone Medical Center
New York, New York, United States
NY Spine Institute
Westbury, New York, United States
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.
Time frame: 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.
Time frame: 12 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 12 months