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This prospective, randomized, double blind, controlled study evaluates the effect of perioperative IV steroids versus saline on swallowing after anterior cervical spine surgery.
This investigation is a prospective, randomized, double-blind, controlled trial testing peri-operative steroids versus saline and the effect on swallowing after anterior cervical spine surgery. Swallowing symptoms will be measured using the patient reported Bazaz (Bazaz) scale 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 | Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz 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 0.3 mg/kg of intravenous dexamethasone within one hour of the incision, then 0.15 mg/kg every eight hours for two doses. This dosage is approximately 20 mg, 10 mg, and 10 mg of dexamethasone. Patients in the control(saline) group will receive a similar volume of saline on the same schedule for three doses. |
|
| Treatment 0; Saline placebo | Placebo Comparator | Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz 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 0.3 mg/kg of intravenous dexamethasone within one hour of the incision, then 0.15 mg/kg every eight hours for two doses. This dosage is approximately 20 mg, 10 mg, and 10 mg of dexamethasone. Patients in the control(saline) group will receive a similar volume of saline on the same schedule for three doses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment 1; Dexamethasone | Drug | Dexamethasone IV given within the first hour of surgery; second dose given 8 hours after first dose; third dose given 8 hours after second dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Swallowing Difficulty | Two measurement surveys were used: The Dysphagia Short Questionnaire: An Instrument for Evaluation of Dysphagia (DSQ) and Bazaz Dysphagia Scale (Bazaz). The DSQ and Bazaz determine levels of dysphagia over time after anterior cervical spine surgery. A DSQ score of zero indicates no symptoms. Any number above zero indicates difficulty swallowing. The Bazaz score of Zero indicates no symptoms. Any number above zero indicates difficulty swallowing. Numbers of subjects reporting any difficulty swallowing (had to have a score of at least 1) at various time points are listed below associated with the randomization assignment and survey used. | 1 day; 2 days; 1 week; 2 weeks; 1 month; 3 months; 6 months;12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life | Change in Quality of life measured by the Neck Disability Index (NDI) from baseline and 1 year for Treatment 1; Dexamethasone and Treatment 0; Saline placebo. The NDI measures self-rated disability due to neck pain. Each of the 10 items is scored from 0 - 5. The maximum score is 50. The higher the score the more disability. The scale is 0 - 4 = no disability; 5 - 14 = mild;15 - 24 = moderate; 25 - 34 = severe; above 34 = complete disability. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sanford E Emery, MD, MBA | West Virginia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Virginia University | Morgantown | West Virginia | 26506 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20407354 | Background | Riley LH 3rd, Vaccaro AR, Dettori JR, Hashimoto R. Postoperative dysphagia in anterior cervical spine surgery. Spine (Phila Pa 1976). 2010 Apr 20;35(9 Suppl):S76-85. doi: 10.1097/BRS.0b013e3181d81a96. | |
| 18091507 | Background | Fountas KN. Re: Papavero L, Heese O, Klotz-Regener V, et al. The impact of esophagus retraction on early dysphagia after anterior cervical surgery. Spine 2007;32:1089-93. Spine (Phila Pa 1976). 2007 Dec 15;32(26):3090. doi: 10.1097/BRS.0b013e31815cd40f. No abstract available. |
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Group data will be available via publication. Participants are told their randomization assignment at one year, or up to two year, follow up post surgery, dependent on their return to clinic.
Within one year of study completion
Through a published manuscript and to participants via phone call or clinic visit when the participants return for regularly scheduled follow up visits.
