Randomized Controlled Trials of the Effects of Decadron on Swallowing, Airway, and Arthrodesis
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Prospective Randomized Controlled Trail of the Effects of Steroids on Swallowing, Airway and Arthrodesis Related to Myulti-Level Anterior Cervical Reconstruction|
- subjects will demonstrate good bony fusion [ Time Frame: one year ] [ Designated as safety issue: No ]
|Study Start Date:||November 2008|
|Estimated Study Completion Date:||November 2016|
|Estimated Primary Completion Date:||November 2016 (Final data collection date for primary outcome measure)|
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.
Decadron will be given at a dose of 0.2 mg/kg intraoperatively, followed by Decadron 4 mg. every 6 hours for 24 hours.
Placebo Comparator: Saline
subject will be given a blinded dose of placebo saline intraoperatively followed by placebo doses every 6 hours for 24 hours.
Placebo saline will be given intraoperatively as well as 4 doses every 6 hours for 24 hours.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01065961
|Contact: Darryl DiRisio, MD||518 email@example.com|
|Contact: Margaret Czerwinski, BSN, RN||518 firstname.lastname@example.org|
|United States, New York|
|Albany Medical Center||Recruiting|
|Albany, New York, United States, 12208|