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

• ClinicalTrials.gov Identifier: NCT03711474
• Recruitment Status: Active, not recruiting
• First Posted: October 18, 2018
• Last Update Posted: March 23, 2023
• Sponsor: West Virginia University
• Information provided by (Responsible Party): Scott Daffner, West Virginia University

Tracking Information

• First Submitted Date: August 2, 2018
• First Posted Date: October 18, 2018
• Last Update Posted Date: March 23, 2023
• Actual Study Start Date: September 7, 2018
• Estimated Primary Completion Date: July 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 17, 2018)

Change in the occurrence of dysphagia and its associated complications [ Time Frame: one year ]

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

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Dysphagia Following Anterior Cervical Spine Surgery; Single Dose Steroid vs Saline (DysDexVSSal)
• Official Title: Impact of Single Dose Perioperative Steroids on Dysphagia Following Anterior Cervical Spine Surgery: A Randomized, Prospective, Double-Blind Study
• 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

Detailed 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.

• Study Type: Interventional
• Study Phase: Phase 4

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Randomized; double blinded (participant and investigator)

Masking: Double (Participant, Investigator)
Masking Description:

Double blinded (participant and investigator)

Primary Purpose: Prevention

• Condition: Dysphagia

Intervention

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

Study Arms

• Experimental: Treatment 1; Dexamethasone

  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.

  Intervention: Drug: Dexamethasone
• Placebo Comparator: Treatment 0; Placebo

  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.

  Intervention: Drug: Saline

Publications *

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: October 17, 2018): 80
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 2024
• Estimated Primary Completion Date: July 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03711474
• Other Study ID Numbers: 1804077978
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Scott Daffner, West Virginia University
• Original Responsible Party: Same as current
• Current Study Sponsor: West Virginia University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Scott Daffner, MD; West Virginia University

• PRS Account: West Virginia University
• Verification Date: March 2023