DysphagiaSHDDNCT03256149
High Dose Steroids for Dysphagia
A study testing Dexamethasone in people with Dysphagia and Cervical Spine Disease, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
Few existing data currently indicates that anti-inflammatory drugs could help diminish the local cervical inflammation tough to cause the dysphagia, hoarseness and dyspnea after an anterior surgical approach to the spine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysphagia, Cervical Spine Disease
- What is being tested?
- Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 24 Mar 2015to Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Anterior cervical spine surgery
- Elective surgery
Who cannot join
- Takes steroids for any reason
- Pre-existing condition leading to dysphagia
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2L4M1
About this study
Official title: Effect of High Dose Steroids on Dysphagia After Anterior Spinal Surgery: a Randomized Controlled Trial
Few existing data currently indicates that anti-inflammatory drugs could help diminish the local cervical inflammation tough to cause the dysphagia, hoarseness and dyspnea after an anterior surgical approach to the spine. This study aims to evaluate the effect of high dose of steroids on dysphagia after an anterior cervical spine procedure. Patients subjected to a cervical spine surgery through an anterior approach will be randomized to a treatment group receiving 3 doses of IV dexamethasone (decadron) and a placebo group receiving saline. Outcome will be measured with dysphagia scales, modified barium swallow and rhino-pharyngo-laryngoscopy, all done pre and post-operatively. Secondary outcomes involve neurological condition, pain and fusion rate.
- Conditions
- Dysphagia, Cervical Spine Disease
- Being tested
- Dexamethasone, Placebo
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called Decradron
PlaceboDrug
Also called Saline
Normal saline (IV placebo)
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Dexamethasone, 4 mg IV given at 8 hours interval, first dose received at the time of surgery (induction), 3 doses total Receives: Drug: Dexamethasone |
| Placebo group | Placebo comparator | Saline given at 8 hours interval, first dose received at the time of surgery (induction), 3 doses total Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Voice evaluation
Voice handicap index
Measured: First day post-operatively
Dysphagia evaluation: MBSimp
Modified Barium Swallow with the calculation fof the MBSimp score
Measured: First day post-operatively
Soft tissue edema
Pre-vertebral soft tissue edema on X Ray
Measured: First day post-operatively
Airway evaluation
Rhino-Pharyngo-Laryngoscopy
Measured: First day post-operatively
Dysphagia evaluation: Rosenbeck
Modified Barium Swallow with calculation of the Rosenbeck score
Measured: First day post-operatively
Secondary outcomes (6)
Hyperreflexia
hyperreflexia assesment using osteotendinous reflexes graded on a 1 to 4 scale
Measured: 3 months post-operatively
Fusion rate
Cervical spine fusion at site of surgery seen on CT scan
Measured: 6 months after surgery
Pain
Subjective neck pain using analog pain scale
Measured: 3 months after surgery
Strenght
4 limbs strengh assessment on a 0 to 5 scale
Measured: 3 months after surgery
Crude touch sensation
Presence or absence of hypoesthesia in the limbs
Measured: 3 months after surgery
Surgical site infection
Presence or absence of superficial or deep surgical site infection
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2017
- Study start24 Mar 2015
- Primary completionNov 2018 (estimated)
- Study completionFeb 2019 (estimated)
Why it stopped: Not enough patients recruted
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03256149
- Sponsor's protocol ID
- CE 14.247
- Acronym
- SHDD
- Status last verified
- Dec 2022
- First submitted
- 17 Aug 2017
- Last updated
- 14 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High Dose Steroids on Dysphagia After Anterior Spinal Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03256149
- Acronym / sponsor ID
- SHDD / CE 14.247
- Conditions
- Dysphagia, Cervical Spine Disease
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not enough patients recruted
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 24 Mar 2015 (actual)
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 21 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Few existing data currently indicates that anti-inflammatory drugs could help diminish the local cervical inflammation tough to cause the dysphagia, hoarseness and dyspnea after an anterior surgical approach to the spine. This study aims to evaluate the effect of high dose of steroids on dysphagia after an anterior cervical spine procedure. Patients subjected to a cervical spine surgery through an anterior approach will be randomized to a treatment group receiving 3 doses of IV dexamethasone (decadron) and a placebo group receiving saline. Outcome will be measured with dysphagia scales, modified barium swallow and rhino-pharyngo-laryngoscopy, all done pre and post-operatively. Secondary outcomes involve neurological condition, pain and fusion rate.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: DexamethasoneDexamethasone, 4 mg IV given at 8 hours interval, first dose received at the time of surgery (induction), 3 doses total |
| Placebo group | Placebo comparator | Drug: PlaceboSaline given at 8 hours interval, first dose received at the time of surgery (induction), 3 doses total |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Anterior cervical spine surgery
- Elective surgery
Key exclusion criteria (2 listed)
- Takes steroids for any reason
- Pre-existing condition leading to dysphagia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethasoneAlso: Decradron | Drug | Treatment group |
| PlaceboAlso: SalineNormal saline (IV placebo) | Drug | Placebo group |
Primary outcome
Voice evaluation
Time frame: First day post-operatively
Voice handicap index
Dysphagia evaluation: MBSimp
Time frame: First day post-operatively
Modified Barium Swallow with the calculation fof the MBSimp score
Soft tissue edema
Time frame: First day post-operatively
Pre-vertebral soft tissue edema on X Ray
Airway evaluation
Time frame: First day post-operatively
Rhino-Pharyngo-Laryngoscopy
Dysphagia evaluation: Rosenbeck
Time frame: First day post-operatively
Modified Barium Swallow with calculation of the Rosenbeck score
6 secondary outcomes
Hyperreflexia
Time frame: 3 months post-operatively
Fusion rate
Time frame: 6 months after surgery
Pain
Time frame: 3 months after surgery
Strenght
Time frame: 3 months after surgery
Crude touch sensation
Time frame: 3 months after surgery
Surgical site infection
Time frame: 3 months after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone in people with Dysphagia and Cervical Spine Disease, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Voice evaluation (time frame: First day post-operatively). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2022.