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Randomized Controlled Trials of the Effects of Decadron on Swallowing, Airway, and Arthrodesis

Prospective Randomized Controlled Trail of the Effects of Steroids on Swallowing, Airway and Arthrodesis Related to Myulti-Level Anterior Cervical Reconstruction

Status
UNKNOWN
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01065961
Enrollment
200
Registered
2010-02-10
Start date
2008-11-30
Completion date
2016-11-30
Last updated
2010-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Swallowing

Keywords

anterior, cervical, fusion, swallowing, Swallowing after anterior cervical discectomy and fusion, Bony fusion rates post anterior cervical discectomy and fusion

Brief summary

Anterior cervical discectomy and fusion with or without decompression is a well-established surgical treatment for spine patients with the appropriate indications. Anterior approach involves some retraction that affect the midline structures of the anterior neck. Irritation and swelling may result, leading to postoperative dysphagia and the less common but critically important occurrence of postoperative airway compromise. Steroids given intraoperatively may reduce the incidence of these adverse outcomes by reducing the degree of swelling within the anterior neck subsequent to local surgical tissue trauma. The investigators hypothesize that the use of steroids intraoperatively provides a significant benefit to the patient, in terms of reduced incidence of dysphagia and airway compromise.

Interventions

Decadron will be given at a dose of 0.2 mg/kg intraoperatively, followed by Decadron 4 mg. every 6 hours for 24 hours.

DRUGSaline

Placebo saline will be given intraoperatively as well as 4 doses every 6 hours for 24 hours.

Sponsors

Albany Medical College
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 18 years of age or greater * Cervical spondylosis requiring surgical treatment at 2 or more motion segments * Ventrally - approachable vertebral levels

Exclusion criteria

* Minors (under 18 years old) * Pregnant women * Patients currently taking steroids * Patients requiring surgical treatment at only one segment * Comatose or incapacitated patients who cannot consent to participate * Wards of the state * Persons with an allergy to dexamethasone or related drugs * Persons employed at Albany Medical Center

Design outcomes

Primary

MeasureTime frame
subjects will demonstrate good bony fusionone year

Countries

United States

Contacts

Primary ContactDarryl DiRisio, MD
dirisi@mail.amc.edu518 262-5088
Backup ContactMargaret Czerwinski, BSN, RN
czerwim@mail.amc.edu518 262-0034

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026