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

Sponsor
West Virginia University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03711474
Collaborator
(none)
80
1
2
58.8
1.4

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized; double blinded (participant and investigator)Randomized; double blinded (participant and investigator)
Masking:
Double (Participant, Investigator)
Masking Description:
Double blinded (participant and investigator)
Primary Purpose:
Prevention
Official Title:
Impact of Single Dose Perioperative Steroids on Dysphagia Following Anterior Cervical Spine Surgery: A Randomized, Prospective, Double-Blind Study
Actual Study Start Date :
Sep 7, 2018
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

Arm Intervention/Treatment
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.

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

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

    Outcome Measures

    Primary Outcome Measures

    1. Change in the occurrence of dysphagia and its associated complications [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 West Virginia University Department of Orthopaedics Morgantown West Virginia United States 26506

    Sponsors and Collaborators

    • West Virginia University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Scott Daffner, Associate Professor, MD, West Virginia University
    ClinicalTrials.gov Identifier:
    NCT03711474
    Other Study ID Numbers:
    • 1804077978
    First Posted:
    Oct 18, 2018
    Last Update Posted:
    Mar 11, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 11, 2022