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
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2008
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 9, 2010
CompletedFirst Posted
Study publicly available on registry
February 10, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedFebruary 10, 2010
November 1, 2008
8 years
February 9, 2010
February 9, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
subjects will demonstrate good bony fusion
one year
Study Arms (2)
Decadron
ACTIVE COMPARATORSubject will be given Decadron 0.2mg/kg intraoperatively. This dose will be followed by 4 mg. every 6 hours for the first 24 hours.
Saline
PLACEBO COMPARATORsubject will be given a blinded dose of placebo saline intraoperatively followed by placebo doses every 6 hours for 24 hours.
Interventions
Eligibility Criteria
You may qualify if:
- years of age or greater
- Cervical spondylosis requiring surgical treatment at 2 or more motion segments
- Ventrally - approachable vertebral levels
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Albany Medical Center
Albany, New York, 12208, United States
Related Publications (1)
Jeyamohan SB, Kenning TJ, Petronis KA, Feustel PJ, Drazin D, DiRisio DJ. Effect of steroid use in anterior cervical discectomy and fusion: a randomized controlled trial. J Neurosurg Spine. 2015 Aug;23(2):137-43. doi: 10.3171/2014.12.SPINE14477. Epub 2015 May 1.
PMID: 25932600DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 9, 2010
First Posted
February 10, 2010
Study Start
November 1, 2008
Primary Completion
November 1, 2016
Study Completion
November 1, 2016
Last Updated
February 10, 2010
Record last verified: 2008-11