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Potential participants undergoing elective anterior cervical spine surgery will be seen by spine surgeons at the WVU Spine Center. Participants will be told about the study and given the opportunity to consent. Consented participants will be randomized to either the steroid administration group or the saline administration group.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment 1; Dexamethasone | Swallowing difficulty at various time points as measured by the DSQ and Bazaz for subjects randomized to Treatment 1; Dexamethasone |
| FG001 | Treatment 0; Saline Placebo | Swallowing difficulty at various time points as measured by the DSQ and Bazaz for subjects randomized to Treatment 0; Saline placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Ten participant's data was not analyzed for various reasons.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment 1; Dexamethasone | Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz 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 0.3 mg/kg of intravenous dexamethasone within one hour of the incision, then 0.15 mg/kg every eight hours for two doses. This dosage is approximately 20 mg, 10 mg, and 10 mg of dexamethasone. Patients in the control(saline) group will receive a similar volume of saline on the same schedule for three doses. Treatment 1; Dexamethasone: Dexamethasone IV given within the first hour of surgery; second dose given 8 hours after first dose; third dose given 8 hours after second dose. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Ten total subjects were removed from the study for various reasons. |
| 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 | Swallowing Difficulty | Two measurement surveys were used: The Dysphagia Short Questionnaire: An Instrument for Evaluation of Dysphagia (DSQ) and Bazaz Dysphagia Scale (Bazaz). The DSQ and Bazaz determine levels of dysphagia over time after anterior cervical spine surgery. A DSQ score of zero indicates no symptoms. Any number above zero indicates difficulty swallowing. The Bazaz score of Zero indicates no symptoms. Any number above zero indicates difficulty swallowing. Numbers of subjects reporting any difficulty swallowing (had to have a score of at least 1) at various time points are listed below associated with the randomization assignment and survey used. | Treatment 1; Dexamethasone or Treatment 0; Saline placebo. Treatment 1 received 0.3 mg/kg of intravenous dexamethasone within one hour of the incision, then 0.15 mg/kg every eight hours for two doses. Dosage was approximately 20 mg, 10 mg, and 10 mg of dexamethasone. Treatment 0 received similar volume of saline on same schedule for three doses. | Posted | Count of Participants | Participants | 1 day; 2 days; 1 week; 2 weeks; 1 month; 3 months; 6 months;12 months |
|
up to 1 year
Other not including serious adverse events
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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 | Swallowing difficulty. Two measurement surveys were used: The Dysphagia Short Questionnaire: An Instrument for Evaluation of Dysphagia (DSQ) and Bazaz Dysphagia Scale (Bazaz). The DSQ and Bazaz determine levels of dysphagia over time after anterior cervical spine surgery. A DSQ score is calculated by summing up the points given for each item to a maximum of 18 points, where lower scores represent milder symptoms (zero indicates no symptoms) and vice versa. For the Bazaz score, symptoms are measured as 'none', 'mild', 'moderate', or 'severe'. Zero indicates none or no symptoms, 1 indicates mild, 2 indicates moderate, 3 indicates severe. Numbers of subjects reporting any difficulty swallowing (had to have a score of at least 1) at various time points are reported. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| intraoperative musculoskeletal injury | Surgical and medical procedures | MedDRA (10.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sanford Emery | West Virginia University Department of Orthopaedics | 304-293-1170 | semery@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 | Yes | No | No | Study Protocol | May 28, 2014 | Mar 27, 2018 | Prot_000.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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|
| Treatment 0; Saline placebo | Drug | Saline (placebo) IV given within the first hour of surgery; second dose given 8 hours after first dose; third dose given 8 hours after second dose. |
|
|
| Baseline and 1 year (or last visit as appropriate). Not all subjects followed up at 1 year. |
| Fusion Rate Steroid vs Placebo | Participants were considered fused if radiographs demonstrated less than 1 millimeter of interspinous motion between flexion and extension,7 or if CT/MRI demonstrated clear evidence of bone bridging from endplate to endplate. | 1 year |
