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This prospective, randomized, double blind, controlled study evaluates the effect of a single dose of perioperative IV steroid versus saline on swallowing after anterior cervical spine surgery
This investigation is a prospective, randomized, double-blind, controlled trial testing a single dose of peri-operative steroid versus saline and the effect on swallowing after anterior cervical spine surgery.
Swallowing symptoms will be measured using the patient reported Bazaz (Bazaz) scale, the EAT10 survey, and the Dysphagia Short Questionnaire (DSQ). Swallowing data will be obtained pre-operatively, one day and two days post-operatively and then one week, two weeks, four weeks, three months, six months, and one year post-operatively. Patient clinical outcomes will be captured using web-based progress reports. Patients will complete the Quality of Life (QoL-12), Neck Disability Index (NDI), and Visual Analog Scale (VAS) questionnaires electronically pre-operatively and at one year post-operatively. This outcome data will help us analyze the swallowing function or symptoms with the overall clinical course of the patients enrolled in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment 1; Dexamethasone | Experimental | 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. |
|
| Treatment 0; Placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Occurrence of Dysphagia -Bazaz Scale | Change from baseline scores on the dysphagia Bazaz Scale. • Bazaz grading system is designed for the evaluation of swallowing difficulty after cervical surgery. The patients are graded on a scale as having None (0), Mild (1), Moderate (2), or Severe (3) dysphagia based on their symptoms. None (0) or Mild (1) dysphagia is considered to be a better outcome. | Baseline to Day 1 |
| Change in the Occurrence of Dysphagia -Bazaz Scale | Change from baseline scores on the dysphagia Bazaz Scale. • Bazaz grading system is designed for the evaluation of swallowing difficulty after cervical surgery. The patients are graded on a scale as having None (0), Mild (1), Moderate (2), or Severe (3) dysphagia based on their symptoms. None (0) or Mild (1) dysphagia is considered to be a better outcome. | Baseline to Day 2 |
| Change in the Occurrence of Dysphagia -Bazaz Scale | Change from baseline scores on the dysphagia Bazaz Scale. • Bazaz grading system is designed for the evaluation of swallowing difficulty after cervical surgery. The patients are graded on a scale as having None (0), Mild (1), Moderate (2), or Severe (3) dysphagia based on their symptoms. None (0) or Mild (1) dysphagia is considered to be a better outcome. | Baseline to Week 1 |
| Change in the Occurrence of Dysphagia -Bazaz Scale | Change from baseline scores on the dysphagia Bazaz Scale. • Bazaz grading system is designed for the evaluation of swallowing difficulty after cervical surgery. The patients are graded on a scale as having None (0), Mild (1), Moderate (2), or Severe (3) dysphagia based on their symptoms. None (0) or Mild (1) dysphagia is considered to be a better outcome. | Baseline to Week 2 |
| Change in the Occurrence of Dysphagia -Bazaz Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott Daffner, MD | West Virginia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Virginia University Department of Orthopaedics | Morgantown | West Virginia | 26506 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24929058 | Background | Song KJ, Lee SK, Ko JH, Yoo MJ, Kim DY, Lee KB. The clinical efficacy of short-term steroid treatment in multilevel anterior cervical arthrodesis. Spine J. 2014 Dec 1;14(12):2954-8. doi: 10.1016/j.spinee.2014.06.005. Epub 2014 Jun 12. | |
| 25932600 | Background | Jeyamohan SB, Kenning TJ, Petronis KA, Feustel PJ, Drazin D, DiRisio DJ. Effect of steroid use in anterior cervical discectomy and fusion: a randomized controlled trial. J Neurosurg Spine. 2015 Aug;23(2):137-43. doi: 10.3171/2014.12.SPINE14477. Epub 2015 May 1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment 1; Dexamethasone | 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. Dexamethasone: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery |
| FG001 | Treatment 0; Placebo | 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. Saline: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment 1; Dexamethasone | 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. Dexamethasone: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery |
| 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 | Change in the Occurrence of Dysphagia -Bazaz Scale | Change from baseline scores on the dysphagia Bazaz Scale. • Bazaz grading system is designed for the evaluation of swallowing difficulty after cervical surgery. The patients are graded on a scale as having None (0), Mild (1), Moderate (2), or Severe (3) dysphagia based on their symptoms. None (0) or Mild (1) dysphagia is considered to be a better outcome. | Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline to Day 1 |
|
Adverse Events were collected over the year of patient enrollment.
