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

Albany Medical College

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Swallowing

Treatments: Drug: Saline; Drug: Decadron

Study type: Interventional

Funder types: Other

Identifiers

NCT01065961

D-01

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups, including a placebo group

Decadron

Active Comparator group

Description:

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.

Treatment:

Drug: Decadron

Saline

Placebo Comparator group

Description:

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

Treatment:

Drug: Saline