| 18245583 | Background | Mendoza-Lattes S, Clifford K, Bartelt R, Stewart J, Clark CR, Boezaart AP. Dysphagia following anterior cervical arthrodesis is associated with continuous, strong retraction of the esophagus. J Bone Joint Surg Am. 2008 Feb;90(2):256-63. doi: 10.2106/JBJS.G.00258. |
| 19929356 | Background | Cavusoglu H, Tuncer C, Tanik C, Mutlu Z, Zengin E, Karabagli M, Aydin Y. The impact of automatic retractors on the esophagus during anterior cervical surgery: an experimental in vivo study in a sheep model. J Neurosurg Spine. 2009 Nov;11(5):547-54. doi: 10.3171/2009.6.SPINE09216. |
| 17321961 | Background | Lee MJ, Bazaz R, Furey CG, Yoo J. Risk factors for dysphagia after anterior cervical spine surgery: a two-year prospective cohort study. Spine J. 2007 Mar-Apr;7(2):141-7. doi: 10.1016/j.spinee.2006.02.024. Epub 2007 Jan 22. |
| 21140251 | Background | Rihn JA, Kane J, Albert TJ, Vaccaro AR, Hilibrand AS. What is the incidence and severity of dysphagia after anterior cervical surgery? Clin Orthop Relat Res. 2011 Mar;469(3):658-65. doi: 10.1007/s11999-010-1731-8. |
| 21785303 | Background | Siska PA, Ponnappan RK, Hohl JB, Lee JY, Kang JD, Donaldson WF 3rd. Dysphagia after anterior cervical spine surgery: a prospective study using the swallowing-quality of life questionnaire and analysis of patient comorbidities. Spine (Phila Pa 1976). 2011 Aug 1;36(17):1387-91. doi: 10.1097/BRS.0b013e31822340f2. |
| 21798743 | Background | Kang SH, Kim DK, Seo KM, Kim KT, Kim YB. Multi-level spinal fusion and postoperative prevertebral thickness increase the risk of dysphagia after anterior cervical spine surgery. J Clin Neurosci. 2011 Oct;18(10):1369-73. doi: 10.1016/j.jocn.2011.02.033. Epub 2011 Jul 27. |
| 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. |
| 16284596 | Background | Riley LH 3rd, Skolasky RL, Albert TJ, Vaccaro AR, Heller JG. Dysphagia after anterior cervical decompression and fusion: prevalence and risk factors from a longitudinal cohort study. Spine (Phila Pa 1976). 2005 Nov 15;30(22):2564-9. doi: 10.1097/01.brs.0000186317.86379.02. |
| 12592551 | Background | Pedram M, Castagnera L, Carat X, Macouillard G, Vital JM. Pharyngolaryngeal lesions in patients undergoing cervical spine surgery through the anterior approach: contribution of methylprednisolone. Eur Spine J. 2003 Feb;12(1):84-90. doi: 10.1007/s00586-002-0495-6. Epub 2002 Dec 4. |
| 19148042 | Background | Emery SE, Akhavan S, Miller P, Furey CG, Yoo JU, Rowbottom JR, Bohlman HH. Steroids and risk factors for airway compromise in multilevel cervical corpectomy patients: a prospective, randomized, double-blind study. Spine (Phila Pa 1976). 2009 Feb 1;34(3):229-32. doi: 10.1097/BRS.0b013e318193a287. |
| 22020609 | Background | Lee SH, Kim KT, Suk KS, Park KJ, Oh KI. Effect of retropharyngeal steroid on prevertebral soft tissue swelling following anterior cervical discectomy and fusion: a prospective, randomized study. Spine (Phila Pa 1976). 2011 Dec 15;36(26):2286-92. doi: 10.1097/BRS.0b013e318237e5d0. |
| Withdrawal by Subject |
|
| recruited during continuing renewal proc |
|
| Protocol Violation |
|
| surgery started late |
|
| re-operation |
|
| BG001 | Treatment 0; Saline Placebo | Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz 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 0.3 mg/kg of intravenous dexamethasone within one hour of the incision, then 0.15 mg/kg every eight hours for two doses. This dosage is approximately 20 mg, 10 mg, and 10 mg of dexamethasone. Patients in the control(saline) group will receive a similar volume of saline on the same schedule for three doses. Treatment 0; Saline placebo: Saline (placebo) IV given within the first hour of surgery; second dose given 8 hours after first dose; third dose given 8 hours after second dose. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | The Dysphagia Short Questionnaire: An Instrument for Evaluation of Dysphagia (DSQ) and Bazaz Dysphagia Scale (Bazaz) were administered in person at baseline and Day 1, via phone call Day 2, Week 1,2; 1,3, 6 months, and 1 year. | Number | participants |
|
| Description |
|---|
| OG000 | Dexamethasone DSQ | Treatment 1; Dexamethasone. Patients undergoing elective anterior cervical spine surgery were seen by spine surgeons. After consent the Bazaz and Dysphagia Short Questionnaire were 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 were randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group received 0.3 mg/kg of intravenous dexamethasone within one hour of the incision, then 0.15 mg/kg every eight hours for two doses. This dosage is approximately 20 mg, 10 mg, and 10 mg of dexamethasone. Treatment 1; Dexamethasone: Dexamethasone IV given within the first hour of surgery; second dose given 8 hours after first dose; third dose given 8 hours after second dose. |
