Effect of Intravenous Corticosteroid Injections on Dysphagia After Cervical Spine Surgery

NYU Langone Health

Status and phase: Terminated; Phase 3

Conditions: Dysphagia After Anterior Cervical Decompression and Fusion of the Spine

Treatments: Other: Saline; Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT02266797

13-00108

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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4 participants in 2 patient groups, including a placebo group

Dexamethasone

Active Comparator group

Description:

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.

Treatment:

Drug: Dexamethasone

Saline

Placebo Comparator group

Description:

Subject will receive doses of intravenous physiological saline solution.

Treatment:

Other: Saline