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

NCT03711474 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 1804077978
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Dysphagia

Outcome Measures

Primary Outcomes (24)

• Change in the Occurrence of Dysphagia -Bazaz Scale

  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.

  Baseline to Day 1

• Change in the Occurrence of Dysphagia -Bazaz Scale

  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.

  Baseline to Day 2

• Change in the Occurrence of Dysphagia -Bazaz Scale

  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.

  Baseline to Week 1

• Change in the Occurrence of Dysphagia -Bazaz Scale

  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.

  Baseline to Week 2

• Change in the Occurrence of Dysphagia -Bazaz Scale

  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.

  Baseline to Month 3

• Change in the Occurrence of Dysphagia -Bazaz Scale

  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.

  Baseline to Month 12

• Change in the Occurrence of Dysphagia -Bazaz Scale

  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.

  Baseline to Month 1

• Change in the Occurrence of Dysphagia -Bazaz Scale

  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.

  Baseline to Month 6

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

  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.

  Baseline to Day 1

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

  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.

  Baseline to Day 2

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

  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.

  Baseline to Week 1

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

  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.

  Baseline to Week 2

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

  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.

  Baseline to Month 1

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

  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.

  Baseline to Month 3

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

  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.

  Baseline to Month 6

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

  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.

  Baseline to Month 12

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

  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.

  Baseline to Day 1

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

  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.

  Baseline to Day 2

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

  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.

  Baseline to Week 1

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

  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.

  Baseline to Week 2

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

  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.

  Baseline to Month 1

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

  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.

  Baseline to Month 3

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

  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.

  Baseline to Month 6

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

  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.

  Baseline to Month 12

Study Arms (2)

Treatment 1; Dexamethasone

EXPERIMENTAL

Drug: Treatment 1; Dexamethasone. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10 and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery. Patients will be randomized to either the single dose steroid administration group or the single dose saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of incision.

Drug: Dexamethasone

Treatment 0; Placebo

PLACEBO COMPARATOR

Drug: Treatment 0; Saline placebo. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10, and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery. Patients will be randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of the incision.

Drug: Saline

Interventions

Dexamethasone DRUG

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

Also known as: Steroid

Treatment 1; Dexamethasone

Saline DRUG

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

Treatment 0; Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective anterior approach to subaxial cervical spine (C3 - T1);
• ages 18-80

You may not qualify if:

• 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

Sponsors & Collaborators

• West Virginia University: lead

Study Sites (1)

West Virginia University Department of Orthopaedics

Morgantown, West Virginia, 26506, United States

Location

Related Publications (6)

• 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.

  PMID: 24929058 BACKGROUND

• 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.

  PMID: 25932600 BACKGROUND

• 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.

  PMID: 21325988 BACKGROUND

• 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.

  PMID: 12435974 BACKGROUND

• 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.

  PMID: 22037524 BACKGROUND

• 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.

  PMID: 19140539 BACKGROUND

MeSH Terms

Conditions

Deglutition Disorders

Interventions

Dexamethasone; Steroids; Sodium Chloride

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Scott Daffner, MD
• Organization: West Virginia University

sdaffner@hsc.wvu.edu

304-293-1172

Study Officials

• Scott Daffner, MD

  West Virginia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blinded (participant and investigator)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, MD

Model Details: Randomized; double blinded (participant and investigator)

Study Record Dates

• First Submitted: August 2, 2018
• First Posted: October 18, 2018
• Study Start: September 7, 2018
• Primary Completion: July 30, 2023
• Study Completion: July 30, 2024
• Last Updated: February 12, 2025
• Results First Posted: February 12, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)