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Completed

NCT Number: NCT03711474

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

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

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Key information

Conditions

Dysphagia Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

West Virginia University Department of Orthopaedics

Morgantown, West Virginia, 26506, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery

Other names: Steroid

Saline

Drug

Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery

Primary outcomes

  1. Change in the Occurrence of Dysphagia -Bazaz Scale

    Time frame: Baseline to Day 1

    Change from baseline scores on the dysphagia Bazaz Scale. • Bazaz grading system is designed for the evaluation of swallowing difficulty after cervical surgery. The patients are graded on a scale as having None (0), Mild (1), Moderate (2), or Severe (3) dysphagia based on their symptoms. None (0) or Mild (1) dysphagia is considered to be a better outcome.

  2. Change in the Occurrence of Dysphagia -Bazaz Scale

    Time frame: Baseline to Day 2

    Change from baseline scores on the dysphagia Bazaz Scale. • Bazaz grading system is designed for the evaluation of swallowing difficulty after cervical surgery. The patients are graded on a scale as having None (0), Mild (1), Moderate (2), or Severe (3) dysphagia based on their symptoms. None (0) or Mild (1) dysphagia is considered to be a better outcome.

  3. Change in the Occurrence of Dysphagia -Bazaz Scale

    Time frame: Baseline to Week 1

    Change from baseline scores on the dysphagia Bazaz Scale. • Bazaz grading system is designed for the evaluation of swallowing difficulty after cervical surgery. The patients are graded on a scale as having None (0), Mild (1), Moderate (2), or Severe (3) dysphagia based on their symptoms. None (0) or Mild (1) dysphagia is considered to be a better outcome.

  4. Change in the Occurrence of Dysphagia -Bazaz Scale

    Time frame: Baseline to Week 2

    Change from baseline scores on the dysphagia Bazaz Scale. • Bazaz grading system is designed for the evaluation of swallowing difficulty after cervical surgery. The patients are graded on a scale as having None (0), Mild (1), Moderate (2), or Severe (3) dysphagia based on their symptoms. None (0) or Mild (1) dysphagia is considered to be a better outcome.

  5. Change in the Occurrence of Dysphagia -Bazaz Scale

    Time frame: Baseline to Month 3

    Change from baseline scores on the dysphagia Bazaz Scale. • Bazaz grading system is designed for the evaluation of swallowing difficulty after cervical surgery. The patients are graded on a scale as having None (0), Mild (1), Moderate (2), or Severe (3) dysphagia based on their symptoms. None (0) or Mild (1) dysphagia is considered to be a better outcome.

  6. Change in the Occurrence of Dysphagia -Bazaz Scale

    Time frame: Baseline to Month 12

    Change from baseline scores on the dysphagia Bazaz Scale. • Bazaz grading system is designed for the evaluation of swallowing difficulty after cervical surgery. The patients are graded on a scale as having None (0), Mild (1), Moderate (2), or Severe (3) dysphagia based on their symptoms. None (0) or Mild (1) dysphagia is considered to be a better outcome.

  7. Change in the Occurrence of Dysphagia -Bazaz Scale

    Time frame: Baseline to Month 1

    Change from baseline scores on the dysphagia Bazaz Scale. • Bazaz grading system is designed for the evaluation of swallowing difficulty after cervical surgery. The patients are graded on a scale as having None (0), Mild (1), Moderate (2), or Severe (3) dysphagia based on their symptoms. None (0) or Mild (1) dysphagia is considered to be a better outcome.

  8. Change in the Occurrence of Dysphagia -Bazaz Scale

    Time frame: Baseline to Month 6

    Change from baseline scores on the dysphagia Bazaz Scale. • Bazaz grading system is designed for the evaluation of swallowing difficulty after cervical surgery. The patients are graded on a scale as having None (0), Mild (1), Moderate (2), or Severe (3) dysphagia based on their symptoms. None (0) or Mild (1) dysphagia is considered to be a better outcome.

  9. Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ).

    Time frame: Baseline to Day 1

    Change from baseline scores on the dysphagia DSQ. Dysphagia Short Questionnaire (DSQ) is designed for the evaluation of swallowing difficulty after cervical surgery. Each question is given a weighted number from 0 points up to 4 points. The total score is calculated by summing up the points given for each item with the total range being from 0 points to a maximum of 18 points. The lower scores represent milder symptoms, and higher scores represent worse symptoms.

  10. Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ).

    Time frame: Baseline to Day 2

    Change from baseline scores on the dysphagia DSQ. • Dysphagia Short Questionnaire (DSQ) is designed for the evaluation of swallowing difficulty after cervical surgery. Each question is given a weighted number from 0 points up to 4 points. The total score is calculated by summing up the points given for each item with the total range being from 0 points to a maximum of 18 points. The lower scores represent milder symptoms, and higher scores represent worse symptoms.

  11. Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ).

    Time frame: Baseline to Week 1

    Change from baseline scores on the dysphagia DSQ. Dysphagia Short Questionnaire (DSQ) is designed for the evaluation of swallowing difficulty after cervical surgery. Each question is given a weighted number from 0 points up to 4 points. The total score is calculated by summing up the points given for each item with the total range being from 0 points to a maximum of 18 points. The lower scores represent milder symptoms, and higher scores represent worse symptoms.

