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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2008 by Albany Medical College
Sponsor:
Information provided by:
Albany Medical College
ClinicalTrials.gov Identifier:
NCT01065961
First received: February 9, 2010
Last updated: NA
Last verified: November 2008
History: No changes posted

February 9, 2010
February 9, 2010
November 2008
November 2016   (final data collection date for primary outcome measure)
subjects will demonstrate good bony fusion [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
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Not Provided
 
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

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Swallowing
  • 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.
  • Active Comparator: 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.
    Intervention: Drug: Decadron
  • Placebo Comparator: Saline
    subject will be given a blinded dose of placebo saline intraoperatively followed by placebo doses every 6 hours for 24 hours.
    Intervention: Drug: Saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
November 2016
November 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Darryl DiRisio, MD 518 262-5088 dirisi@mail.amc.edu
Contact: Margaret Czerwinski, BSN, RN 518 262-0034 czerwim@mail.amc.edu
United States
 
NCT01065961
D-01
No
Darryl DiRisio, MD, Albany Medical Center
Albany Medical College
Not Provided
Not Provided
Albany Medical College
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP