Dysphagia After Anterior Cervical Decompression and Fusion of the SpinePhase 3NCT02266797
Effect of Intravenous Corticosteroid Injections on Dysphagia After Cervical Spine Surgery
A Phase 3 study testing Dexamethasone and Saline in people with Dysphagia After Anterior Cervical Decompression and Fusion of the Spine, run by NYU Langone Health at 3 sites in United States.
Trial summary
This is a randomized, double-blind, placebo-controlled study to examine the effect of local intravenous steroids following anterior cervical spine surgery on the development of dysphagia in patients. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Dysphagia After Anterior Cervical Decompression and Fusion of the Spine
- What is being tested?
- Dexamethasone and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2013to 1 Sep 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subjects included in the study are patients undergoing an anterior cervical spine procedure.
Who cannot join
- Patients with greater than ASA grade II will be excluded. Patients with non-degenerative conditions, such as trauma, tumors, infection, radiation, and diabetes will be excluded. Patients with posterior procedures will be excluded. Patients with clinical pre-operative dysphagia, indicated by a score of 3 or higher on the EAT-10 questionnaire,19 will also be excluded. Patients who are pregnant will be excluded from this study.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Center for Musculoskeletal Care (CMC)
New York, New York, 10016
NYU Langone Medical Center
New York, New York, 10016
NY Spine Institute
Westbury, New York, 11590
About this study
Official title: Effect of Intravenous Corticosteroid Injections on Dysphagia After Anterior Cervical Spine Surgery: a Randomized, Double-blind, Placebo-controlled Study
This is a randomized, double-blind, placebo-controlled study to examine the effect of local intravenous steroids following anterior cervical spine surgery on the development of dysphagia in patients.
Read the detailed description
The purpose of this randomized, double-blind, placebo-controlled study is to examine the effect of local intravenous steroids following anterior cervical spine surgery on the development of dysphagia in patients. This study aims to investigate if there is a difference in the efficacy of intravenous steroids compared to a placebo of physiological saline for patients undergoing anterior cervical spine surgery. Furthermore, this study aims to investigate the correlation between radiographic measurements of soft tissue swelling and the severity of dysphagia for patients. Finally, this study aims to examine the impact of intravenous steroids on nausea and radicular pain in patients. Secondary outcome measures will include patient focused outcomes questionnaires, pain medication requirements, and fusion rates.
- Being tested
- Dexamethasone, Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose.
SalineOther
The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose.
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Active comparator | Subject will receive doses of intravenous dexamethasone, a corticosteroid. The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose. Receives: Drug: Dexamethasone |
| Saline | Placebo comparator | Subject will receive doses of intravenous physiological saline solution. Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intravenous Corticosteroids Effect on Post-operative Dysphagia
The severity of dysphagia will be evaluated by dysphagia questionnaires and a two week postoperative swallow evaluation by a licensed swallowing expert. If recommended by the swallow evaluation, a videofluoroscopic swallow study (VFSS) will be performed to further evaluate the severity of dysphagia.
Measured: 12 months
The Correlation Between Radiographic Data and the Extent of Dysphagia in Patients.
Soft-tissue swelling will be measured by the anterior cervical soft-tissue shadow width on lateral cervical radiographs. The extent of dysphagia will be evaluated by the dysphagia questionnaires, the swallow evaluation, and the VFSS, if necessary.
Measured: 12 months
Secondary outcomes (4)
The Efficacy of Intravenous Steroids on Aspiration Rates of Patients Undergoing Anterior Cervical Spine Surgery.
Aspiration rates will be evaluated by the percentage of patients in each group with post-operative aspiration.
Measured: 12 months
Examine the Impact of Dexamethasone on the Development of Postoperative Nausea.
This will be quantified by the visual analogue scale (VAS) questionnaire for nausea and measuring the number of vomiting episodes following surgery.
Measured: Immediate post-operatively
Examine the Impact of Dexamethasone on Radicular Pain.
This will be quantified by the NDI questionnaire and VAS questionnaire for neck pain and arm pain.
Measured: 12 months
Examine Whether Intravenous Steroids Affect the Outcomes of Surgery, for Example, Fusion Rates.
The outcomes of surgery will be examined through the 1 year post-operative appointment.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study startNov 2013
- Primary completion1 Sep 2015
- Study completion1 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Dysphagia After Anterior Cervical Decompression and Fusion of the SpineStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02266797
- Sponsor's protocol ID
- 13-00108
- Status last verified
- Sep 2018
- First submitted
- 2 Oct 2014
- Last updated
- 25 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Leonard R, Belafsky P. Dysphagia following cervical spine surgery with anterior instrumentation: evidence from fluoroscopic swallow studies. Spine (Phila Pa 1976). 2011 Dec 1;36(25):2217-23. doi: 10.1097/BRS.0b013e318205a1a7.
PubMed 21325988Bazaz R, Lee MJ, Yoo JU. Incidence of dysphagia after anterior cervical spine surgery: a prospective study. Spine (Phila Pa 1976). 2002 Nov 15;27(22):2453-8. doi: 10.1097/00007632-200211150-00007.
PubMed 12435974Stewart M, Johnston RA, Stewart I, Wilson JA. Swallowing performance following anterior cervical spine surgery. Br J Neurosurg. 1995;9(5):605-9. doi: 10.1080/02688699550040882.
PubMed 8561932Winslow CP, Winslow TJ, Wax MK. Dysphonia and dysphagia following the anterior approach to the cervical spine. Arch Otolaryngol Head Neck Surg. 2001 Jan;127(1):51-5. doi: 10.1001/archotol.127.1.51.
PubMed 11177014Martin RE, Neary MA, Diamant NE. Dysphagia following anterior cervical spine surgery. Dysphagia. 1997 Winter;12(1):2-8; discussion 9-10. doi: 10.1007/pl00009513.
PubMed 8997826
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravenous Corticosteroid Injections on Dysphagia After Anterior Cervical Spine Surgery: a Randomized, Double-blind, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT02266797
- Acronym / sponsor ID
- 13-00108
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 4 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- 1 Sep 2015 (actual)
- Study completion
- 1 Sep 2015 (actual)
- First posted
- 17 Oct 2014 (estimated)
- Results
- Posted 14 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-blind, placebo-controlled study to examine the effect of local intravenous steroids following anterior cervical spine surgery on the development of dysphagia in patients.
Detailed description
The purpose of this randomized, double-blind, placebo-controlled study is to examine the effect of local intravenous steroids following anterior cervical spine surgery on the development of dysphagia in patients. This study aims to investigate if there is a difference in the efficacy of intravenous steroids compared to a placebo of physiological saline for patients undergoing anterior cervical spine surgery. Furthermore, this study aims to investigate the correlation between radiographic measurements of soft tissue swelling and the severity of dysphagia for patients. Finally, this study aims to examine the impact of intravenous steroids on nausea and radicular pain in patients. Secondary outcome measures will include patient focused outcomes questionnaires, pain medication requirements, and fusion rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Active comparator | Drug: DexamethasoneSubject will receive doses of intravenous dexamethasone, a corticosteroid. The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose. |
| Saline | Placebo comparator | Other: SalineSubject will receive doses of intravenous physiological saline solution. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The subjects included in the study are patients undergoing an anterior cervical spine procedure.
Key exclusion criteria (1 listed)
- Patients with greater than ASA grade II will be excluded. Patients with non-degenerative conditions, such as trauma, tumors, infection, radiation, and diabetes will be excluded. Patients with posterior procedures will be excluded. Patients with clinical pre-operative dysphagia, indicated by a score of 3 or higher on the EAT-10 questionnaire,19 will also be excluded. Patients who are pregnant will be excluded from this study.
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 |
|---|---|---|
| DexamethasoneThe first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose. | Drug | Dexamethasone |
| SalineThe first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. | Other | Saline |
Primary outcome
Intravenous Corticosteroids Effect on Post-operative Dysphagia
Time frame: 12 months
The severity of dysphagia will be evaluated by dysphagia questionnaires and a two week postoperative swallow evaluation by a licensed swallowing expert. If recommended by the swallow evaluation, a videofluoroscopic swallow study (VFSS) will be performed to further evaluate the severity of dysphagia.
The Correlation Between Radiographic Data and the Extent of Dysphagia in Patients.
Time frame: 12 months
Soft-tissue swelling will be measured by the anterior cervical soft-tissue shadow width on lateral cervical radiographs. The extent of dysphagia will be evaluated by the dysphagia questionnaires, the swallow evaluation, and the VFSS, if necessary.
4 secondary outcomes
The Efficacy of Intravenous Steroids on Aspiration Rates of Patients Undergoing Anterior Cervical Spine Surgery.
Time frame: 12 months
Examine the Impact of Dexamethasone on the Development of Postoperative Nausea.
Time frame: Immediate post-operatively
Examine the Impact of Dexamethasone on Radicular Pain.
Time frame: 12 months
Examine Whether Intravenous Steroids Affect the Outcomes of Surgery, for Example, Fusion Rates.
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21325988Leonard R, Belafsky P. Dysphagia following cervical spine surgery with anterior instrumentation: evidence from fluoroscopic swallow studies. Spine (Phila Pa 1976). 2011 Dec 1;36(25):2217-23. doi: 10.1097/BRS.0b013e318205a1a7.
- Background: PubMed 12435974Bazaz R, Lee MJ, Yoo JU. Incidence of dysphagia after anterior cervical spine surgery: a prospective study. Spine (Phila Pa 1976). 2002 Nov 15;27(22):2453-8. doi: 10.1097/00007632-200211150-00007.
- Background: PubMed 8561932Stewart M, Johnston RA, Stewart I, Wilson JA. Swallowing performance following anterior cervical spine surgery. Br J Neurosurg. 1995;9(5):605-9. doi: 10.1080/02688699550040882.
- Background: PubMed 11177014Winslow CP, Winslow TJ, Wax MK. Dysphonia and dysphagia following the anterior approach to the cervical spine. Arch Otolaryngol Head Neck Surg. 2001 Jan;127(1):51-5. doi: 10.1001/archotol.127.1.51.
- Background: PubMed 8997826Martin RE, Neary MA, Diamant NE. Dysphagia following anterior cervical spine surgery. Dysphagia. 1997 Winter;12(1):2-8; discussion 9-10. doi: 10.1007/pl00009513.
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexamethasone and Saline in people with Dysphagia After Anterior Cervical Decompression and Fusion of the Spine, run by NYU Langone Health at 3 sites in United States.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 25 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Intravenous Corticosteroids Effect on Post-operative Dysphagia (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02266797, which also lists 5 linked publications.
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 25 Oct 2018.