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Clinical Trials/NCT01065961
NCT01065961
Unknown
Phase 1

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

Albany Medical College1 site in 1 country200 target enrollmentNovember 2008
ConditionsSwallowing
InterventionsSalineDecadron

Overview

Phase
Phase 1
Intervention
Saline
Conditions
Swallowing
Sponsor
Albany Medical College
Enrollment
200
Locations
1
Primary Endpoint
subjects will demonstrate good bony fusion
Last Updated
16 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2008
End Date
November 2016
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

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

Arms & Interventions

Saline

subject will be given a blinded dose of placebo saline intraoperatively followed by placebo doses every 6 hours for 24 hours.

Intervention: Saline

Decadron

Subject will be given Decadron 0.2mg/kg intraoperatively. This dose will be followed by 4 mg. every 6 hours for the first 24 hours.

Intervention: Decadron

Outcomes

Primary Outcomes

subjects will demonstrate good bony fusion

Time Frame: one year

Study Sites (1)

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