Effect of Intravenous Corticosteroid Injections on Dysphagia After Cervical Spine Surgery

Phase 3

Terminated

• Conditions: Dysphagia After Anterior Cervical Decompression and Fusion of the Spine
• Interventions: Other: Saline; Drug: Dexamethasone

• Registration Number: NCT02266797
• Lead Sponsor: NYU Langone Health

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2014-10-02
• Study First Submitted QC: 2014-10-13
• Study First Posted: 2014-10-17
• Primary Completion: 2015-09-01
• Study Completion: 2015-09-01
• Results First Submitted: 2015-10-30
• Results First Submitted QC: 2016-02-16
• Results First Posted: 2016-03-14
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-26
• Last Update Posted: 2018-10-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

• The subjects included in the study are patients undergoing an anterior cervical spine procedure.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline	Saline	Subject will receive doses of intravenous physiological saline solution.
Dexamethasone	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.

Primary Outcome Measures

Name	Time	Method
Intravenous Corticosteroids Effect on Post-operative Dysphagia	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.	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 Outcome Measures

Name	Time	Method
Examine the Impact of Dexamethasone on Radicular Pain.	12 months	This will be quantified by the NDI questionnaire and VAS questionnaire for neck pain and arm pain.
Examine the Impact of Dexamethasone on the Development of Postoperative Nausea.	Immediate post-operatively	This will be quantified by the visual analogue scale (VAS) questionnaire for nausea and measuring the number of vomiting episodes following surgery.
Examine Whether Intravenous Steroids Affect the Outcomes of Surgery, for Example, Fusion Rates.	12 months	The outcomes of surgery will be examined through the 1 year post-operative appointment.
The Efficacy of Intravenous Steroids on Aspiration Rates of Patients Undergoing Anterior Cervical Spine Surgery.	12 months	Aspiration rates will be evaluated by the percentage of patients in each group with post-operative aspiration.

Trial Locations

Locations (3)

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