Recruiting

Phase 1

Phase 2

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

Sponsor:

Albany Medical College

Code:

NCT01065961

Conditions

Swallowing

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Decadron

Saline

Study Details

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.

Conditions

Swallowing

Study ID

NCT01065961

Start date

Nov, 2008

Status verified date

Nov, 2008

Completion date

Nov, 2016

Anticipated

Primary completion date

Nov, 2016

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

placebo comparator: Saline

subject will be given a blinded dose of placebo saline intraoperatively followed by placebo doses every 6 hours for 24 hours.

Interventions

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.

Saline

Placebo saline will be given intraoperatively as well as 4 doses every 6 hours for 24 hours.

Primary outcome measure

subjects will demonstrate good bony fusion [ Time Frame: one year ]

Central Contacts and Locations

Central contacts

Darryl DiRisio, MD

518 262-5088 dirisi@mail.amc.edu

Margaret Czerwinski, BSN, RN

518 262-0034 czerwim@mail.amc.edu

Locations

Albany Medical Center

Recruiting

Albany, New York, United States, 12208

More Information

Sponsor

Albany Medical College

Last update posted

Feb 10, 2010

Last verified

Nov, 2008

Keywords

anterior
cervical
fusion
swallowing
Swallowing after anterior cervical discectomy and fusion
Bony fusion rates post anterior cervical discectomy and fusion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Albany Medical College on 2010-02-10.