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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 | Treatment 1; Dexamethasone | 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. Dexamethasone: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| appendix removal | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scott Daffner, MD | West Virginia University | 304-293-1172 | sdaffner@hsc.wvu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 4, 2019 | Aug 27, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 9, 2022 | Aug 27, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D013256 | Steroids |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D000072473 | Fused-Ring Compounds |
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Randomized; double blinded (participant and investigator)
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Double blinded (participant and investigator)
| Saline | Drug | Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery |
|
Change from baseline scores on the dysphagia Bazaz Scale. • Bazaz grading system is designed for the evaluation of swallowing difficulty after cervical surgery. The patients are graded on a scale as having None (0), Mild (1), Moderate (2), or Severe (3) dysphagia based on their symptoms. None (0) or Mild (1) dysphagia is considered to be a better outcome.
| Baseline to Month 3 |
| Change in the Occurrence of Dysphagia -Bazaz Scale | Change from baseline scores on the dysphagia Bazaz Scale. • Bazaz grading system is designed for the evaluation of swallowing difficulty after cervical surgery. The patients are graded on a scale as having None (0), Mild (1), Moderate (2), or Severe (3) dysphagia based on their symptoms. None (0) or Mild (1) dysphagia is considered to be a better outcome. | Baseline to Month 12 |
| Change in the Occurrence of Dysphagia -Bazaz Scale | Change from baseline scores on the dysphagia Bazaz Scale. • Bazaz grading system is designed for the evaluation of swallowing difficulty after cervical surgery. The patients are graded on a scale as having None (0), Mild (1), Moderate (2), or Severe (3) dysphagia based on their symptoms. None (0) or Mild (1) dysphagia is considered to be a better outcome. | Baseline to Month 1 |
| Change in the Occurrence of Dysphagia -Bazaz Scale | Change from baseline scores on the dysphagia Bazaz Scale. • Bazaz grading system is designed for the evaluation of swallowing difficulty after cervical surgery. The patients are graded on a scale as having None (0), Mild (1), Moderate (2), or Severe (3) dysphagia based on their symptoms. None (0) or Mild (1) dysphagia is considered to be a better outcome. | Baseline to Month 6 |
| Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ). | Change from baseline scores on the dysphagia DSQ. Dysphagia Short Questionnaire (DSQ) is designed for the evaluation of swallowing difficulty after cervical surgery. Each question is given a weighted number from 0 points up to 4 points. The total score is calculated by summing up the points given for each item with the total range being from 0 points to a maximum of 18 points. The lower scores represent milder symptoms, and higher scores represent worse symptoms. | Baseline to Day 1 |
| Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ). | Change from baseline scores on the dysphagia DSQ. • Dysphagia Short Questionnaire (DSQ) is designed for the evaluation of swallowing difficulty after cervical surgery. Each question is given a weighted number from 0 points up to 4 points. The total score is calculated by summing up the points given for each item with the total range being from 0 points to a maximum of 18 points. The lower scores represent milder symptoms, and higher scores represent worse symptoms. | Baseline to Day 2 |
| Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ). | Change from baseline scores on the dysphagia DSQ. Dysphagia Short Questionnaire (DSQ) is designed for the evaluation of swallowing difficulty after cervical surgery. Each question is given a weighted number from 0 points up to 4 points. The total score is calculated by summing up the points given for each item with the total range being from 0 points to a maximum of 18 points. The lower scores represent milder symptoms, and higher scores represent worse symptoms. | Baseline to Week 1 |
| Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ). | Change from baseline scores on the dysphagia DSQ.• Dysphagia Short Questionnaire (DSQ) is designed for the evaluation of swallowing difficulty after cervical surgery. Each question is given a weighted number from 0 points up to 4 points. The total score is calculated by summing up the points given for each item with the total range being from 0 points to a maximum of 18 points. The lower scores represent milder symptoms, and higher scores represent worse symptoms. | Baseline to Week 2 |
| Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ). | Change from baseline scores on the dysphagia DSQ.• Dysphagia Short Questionnaire (DSQ) is designed for the evaluation of swallowing difficulty after cervical surgery. Each question is given a weighted number from 0 points up to 4 points. The total score is calculated by summing up the points given for each item with the total range being from 0 points to a maximum of 18 points. The lower scores represent milder symptoms, and higher scores represent worse symptoms. | Baseline to Month 1 |
| Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ). | Change from baseline scores on the dysphagia DSQ. • Dysphagia Short Questionnaire (DSQ) is designed for the evaluation of swallowing difficulty after cervical surgery. Each question is given a weighted number from 0 points up to 4 points. The total score is calculated by summing up the points given for each item with the total range being from 0 points to a maximum of 18 points. The lower scores represent milder symptoms, and higher scores represent worse symptoms. | Baseline to Month 3 |
| Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ). | Change from baseline scores on the dysphagia DSQ.• Dysphagia Short Questionnaire (DSQ) is designed for the evaluation of swallowing difficulty after cervical surgery. Each question is given a weighted number from 0 points up to 4 points. The total score is calculated by summing up the points given for each item with the total range being from 0 points to a maximum of 18 points. The lower scores represent milder symptoms, and higher scores represent worse symptoms. | Baseline to Month 6 |
| Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ). | Change from baseline scores on the dysphagia DSQ. • Dysphagia Short Questionnaire (DSQ) is designed for the evaluation of swallowing difficulty after cervical surgery. Each question is given a weighted number from 0 points up to 4 points. The total score is calculated by summing up the points given for each item with the total range being from 0 points to a maximum of 18 points. The lower scores represent milder symptoms, and higher scores represent worse symptoms. | Baseline to Month 12 |
| Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening. | Change from baseline scores on the dysphagia EAT 10 Screening is a screening tool to help measure swallowing difficulties, dysphagia severity & monitor treatment response. It is a likert scale from 0-4, with a maximum score of 40. If the EAT-10 score is 3 or higher, this could indicate problems swallowing efficiently or safely. | Baseline to Day 1 |
| Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening. | Change from baseline scores on the dysphagia EAT 10 Screening is a screening tool to help measure swallowing difficulties, dysphagia severity & monitor treatment response. It is a likert scale from 0-4, with a maximum score of 40. If the EAT-10 score is 3 or higher, this could indicate problems swallowing efficiently or safely. | Baseline to Day 2 |
| Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening. | Change from baseline scores on the dysphagia EAT 10 Screening is a screening tool to help measure swallowing difficulties, dysphagia severity & monitor treatment response. It is a likert scale from 0-4, with a maximum score of 40. If the EAT-10 score is 3 or higher, this could indicate problems swallowing efficiently or safely. | Baseline to Week 1 |
| Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening. | Change from baseline scores on the dysphagia EAT 10 Screening is a screening tool to help measure swallowing difficulties, dysphagia severity & monitor treatment response. It is a likert scale from 0-4, with a maximum score of 40. If the EAT-10 score is 3 or higher, this could indicate problems swallowing efficiently or safely. | Baseline to Week 2 |
| Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening. | Change from baseline scores on the dysphagia EAT 10 Screening is a screening tool to help measure swallowing difficulties, dysphagia severity & monitor treatment response. It is a likert scale from 0-4, with a maximum score of 40. If the EAT-10 score is 3 or higher, this could indicate problems swallowing efficiently or safely. | Baseline to Month 1 |
| Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening. | Change from baseline scores on the dysphagia EAT 10 Screening is a screening tool to help measure swallowing difficulties, dysphagia severity & monitor treatment response. It is a likert scale from 0-4, with a maximum score of 40. If the EAT-10 score is 3 or higher, this could indicate problems swallowing efficiently or safely. | Baseline to Month 3 |
| Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening. | Change from baseline scores on the dysphagia EAT 10 Screening is a screening tool to help measure swallowing difficulties, dysphagia severity & monitor treatment response. It is a likert scale from 0-4, with a maximum score of 40. If the EAT-10 score is 3 or higher, this could indicate problems swallowing efficiently or safely. | Baseline to Month 6 |
| Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening. | Change from baseline scores on the dysphagia EAT 10 Screening is a screening tool to help measure swallowing difficulties, dysphagia severity & monitor treatment response. It is a likert scale from 0-4, with a maximum score of 40. If the EAT-10 score is 3 or higher, this could indicate problems swallowing efficiently or safely. | Baseline to Month 12 |
| 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. |
| 22037524 | Background | Skeppholm M, Ingebro C, Engstrom T, Olerud C. The Dysphagia Short Questionnaire: an instrument for evaluation of dysphagia: a validation study with 12 months' follow-up after anterior cervical spine surgery. Spine (Phila Pa 1976). 2012 May 15;37(11):996-1002. doi: 10.1097/BRS.0b013e31823a7a5b. |
| 19140539 | Background | Belafsky PC, Mouadeb DA, Rees CJ, Pryor JC, Postma GN, Allen J, Leonard RJ. Validity and reliability of the Eating Assessment Tool (EAT-10). Ann Otol Rhinol Laryngol. 2008 Dec;117(12):919-24. doi: 10.1177/000348940811701210. |
| BG001 | Treatment 0; Placebo | 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. Saline: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG001 | Treatment 0; Placebo | 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. Saline: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery |
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| Primary | Change in the Occurrence of Dysphagia -Bazaz Scale | Change from baseline scores on the dysphagia Bazaz Scale. • Bazaz grading system is designed for the evaluation of swallowing difficulty after cervical surgery. The patients are graded on a scale as having None (0), Mild (1), Moderate (2), or Severe (3) dysphagia based on their symptoms. None (0) or Mild (1) dysphagia is considered to be a better outcome. | Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline to Day 2 |
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| Primary | Change in the Occurrence of Dysphagia -Bazaz Scale | Change from baseline scores on the dysphagia Bazaz Scale. • Bazaz grading system is designed for the evaluation of swallowing difficulty after cervical surgery. The patients are graded on a scale as having None (0), Mild (1), Moderate (2), or Severe (3) dysphagia based on their symptoms. None (0) or Mild (1) dysphagia is considered to be a better outcome. | Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline to Week 1 |
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| Primary | Change in the Occurrence of Dysphagia -Bazaz Scale | Change from baseline scores on the dysphagia Bazaz Scale. • Bazaz grading system is designed for the evaluation of swallowing difficulty after cervical surgery. The patients are graded on a scale as having None (0), Mild (1), Moderate (2), or Severe (3) dysphagia based on their symptoms. None (0) or Mild (1) dysphagia is considered to be a better outcome. | Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline to Week 2 |
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| Primary | Change in the Occurrence of Dysphagia -Bazaz Scale | Change from baseline scores on the dysphagia Bazaz Scale. • Bazaz grading system is designed for the evaluation of swallowing difficulty after cervical surgery. The patients are graded on a scale as having None (0), Mild (1), Moderate (2), or Severe (3) dysphagia based on their symptoms. None (0) or Mild (1) dysphagia is considered to be a better outcome. | Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline to Month 3 |
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| Primary | Change in the Occurrence of Dysphagia -Bazaz Scale | Change from baseline scores on the dysphagia Bazaz Scale. • Bazaz grading system is designed for the evaluation of swallowing difficulty after cervical surgery. The patients are graded on a scale as having None (0), Mild (1), Moderate (2), or Severe (3) dysphagia based on their symptoms. None (0) or Mild (1) dysphagia is considered to be a better outcome. | Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline to Month 12 |
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| Primary | Change in the Occurrence of Dysphagia -Bazaz Scale | Change from baseline scores on the dysphagia Bazaz Scale. • Bazaz grading system is designed for the evaluation of swallowing difficulty after cervical surgery. The patients are graded on a scale as having None (0), Mild (1), Moderate (2), or Severe (3) dysphagia based on their symptoms. None (0) or Mild (1) dysphagia is considered to be a better outcome. | Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline to Month 1 |
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| Primary | Change in the Occurrence of Dysphagia -Bazaz Scale | Change from baseline scores on the dysphagia Bazaz Scale. • Bazaz grading system is designed for the evaluation of swallowing difficulty after cervical surgery. The patients are graded on a scale as having None (0), Mild (1), Moderate (2), or Severe (3) dysphagia based on their symptoms. None (0) or Mild (1) dysphagia is considered to be a better outcome. | Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline to Month 6 |
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| Primary | Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ). | Change from baseline scores on the dysphagia DSQ. Dysphagia Short Questionnaire (DSQ) is designed for the evaluation of swallowing difficulty after cervical surgery. Each question is given a weighted number from 0 points up to 4 points. The total score is calculated by summing up the points given for each item with the total range being from 0 points to a maximum of 18 points. The lower scores represent milder symptoms, and higher scores represent worse symptoms. | Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis. Two participants were withdrawn at surgery (treatment 1 group). | Posted | Mean | Standard Deviation | score on a scale | Baseline to Day 1 |
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| Primary | Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ). | Change from baseline scores on the dysphagia DSQ. • Dysphagia Short Questionnaire (DSQ) is designed for the evaluation of swallowing difficulty after cervical surgery. Each question is given a weighted number from 0 points up to 4 points. The total score is calculated by summing up the points given for each item with the total range being from 0 points to a maximum of 18 points. The lower scores represent milder symptoms, and higher scores represent worse symptoms. | Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis. Two participants were withdrawn at surgery (treatment 1 group). | Posted | Mean | Standard Deviation | score on a scale | Baseline to Day 2 |
