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

This study is currently recruiting participants.
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
  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
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Albany Medical College:

Primary Outcome Measures:
  • subjects will demonstrate good bony fusion [ Time Frame: one year ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Darryl DiRisio, MD, Albany Medical Center
ClinicalTrials.gov Identifier: NCT01065961     History of Changes
Other Study ID Numbers: D-01
Study First Received: February 9, 2010
Last Updated: February 9, 2010
Health Authority: United States: Food and Drug Administration

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
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013