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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03711474
Recruitment Status : Active, not recruiting
First Posted : October 18, 2018
Last Update Posted : March 23, 2023
Sponsor:
Information provided by (Responsible Party):
Scott Daffner, West Virginia University

Study Description
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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
Dysphagia Drug: Dexamethasone Drug: Saline 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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
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
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 : September 7, 2018
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03711474


Locations
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United States, West Virginia
West Virginia University Department of Orthopaedics
Morgantown, West Virginia, United States, 26506
Sponsors and Collaborators
West Virginia University
Investigators
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Principal Investigator: Scott Daffner, MD West Virginia University
More Information
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Publications:

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Responsible Party: Scott Daffner, Associate Professor, MD, West Virginia University
ClinicalTrials.gov Identifier: NCT03711474    
Other Study ID Numbers: 1804077978
First Posted: October 18, 2018    Key Record Dates
Last Update Posted: March 23, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Dexamethasone
Anti-Inflammatory Agents
Antiemetics
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents