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

• Sponsor: Albany Medical College (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01065961
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Duration (Months): 96
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Swallowing	Drug: Decadron; Drug: Saline	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, 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
• Study Start Date: Nov 1, 2008
• Anticipated Primary Completion Date: Nov 1, 2016
• Anticipated Study Completion Date: Nov 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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.	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.
Placebo Comparator: Saline subject will be given a blinded dose of placebo saline intraoperatively followed by placebo doses 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.

Outcome Measures

Primary Outcome Measures

1. subjects will demonstrate good bony fusion [one year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Albany Medical Center	Albany	New York	United States	12208

Sponsors and Collaborators

• Albany Medical College

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01065961
• Other Study ID Numbers: D-01
• First Posted: Feb 10, 2010
• Last Update Posted: Feb 10, 2010
• Last Verified: Nov 1, 2008

• Keywords provided by , ,: anterior; cervical; fusion; swallowing; Swallowing after anterior cervical discectomy and fusion; Bony fusion rates post anterior cervical discectomy and fusion
• Additional relevant MeSH terms: Dexamethasone; Dexamethasone acetate; BB 1101

Study Results

No Results Posted as of Feb 10, 2010