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

• Status: Unknown status
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Albany Medical College
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

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