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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2008 by Albany Medical College.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01065961
First Posted: February 10, 2010
Last Update Posted: February 10, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Albany Medical College
  Purpose

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 Intervention Phase
Swallowing Drug: Decadron Drug: Saline Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Albany Medical College:

Primary Outcome Measures:
  • subjects will demonstrate good bony fusion [ Time Frame: one year ]

Estimated Enrollment: 200
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)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01065961


Contacts
Contact: Darryl DiRisio, MD 518 262-5088 dirisi@mail.amc.edu
Contact: Margaret Czerwinski, BSN, RN 518 262-0034 czerwim@mail.amc.edu

Locations
United States, New York
Albany Medical Center Recruiting
Albany, New York, United States, 12208
Sponsors and Collaborators
Albany Medical College
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Darryl DiRisio, MD, Albany Medical Center
ClinicalTrials.gov Identifier: NCT01065961     History of Changes
Other Study ID Numbers: D-01
First Submitted: February 9, 2010
First Posted: February 10, 2010
Last Update Posted: February 10, 2010
Last Verified: November 2008

Keywords provided by Albany Medical College:
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 acetate
Dexamethasone
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action