  12. Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ).

    Time frame: Baseline to Week 2

    Change from baseline scores on the dysphagia DSQ.• Dysphagia Short Questionnaire (DSQ) is designed for the evaluation of swallowing difficulty after cervical surgery. Each question is given a weighted number from 0 points up to 4 points. The total score is calculated by summing up the points given for each item with the total range being from 0 points to a maximum of 18 points. The lower scores represent milder symptoms, and higher scores represent worse symptoms.

  13. Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ).

    Time frame: Baseline to Month 1

    Change from baseline scores on the dysphagia DSQ.• Dysphagia Short Questionnaire (DSQ) is designed for the evaluation of swallowing difficulty after cervical surgery. Each question is given a weighted number from 0 points up to 4 points. The total score is calculated by summing up the points given for each item with the total range being from 0 points to a maximum of 18 points. The lower scores represent milder symptoms, and higher scores represent worse symptoms.

  14. Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ).

    Time frame: Baseline to Month 3

    Change from baseline scores on the dysphagia DSQ. • Dysphagia Short Questionnaire (DSQ) is designed for the evaluation of swallowing difficulty after cervical surgery. Each question is given a weighted number from 0 points up to 4 points. The total score is calculated by summing up the points given for each item with the total range being from 0 points to a maximum of 18 points. The lower scores represent milder symptoms, and higher scores represent worse symptoms.

  15. Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ).

    Time frame: Baseline to Month 6

    Change from baseline scores on the dysphagia DSQ.• Dysphagia Short Questionnaire (DSQ) is designed for the evaluation of swallowing difficulty after cervical surgery. Each question is given a weighted number from 0 points up to 4 points. The total score is calculated by summing up the points given for each item with the total range being from 0 points to a maximum of 18 points. The lower scores represent milder symptoms, and higher scores represent worse symptoms.

  16. Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ).

    Time frame: Baseline to Month 12

    Change from baseline scores on the dysphagia DSQ. • Dysphagia Short Questionnaire (DSQ) is designed for the evaluation of swallowing difficulty after cervical surgery. Each question is given a weighted number from 0 points up to 4 points. The total score is calculated by summing up the points given for each item with the total range being from 0 points to a maximum of 18 points. The lower scores represent milder symptoms, and higher scores represent worse symptoms.

  17. Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening.

    Time frame: Baseline to Day 1

    Change from baseline scores on the dysphagia EAT 10 Screening is a screening tool to help measure swallowing difficulties, dysphagia severity & monitor treatment response. It is a likert scale from 0-4, with a maximum score of 40. If the EAT-10 score is 3 or higher, this could indicate problems swallowing efficiently or safely.

  18. Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening.

    Time frame: Baseline to Day 2

    Change from baseline scores on the dysphagia EAT 10 Screening is a screening tool to help measure swallowing difficulties, dysphagia severity & monitor treatment response. It is a likert scale from 0-4, with a maximum score of 40. If the EAT-10 score is 3 or higher, this could indicate problems swallowing efficiently or safely.

  19. Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening.

    Time frame: Baseline to Week 1

    Change from baseline scores on the dysphagia EAT 10 Screening is a screening tool to help measure swallowing difficulties, dysphagia severity & monitor treatment response. It is a likert scale from 0-4, with a maximum score of 40. If the EAT-10 score is 3 or higher, this could indicate problems swallowing efficiently or safely.

  20. Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening.

    Time frame: Baseline to Week 2

    Change from baseline scores on the dysphagia EAT 10 Screening is a screening tool to help measure swallowing difficulties, dysphagia severity & monitor treatment response. It is a likert scale from 0-4, with a maximum score of 40. If the EAT-10 score is 3 or higher, this could indicate problems swallowing efficiently or safely.

  21. Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening.

    Time frame: Baseline to Month 1

    Change from baseline scores on the dysphagia EAT 10 Screening is a screening tool to help measure swallowing difficulties, dysphagia severity & monitor treatment response. It is a likert scale from 0-4, with a maximum score of 40. If the EAT-10 score is 3 or higher, this could indicate problems swallowing efficiently or safely.

  22. Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening.

    Time frame: Baseline to Month 3

    Change from baseline scores on the dysphagia EAT 10 Screening is a screening tool to help measure swallowing difficulties, dysphagia severity & monitor treatment response. It is a likert scale from 0-4, with a maximum score of 40. If the EAT-10 score is 3 or higher, this could indicate problems swallowing efficiently or safely.

  23. Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening.

    Time frame: Baseline to Month 6

    Change from baseline scores on the dysphagia EAT 10 Screening is a screening tool to help measure swallowing difficulties, dysphagia severity & monitor treatment response. It is a likert scale from 0-4, with a maximum score of 40. If the EAT-10 score is 3 or higher, this could indicate problems swallowing efficiently or safely.

  24. Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening.

    Time frame: Baseline to Month 12

    Change from baseline scores on the dysphagia EAT 10 Screening is a screening tool to help measure swallowing difficulties, dysphagia severity & monitor treatment response. It is a likert scale from 0-4, with a maximum score of 40. If the EAT-10 score is 3 or higher, this could indicate problems swallowing efficiently or safely.

Sponsors and collaborators

Lead sponsor

West Virginia University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2024
First posted
Oct 18, 2018
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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