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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Saline | Placebo Comparator | Subject will receive doses of intravenous physiological saline solution. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Examine the Impact of Dexamethasone on the Development of Postoperative Nausea. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Musculoskeletal Care (CMC) | New York | New York | 10016 | United States | ||
| NYU Langone Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21325988 | Background | 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. | |
| 12435974 | Background | Bazaz 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dexamethasone | 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. Dexamethasone: 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. |
| FG001 | Saline | Subject will receive doses of intravenous physiological saline solution. Saline: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dexamethasone | 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. Dexamethasone: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Data not available due to premature halting of study | Posted | 12 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dexamethasone | 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. Dexamethasone: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Gerling | NYU Langone Medical Center | (718) 630-8600 | Michael.Gerling@nyumc.org |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Saline | Other | The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. |
|
This will be quantified by the visual analogue scale (VAS) questionnaire for nausea and measuring the number of vomiting episodes following surgery. |
| 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. | 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. | 12 months |
| New York |
| New York |
| 10016 |
| United States |
| NY Spine Institute | Westbury | New York | 11590 | United States |
| 8561932 | Background | Stewart 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. |
| 11177014 | Background | Winslow 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. |
| 8997826 | Background | Martin 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. |
| BG001 | Saline | Subject will receive doses of intravenous physiological saline solution. Saline: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Saline | Subject will receive doses of intravenous physiological saline solution. Saline: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. |
|
| Primary | 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. | Data not available due to premature halting of study | Posted | 12 months |
|
|
| Secondary | 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. | Data not available due to premature halting of study | Posted | 12 months |
|
|
| Secondary | 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. | Data not available due to premature halting of study | Posted | Immediate post-operatively |
|
|
| Secondary | 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. | Data not available due to premature halting of study | Posted | 12 months |
|
|
| Secondary | 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. | Data not available due to premature halting of study | Posted | 12 months |
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Saline | Subject will receive doses of intravenous physiological saline solution. Saline: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. | 0 | 3 | 0 | 3 |
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| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |