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Corticosteroid

Steroid for Swallowing Difficulty

Phase 4

Waitlist Available

Led By Scott Daffner, MD

Research Sponsored by West Virginia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Elective anterior approach to subaxial cervical spine (C3 - T1)

Ages 18-80

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one year

Awards & highlights

Study Summary

This trial looks at whether a single dose of a steroid given intravenously can improve swallowing function after anterior cervical spine surgery, compared to a control group who received a saline solution.

Who is the study for?

This trial is for adults aged 18-80 who are having elective neck spine surgery from the front (C3 - T1 level). It's not for those with past neck surgeries, on long-term steroids, pregnant, without a phone, or needing to wear a halo vest after surgery. People with trauma or tumors aren't eligible either.Check my eligibility

What is being tested?

The study is testing if giving a single dose of Dexamethasone (a steroid) instead of saline (saltwater) during surgery can help with swallowing difficulties that sometimes follow anterior cervical spine operations. Participants won't know which treatment they receive.See study design

What are the potential side effects?

Dexamethasone may cause side effects like increased blood sugar levels, mood changes, stomach ulcers, and trouble fighting infections. Saline typically has no side effects but might cause vein irritation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for a specific neck surgery from the front, targeting vertebrae C3 to T1.

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I am between 18 and 80 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one year

This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in the occurrence of dysphagia and its associated complications

Side effects data

From 2013 Phase 4 trial • 122 Patients • NCT01474915

Deep Vein Thrombosis

Cerebrospinal fluid leak

Fever

100%

80%

60%

40%

20%

Study treatment Arm

Ondansetron

Aprepitant

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Treatment 1; DexamethasoneExperimental Treatment1 Intervention

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.

Group II: Treatment 0; PlaceboPlacebo Group1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

2007

Completed Phase 4

~2590

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

West Virginia UniversityLead Sponsor

175 Previous Clinical Trials

56,226 Total Patients Enrolled

Scott Daffner, MDPrincipal Investigator - West Virginia University

Chestnut Ridge Hospital, Ruby Memorial Hospital, West Virginia Hospitals Inc

Jefferson Medical Coll-Thos Jefferson University (Medical School)

Thos Jefferson University Hospital (Residency)

1 Previous Clinical Trials

42 Total Patients Enrolled

Media Library

Dexamethasone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT03711474 — Phase 4

Swallowing Difficulty Research Study Groups: Treatment 1; Dexamethasone, Treatment 0; Placebo

Swallowing Difficulty Clinical Trial 2023: Dexamethasone Highlights & Side Effects. Trial Name: NCT03711474 — Phase 4

Dexamethasone (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03711474 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any safety risks associated with Dexamethasone consumption?

"There is ample evidence that Dexamethasone is safe so it has been given a score of 3. This drug was approved for use in the fourth phase of trials, which supports its safety profile."

Answered by AI

Is this clinical study recruiting geriatric patients?

"As indicated by the trial eligibility requirements, applicants must be aged between 18 and 80 years old. Other trials for those under 18 or over 65 can also be found; there are 81 separate studies dedicated to minors and 551 geared towards elderly patients."

Answered by AI

Is recruitment currently underway for this particular experiment?

"Affirmative. Clinicaltrials.gov verifies that this medical trial, which was initially announced on September 7th 2018 is still recruiting patients - with the latest edition occurring October 17th 2022. 80 individuals will be needed from 1 location to complete the research project."

Answered by AI

What other scientific inquiries have been made with regards to Dexamethasone?

"Presently, there are 553 clinical trials investigating the potential of Dexamethasone. Of these studies, 144 have proceeded to Phase 3 testing. While Major cities such as Mishawaka, Indiana host a large number of research sites for this treatment; in total 18618 locations worldwide are running studies with Dexamethasone."

Answered by AI

For what clinical purposes is Dexamethasone typically utilized?

"Dexamethasone can effectively ameliorate ophthalmia, sympathetic eye disorders, and branch retinal vein occlusion."

Answered by AI

How many individuals have volunteered for this medical investigation?

"Affirmative. Examining the information available on clinicaltrials.gov, one can conclude that this medical experiment began recruiting patients since September 7th 2018 and is still active today. The research requires 80 individuals across 1 site to be enrolled in it."

Answered by AI

Is there an opportunity for me to take part in this investigation?

"This medical study is in search of 80 people with dysphagia aged 18 to 80. The primary eligibility criteria revolves around age, needing those taking part to be between the aforementioned ages."

Answered by AI

Recent research and studies

Annals of Otology, Rhinology & LaryngologyJournal

Validity and Reliability of the Eating Assessment Tool (EAT-10)

Belafsky, Peter C., Debbie A. Mouadeb, Catherine J. Rees, Jan C. Pryor, Gregory N. Postma, Jacqueline Allen, and Rebecca J. Leonard. 2008. “Validity and Reliability of the Eating Assessment Tool (EAT-10)”. Annals of Otology, Rhinology & Laryngology. SAGE Publications. doi:10.1177/000348940811701210.

Journal of Neurosurgery: SpineJournal

Effect of Steroid Use in Anterior Cervical Discectomy and Fusion: A Randomized Controlled Trial

Jeyamohan, Shiveindra B., Tyler J. Kenning, Karen A. Petronis, Paul J. Feustel, Doniel Drazin, and Darryl J. DiRisio. 2015. “Effect of Steroid Use in Anterior Cervical Discectomy and Fusion: A Randomized Controlled Trial”. Journal of Neurosurgery: Spine. Journal of Neurosurgery Publishing Group (JNSPG). doi:10.3171/2014.12.spine14477.

The Spine JournalJournal

The Clinical Efficacy of Short-term Steroid Treatment in Multilevel Anterior Cervical Arthrodesis

Song, Kyung-Jin, Su-Kyung Lee, Jong-Hyun Ko, Myung-Jae Yoo, Do-Yeon Kim, and Kwang-Bok Lee. 2014. “The Clinical Efficacy of Short-term Steroid Treatment in Multilevel Anterior Cervical Arthrodesis”. The Spine Journal. Elsevier BV. doi:10.1016/j.spinee.2014.06.005.

SpineJournal