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| Primary | Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ). | Change from baseline scores on the dysphagia DSQ. Dysphagia Short Questionnaire (DSQ) is designed for the evaluation of swallowing difficulty after cervical surgery. Each question is given a weighted number from 0 points up to 4 points. The total score is calculated by summing up the points given for each item with the total range being from 0 points to a maximum of 18 points. The lower scores represent milder symptoms, and higher scores represent worse symptoms. | Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis. Two participants were withdrawn at surgery (treatment 1 group). | Posted | Mean | Standard Deviation | score on a scale | Baseline to Week 1 |
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| Primary | Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ). | Change from baseline scores on the dysphagia DSQ.• Dysphagia Short Questionnaire (DSQ) is designed for the evaluation of swallowing difficulty after cervical surgery. Each question is given a weighted number from 0 points up to 4 points. The total score is calculated by summing up the points given for each item with the total range being from 0 points to a maximum of 18 points. The lower scores represent milder symptoms, and higher scores represent worse symptoms. | Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis. Two participants were withdrawn at surgery (treatment 1 group). | Posted | Mean | Standard Deviation | score on a scale | Baseline to Week 2 |
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| Primary | Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ). | Change from baseline scores on the dysphagia DSQ.• Dysphagia Short Questionnaire (DSQ) is designed for the evaluation of swallowing difficulty after cervical surgery. Each question is given a weighted number from 0 points up to 4 points. The total score is calculated by summing up the points given for each item with the total range being from 0 points to a maximum of 18 points. The lower scores represent milder symptoms, and higher scores represent worse symptoms. | Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis. Two participants were withdrawn at surgery (treatment 1 group). | Posted | Mean | Standard Deviation | score on a scale | Baseline to Month 1 |
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| Primary | Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ). | Change from baseline scores on the dysphagia DSQ. • Dysphagia Short Questionnaire (DSQ) is designed for the evaluation of swallowing difficulty after cervical surgery. Each question is given a weighted number from 0 points up to 4 points. The total score is calculated by summing up the points given for each item with the total range being from 0 points to a maximum of 18 points. The lower scores represent milder symptoms, and higher scores represent worse symptoms. | Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis. Two participants were withdrawn at surgery (treatment 1 group). | Posted | Mean | Standard Deviation | score on a scale | Baseline to Month 3 |
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| Primary | Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ). | Change from baseline scores on the dysphagia DSQ.• Dysphagia Short Questionnaire (DSQ) is designed for the evaluation of swallowing difficulty after cervical surgery. Each question is given a weighted number from 0 points up to 4 points. The total score is calculated by summing up the points given for each item with the total range being from 0 points to a maximum of 18 points. The lower scores represent milder symptoms, and higher scores represent worse symptoms. | Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis. Two participants were withdrawn at surgery (treatment 1 group). | Posted | Mean | Standard Deviation | score on a scale | Baseline to Month 6 |
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| Primary | Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ). | Change from baseline scores on the dysphagia DSQ. • Dysphagia Short Questionnaire (DSQ) is designed for the evaluation of swallowing difficulty after cervical surgery. Each question is given a weighted number from 0 points up to 4 points. The total score is calculated by summing up the points given for each item with the total range being from 0 points to a maximum of 18 points. The lower scores represent milder symptoms, and higher scores represent worse symptoms. | Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis. Two participants were withdrawn at surgery (treatment 1 group). | Posted | Mean | Standard Deviation | score on a scale | Baseline to Month 12 |
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| Primary | Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening. | Change from baseline scores on the dysphagia EAT 10 Screening is a screening tool to help measure swallowing difficulties, dysphagia severity & monitor treatment response. It is a likert scale from 0-4, with a maximum score of 40. If the EAT-10 score is 3 or higher, this could indicate problems swallowing efficiently or safely. | Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis. Two participants were withdrawn at surgery (treatment 1 group). | Posted | Mean | Standard Deviation | score on a scale | Baseline to Day 1 |
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| Primary | Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening. | Change from baseline scores on the dysphagia EAT 10 Screening is a screening tool to help measure swallowing difficulties, dysphagia severity & monitor treatment response. It is a likert scale from 0-4, with a maximum score of 40. If the EAT-10 score is 3 or higher, this could indicate problems swallowing efficiently or safely. | Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis. Two participants were withdrawn at surgery (treatment 1 group). | Posted | Mean | Standard Deviation | score on a scale | Baseline to Day 2 |
