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

Swallowing Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Swallowing

• NCT number: NCT01065961
• Study type: Interventional
• Source: Albany Medical College
• Contact: Darryl DiRisio, MD
• Phone: 518 262-5088
• Email: dirisi@mail.amc.edu
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: November 2008
• Completion date: November 2016