Dysphagia Following Anterior Cervical Spine Surgery; Single Dose Steroid vs Saline (DysDexVSSal)

Dysphagia Clinical Trial

Official title:

Impact of Single Dose Perioperative Steroids on Dysphagia Following Anterior Cervical Spine Surgery: A Randomized, Prospective, Double-Blind Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03711474
• Other study ID #: 1804077978
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: September 7, 2018
• Est. completion date: July 30, 2024

Study information

• Verified date: December 2023
• Source: West Virginia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This prospective, randomized, double blind, controlled study evaluates the effect of a single dose of perioperative IV steroid versus saline on swallowing after anterior cervical spine surgery

Description:

This investigation is a prospective, randomized, double-blind, controlled trial testing a single dose of peri-operative steroid versus saline and the effect on swallowing after anterior cervical spine surgery.

Swallowing symptoms will be measured using the patient reported Bazaz (Bazaz) scale, the EAT10 survey, and the Dysphagia Short Questionnaire (DSQ). Swallowing data will be obtained pre-operatively, one day and two days post-operatively and then one week, two weeks, four weeks, three months, six months, and one year post-operatively. Patient clinical outcomes will be captured using web-based progress reports. Patients will complete the Quality of Life (QoL-12), Neck Disability Index (NDI), and Visual Analog Scale (VAS) questionnaires electronically pre-operatively and at one year post-operatively. This outcome data will help us analyze the swallowing function or symptoms with the overall clinical course of the patients enrolled in this study.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: July 30, 2024
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Elective anterior approach to subaxial cervical spine (C3 - T1);

• ages 18-80

Exclusion Criteria:

• Traumatic or tumor etiologies

• undergoing anterior-posterior operations

• neoplastic, or infectious conditions requiring surgery

• a history of previous anterior cervical spine surgery

• any patient requiring a halo vest

• patients on chronic steroids

• patients remaining intubated post-operatively (please see more under risks below)

• less than 18 years of age

• pregnant women

• no phone

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia

Intervention

Drug:
• Dexamethasone
Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery
• Saline
Single dose of Dexamethasone IV or Saline IV given within the first hour of surgey

Locations

Country	Name	City	State
United States	West Virginia University Department of Orthopaedics	Morgantown	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
West Virginia University

Country where clinical trial is conducted

United States, 

References & Publications (6)

Bazaz R, Lee MJ, Yoo JU. Incidence of dysphagia after anterior cervical spine surgery: a prospective study. Spine (Phila Pa 1976). 2002 Nov 15;27(22):2453-8. doi: 10.1097/00007632-200211150-00007. — View Citation

Belafsky PC, Mouadeb DA, Rees CJ, Pryor JC, Postma GN, Allen J, Leonard RJ. Validity and reliability of the Eating Assessment Tool (EAT-10). Ann Otol Rhinol Laryngol. 2008 Dec;117(12):919-24. doi: 10.1177/000348940811701210. — View Citation

Jeyamohan SB, Kenning TJ, Petronis KA, Feustel PJ, Drazin D, DiRisio DJ. Effect of steroid use in anterior cervical discectomy and fusion: a randomized controlled trial. J Neurosurg Spine. 2015 Aug;23(2):137-43. doi: 10.3171/2014.12.SPINE14477. Epub 2015 May 1. — View Citation

Leonard R, Belafsky P. Dysphagia following cervical spine surgery with anterior instrumentation: evidence from fluoroscopic swallow studies. Spine (Phila Pa 1976). 2011 Dec 1;36(25):2217-23. doi: 10.1097/BRS.0b013e318205a1a7. — View Citation

Skeppholm M, Ingebro C, Engstrom T, Olerud C. The Dysphagia Short Questionnaire: an instrument for evaluation of dysphagia: a validation study with 12 months' follow-up after anterior cervical spine surgery. Spine (Phila Pa 1976). 2012 May 15;37(11):996-1002. doi: 10.1097/BRS.0b013e31823a7a5b. — View Citation

Song KJ, Lee SK, Ko JH, Yoo MJ, Kim DY, Lee KB. The clinical efficacy of short-term steroid treatment in multilevel anterior cervical arthrodesis. Spine J. 2014 Dec 1;14(12):2954-8. doi: 10.1016/j.spinee.2014.06.005. Epub 2014 Jun 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the occurrence of dysphagia and its associated complications	Number of Participants With Treatment-Related dysphagia as Assessed by Change From Baseline Scores on the Bazaz, Dysphagia Short Questionnaire, and EAT 10 at 1 year	one year