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| Primary | Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening. | Change from baseline scores on the dysphagia EAT 10 Screening is a screening tool to help measure swallowing difficulties, dysphagia severity & monitor treatment response. It is a likert scale from 0-4, with a maximum score of 40. If the EAT-10 score is 3 or higher, this could indicate problems swallowing efficiently or safely. | Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis. Two participants were withdrawn at surgery (treatment 1 group). | Posted | Mean | Standard Deviation | score on a scale | Baseline to Week 1 |
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| Primary | Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening. | Change from baseline scores on the dysphagia EAT 10 Screening is a screening tool to help measure swallowing difficulties, dysphagia severity & monitor treatment response. It is a likert scale from 0-4, with a maximum score of 40. If the EAT-10 score is 3 or higher, this could indicate problems swallowing efficiently or safely. | Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis. Two participants were withdrawn at surgery (treatment 1 group). | Posted | Mean | Standard Deviation | score on a scale | Baseline to Week 2 |
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| Primary | Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening. | Change from baseline scores on the dysphagia EAT 10 Screening is a screening tool to help measure swallowing difficulties, dysphagia severity & monitor treatment response. It is a likert scale from 0-4, with a maximum score of 40. If the EAT-10 score is 3 or higher, this could indicate problems swallowing efficiently or safely. | Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis. Two participants were withdrawn at surgery (treatment 1 group). | Posted | Mean | Standard Deviation | score on a scale | Baseline to Month 1 |
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| Primary | Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening. | Change from baseline scores on the dysphagia EAT 10 Screening is a screening tool to help measure swallowing difficulties, dysphagia severity & monitor treatment response. It is a likert scale from 0-4, with a maximum score of 40. If the EAT-10 score is 3 or higher, this could indicate problems swallowing efficiently or safely. | Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis. Two participants were withdrawn at surgery (treatment 1 group). | Posted | Mean | Standard Deviation | score on a scale | Baseline to Month 3 |
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| Primary | Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening. | Change from baseline scores on the dysphagia EAT 10 Screening is a screening tool to help measure swallowing difficulties, dysphagia severity & monitor treatment response. It is a likert scale from 0-4, with a maximum score of 40. If the EAT-10 score is 3 or higher, this could indicate problems swallowing efficiently or safely. | Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis. Two participants were withdrawn at surgery (treatment 1 group). | Posted | Mean | Standard Deviation | score on a scale | Baseline to Month 6 |
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| Primary | Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening. | Change from baseline scores on the dysphagia EAT 10 Screening is a screening tool to help measure swallowing difficulties, dysphagia severity & monitor treatment response. It is a likert scale from 0-4, with a maximum score of 40. If the EAT-10 score is 3 or higher, this could indicate problems swallowing efficiently or safely. | Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis. Two participants were withdrawn at surgery (treatment 1 group). | Posted | Mean | Standard Deviation | score on a scale | Baseline to Month 12 |
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| 2 |
| 40 |
| 0 |
| 40 |
| 25 |
| 40 |
| EG001 | Treatment 0; Placebo | 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. Saline: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery | 1 | 38 | 0 | 38 | 30 | 38 |
| Sore throat | Gastrointestinal disorders | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| PE/DVT | Cardiac disorders | Systematic Assessment |
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| joint pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Chest Pain | Cardiac disorders | Systematic Assessment |
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| Dizziness | Ear and labyrinth disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Infection | Infections and infestations | Systematic Assessment |
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| Urinary Retention | Renal and urinary disorders | Systematic Assessment |
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| laceration | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Falls | Social circumstances | Systematic Assessment |
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| Planned surgical interventions | Surgical and medical procedures | Systematic Assessment |
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| numbness/tingling | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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Not provided
Not provided
| D010038 | Otorhinolaryngologic Diseases |
| D011083 |
| Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |