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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
Must not have
Patients on chronic steroids
Traumatic or tumor etiologies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
Summary
This trial is testing whether a single dose of steroids given through an IV can help with swallowing problems after neck surgery. The study focuses on patients who have anterior cervical spine surgery. Steroids might help by reducing inflammation and swelling, making it easier for these patients to swallow after their operation.
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.
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.
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 belowSelect...
I am scheduled for a specific neck surgery from the front, targeting vertebrae C3 to T1.
Select...
I am between 18 and 80 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am on long-term steroid medication.
Select...
My condition is due to an injury or tumor.
Select...
I am under 18 years old.
Select...
I have had surgery on the front part of my neck spine before.
Select...
I need surgery for a tumor or infection.
Select...
I am on a breathing machine after surgery.
Select...
I am having surgery that involves both the front and back of my body.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in the occurrence of dysphagia and its associated complications
Side effects data
From 2013 Phase 4 trial • 122 Patients • NCT014749152%
Cerebrospinal fluid leak
2%
Deep Vein Thrombosis
2%
Fever
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ondansetron
Aprepitant
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
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
~2650
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for swallowing difficulty, particularly the use of perioperative IV steroids, work primarily through their anti-inflammatory effects. Steroids like dexamethasone reduce swelling and inflammation in the tissues surrounding the esophagus, which can alleviate pressure and improve esophageal function.
This is crucial for patients with swallowing difficulties as it can significantly enhance their ability to swallow, reduce discomfort, and improve overall quality of life. Other treatments may include behavioral therapies, dietary modifications, and surgical interventions, all aimed at addressing the underlying causes of dysphagia.
The effect of local intraoperative corticosteroid application on postoperative dysphagia following anterior cervical spine surgery.The Effect of Local Intraoperative Steroid Administration on the Rate of Postoperative Dysphagia Following ACDF: A Study of 245,754 Patients.Oesophageal lichen planus: the efficacy of topical steroid-based therapies.
The effect of local intraoperative corticosteroid application on postoperative dysphagia following anterior cervical spine surgery.The Effect of Local Intraoperative Steroid Administration on the Rate of Postoperative Dysphagia Following ACDF: A Study of 245,754 Patients.Oesophageal lichen planus: the efficacy of topical steroid-based therapies.
Find a Location
Who is running the clinical trial?
West Virginia UniversityLead Sponsor
183 Previous Clinical Trials
63,785 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on long-term steroid medication.My condition is due to an injury or tumor.I have had surgery on the front part of my neck spine before.I am under 18 years old.I am having surgery that involves both the front and back of my body.I need surgery for a tumor or infection.I am scheduled for a specific neck surgery from the front, targeting vertebrae C3 to T1.I am between 18 and 80 years old.I am on a breathing machine after surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment 1; Dexamethasone
- Group 2: Treatment 0; Placebo
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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