| OG001 | Saline Placebo DSQ | Treatment 0; Saline Placebo. Patients undergoing elective anterior cervical spine surgery wereseen by spine surgeons. After consent the Bazaz and Dysphagia Short Questionnaire were 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 were randomized to either the steroid administration group or the saline administration group. Patients randomized to the control (saline) group received 0.3 mg/kg of intravenous saline within one hour of the incision, then 0.15 mg/kg every eight hours for two doses. This dosage is approximately 20 mg, 10 mg, and 10 mg of saline. Treatment 0; Control (Saline) IV given within the first hour of surgery; second dose given 8 hours after first dose; third dose given 8 hours after second dose. |
| OG002 | Dexamethasone Bazaz | Treatment 1; Dexamethasone. Treatment 1; Dexamethasone. Patients undergoing elective anterior cervical spine surgery were seen by spine surgeons. After consent the Bazaz and Dysphagia Short Questionnaire were 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 were randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group received 0.3 mg/kg of intravenous dexamethasone within one hour of the incision, then 0.15 mg/kg every eight hours for two doses. This dosage is approximately 20 mg, 10 mg, and 10 mg of dexamethasone. Treatment 1; Dexamethasone: Dexamethasone IV given within the first hour of surgery; second dose given 8 hours after first dose; third dose given 8 hours after second dose. |
| OG003 | Saline Placebo Bazaz | Treatment 0; Saline Placebo. Treatment 0; Saline Placebo. Patients undergoing elective anterior cervical spine surgery wereseen by spine surgeons. After consent the Bazaz and Dysphagia Short Questionnaire were 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 were randomized to either the steroid administration group or the saline administration group. Patients randomized to the control (saline) group received 0.3 mg/kg of intravenous saline within one hour of the incision, then 0.15 mg/kg every eight hours for two doses. This dosage is approximately 20 mg, 10 mg, and 10 mg of saline. Treatment 0; Control (Saline) IV given within the first hour of surgery; second dose given 8 hours after first dose; third dose given 8 hours after second dose. |
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|
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| Secondary | Change in Quality of Life | Change in Quality of life measured by the Neck Disability Index (NDI) from baseline and 1 year for Treatment 1; Dexamethasone and Treatment 0; Saline placebo. The NDI measures self-rated disability due to neck pain. Each of the 10 items is scored from 0 - 5. The maximum score is 50. The higher the score the more disability. The scale is 0 - 4 = no disability; 5 - 14 = mild;15 - 24 = moderate; 25 - 34 = severe; above 34 = complete disability. | Neck Disability Index change from baseline to 1 year or last visit as appropriate. Not all subjects followed up at 1 year. | Posted | Mean | Standard Error | units on a scale | Baseline and 1 year (or last visit as appropriate). Not all subjects followed up at 1 year. |
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|
|
| Secondary | Fusion Rate Steroid vs Placebo | Participants were considered fused if radiographs demonstrated less than 1 millimeter of interspinous motion between flexion and extension,7 or if CT/MRI demonstrated clear evidence of bone bridging from endplate to endplate. | Posted | Count of Participants | Participants | 1 year |
|
|
|
|
| 0 |
| 33 |
| 0 |
| 33 |
| 0 |
| 33 |
| EG001 | Treatment 0; Saline Placebo | Swallowing difficulty. Two measurement surveys were used: The Dysphagia Short Questionnaire: An Instrument for Evaluation of Dysphagia (DSQ) and Bazaz Dysphagia Scale (Bazaz). The DSQ and Bazaz determine levels of dysphagia over time after anterior cervical spine surgery. A DSQ score is calculated by summing up the points given for each item to a maximum of 18 points, where lower scores represent milder symptoms (zero indicates no symptoms) and vice versa. For the Bazaz score, symptoms are measured as 'none', 'mild', 'moderate', or 'severe'. Zero indicates none or no symptoms, 1 indicates mild, 2 indicates moderate, 3 indicates severe. Numbers of subjects reporting any difficulty swallowing (had to have a score of at least 1) at various time points are reported. | 0 | 31 | 0 | 31 | 0 | 31 |
| intraoperative neurological injury | Surgical and medical procedures | MedDRA (10.0) | Non-systematic Assessment |
|
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| D010038 | Otorhinolaryngologic Diseases |
| D011083 |
| Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| not fused |
|