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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01065961
• Other study ID #: D-01
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: February 9, 2010
• Last updated: February 9, 2010
• Start date: November 2008
• Est. completion date: November 2016

Study information

• Verified date: November 2008
• Source: Albany Medical College
• Contact: Darryl DiRisio, MD
• Phone: 518 262-5088
• Email: dirisi[@]mail.amc.edu
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Swallowing

Intervention

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.
• Saline
Placebo saline will be given intraoperatively as well as 4 doses every 6 hours for 24 hours.

Locations

Country	Name	City	State
United States	Albany Medical Center	Albany	New York

Sponsors (1)

Lead Sponsor	Collaborator
Albany Medical College

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	subjects will demonstrate good bony fusion		one year	No