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

Phase 1

• Conditions: Swallowing
• Interventions: Drug: Saline; Drug: Decadron

• Registration Number: NCT01065961
• Lead Sponsor: Albany Medical College

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2008-11
• Study Start: 2008-11
• Study First Submitted: 2010-02-09
• Study First Submitted QC: 2010-02-09
• Last Update Submitted: 2010-02-09
• Study First Posted: 2010-02-10
• Last Update Posted: 2010-02-10
• Primary Completion: 2016-11
• Study Completion: 2016-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
subjects will demonstrate good bony fusion	one year

Trial Locations

Locations (1)

Albany Medical Center; 🇺🇸 Albany, New York, United States