NCT01065961

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
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Albany Medical College · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Swallowing

Interventions

Type	Name	Description
DRUG	Decadron	Decadron will be given at a dose of 0.2 mg/kg intraoperatively, followed by Decadron 4 mg. every 6 hours for 24 hours.
DRUG	Saline	Placebo saline will be given intraoperatively as well as 4 doses every 6 hours for 24 hours.

Timeline

• Start date: 2008-11-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2010-02-10
• Last updated: 2010-02-10

Locations

1 site across 1 country: United States